Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
120
Countries
6
Sites
31
Moderate to severe chronic peripheral neuropathic pain (PNP) due to postherpetic neuralgia (PHN) or peripheral nerve injury.
To establish evidence of efficacy of NT 201 in the treatment of moderate to severe chronic PNP in patients with postherpetic neuralgia or chronic neuropathic pain after peripheral nerve injury by demonstrating superiority compared to placebo in reducing Average Daily Pain (ADP) intensity.
Key facts
- Sponsor
- Merz Therapeutics GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 17 Oct 2023 → 16 Jun 2025
- Decision date (initial)
- 2023-04-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Merz Therapeutics GmbH
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To establish evidence of efficacy of NT 201 in the treatment of moderate to severe chronic PNP in patients with postherpetic neuralgia or chronic neuropathic pain after peripheral nerve injury by demonstrating superiority compared to placebo in reducing Average Daily Pain (ADP) intensity.
Secondary objectives 2
- To estimate the effect size of NT 201 in the treatment of moderate to severe chronic PNP in patients with postherpetic neuralgia or chronic neuropathic pain after peripheral nerve injury compared to placebo in reducing the Neuropathic Pain Symptom Inventory (NPSI) total score.
- To demonstrate safety and tolerability of NT 201 compared to placebo in participants with postherpetic neuralgia or chronic neuropathic pain after peripheral nerve injury.
Conditions and MedDRA coding
Moderate to severe chronic peripheral neuropathic pain (PNP) due to postherpetic neuralgia (PHN) or peripheral nerve injury.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10077974 | Peripheral neuropathic pain | 10029205 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Period 7-11 days screening period.
|
Not Applicable | None | ||
| 2 | Treatment and Follow-Up Period Participants will be randomized to receive either subcutaneous injections with NT201 or placebo. Paracetamol is permitted as rescue medication. The single treatment session is followed by a 20 week double-blind follow-up period.
|
Randomised Controlled | Double | [{"id":99163,"code":4,"name":"Analyst"},{"id":99165,"code":3,"name":"Monitor"},{"id":99162,"code":2,"name":"Investigator"},{"id":99164,"code":1,"name":"Subject"}] | NT 201: Subcutaneous injections of up to 300 units NT 201 into the PNP area. Plabebo: Subcutaneous injections of placebo into the PNP area. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Chronic PNP that persists for at least 6 months by the time of the screening visit and is plausibly related to either an episode of herpes zoster or a peripheral nerve injury (caused by surgery or mechanical trauma).
- Documented diagnosis of either chronic neuropathic pain after peripheral nerve injury (i.e., postsurgical/post-traumatic neuropathic pain) or PHN with at least probable level of certainty according to the NeuPSIG/IASP grading system.
- A score of at least 4 out of 10 points on the Neuropathic Pain 4 Questions (DN4) questionnaire.
Exclusion criteria 3
- Complex Regional Pain Syndrome Type 1 and Type 2.
- Any other painful condition or disease that requires regular treatment (only mild to moderate episodic migraine treated with triptans and/or non-steroidal anti-inflammatory drugs (NSAIDs), if any, is acceptable).
- Postsurgical/post-traumatic neuropathic pain due to limb amputation and/or phantom limb pain.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Weekly averages of changes from baseline in ADP intensity at Weeks 2 to 12.
Secondary endpoints 2
- Changes from baseline in NPSI total score at Weeks 2 to 12.
- Incidence of treatmentemergent adverse events (TEAEs) related to study intervention as assessed by the investigator from intervention to end of study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
SUB26174 · Substance
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 U unit(s)
- Max total dose
- 300 U unit(s)
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical trial specific IMP labelling
XEOMIN 100 Einheiten Pulver zur Herstellung einer Injektionslösung
PRD57997 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 U unit(s)
- Max total dose
- 300 U unit(s)
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- 57093.00.00
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical trial specific IMP labelling
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 1
SUB09611MIG · Substance
- Active substance
- Paracetamol
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 4000 mg milligram(s)
- Max total dose
- 560 g gram(s)
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Additional clinical trial specific labelling
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merz Therapeutics GmbH
- Sponsor organisation
- Merz Therapeutics GmbH
- Address
- Eckenheimer Landstrasse 100, Nordend-West Nordend-West
- City
- Frankfurt am Main
- Postcode
- 60318
- Country
- Germany
Scientific contact point
- Organisation
- Merz Therapeutics GmbH
- Contact name
- Contact Point Clinical Trials
Public contact point
- Organisation
- Merz Therapeutics GmbH
- Contact name
- Contact Point Clinical Trials
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Medable Inc. ORG-100043083
|
Palo Alto, United States | E-data capture |
| Cyntegrity Germany GmbH ORG-100043933
|
Hofheim Am Taunus, Germany | Other |
| Almac Clinical Services (Ireland) Limited ORG-100033336
|
Dundalk, Ireland | Code 14 |
| Almac ORG-100013160
|
Souderton, United States | Interactive response technologies (IRT) |
| Infraserv GmbH & Co. Hochst KG ORG-100045192
|
Frankfurt Am Main, Germany | Other |
| Metronomia Clinical Research GmbH ORG-100012892
|
Munich, Germany | Data management, E-data capture |
| Pharm-Olam International (UK) Limited ORG-100008801
|
Bracknell, United Kingdom | On site monitoring, Code 5 |
| Eurofins Central Laboratory B.V. ORG-100036990
|
Breda, Netherlands | Laboratory analysis |
Locations
6 EU/EEA countries · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 20 | 5 |
| France | Ended | 12 | 3 |
| Germany | Ended | 20 | 6 |
| Hungary | Ended | 12 | 3 |
| Poland | Ended | 44 | 10 |
| Spain | Ended | 12 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Synexus Bulgaria EOOD
NA, Mladost 1 District, Bul. Andrey Saharov 20a, Sofia
Multi Profile Hospital For Active Treatment Trimontium OOD
Internal Diseases Department, Tsar Boris III Obedinitel Blvd 126, 4000, Plovdiv
University Hospital Of Neurology And Psychiatry
Nerve Diseases Clinic for Neurodegenerative and Peripheral Nerve Diseases, Ul. Dr. Lyuben Rusev 1, 1113, Sofia
Medical Center Medica Plus Ltd.
NA, Ulitsa Sergey Rumyantsev 63, 5006, Veliko Tirnovo
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Neurolgy Department, Krasno Selo, Bulevard Gen Totleben 21, Sofiya
Centre Hospitalier Universitaire De Nimes
Pain Medicine, 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Hopital Ambroise Pare
Head of the Pain Center, 9 Avenue Charles De Gaulle, 92100, Boulogne-Billancourt
Centre Hospitalier Universitaire De Limoges
Chronic Pain Center, 2 Avenue Martin Luther King, 87000, Limoges
Dr. Med Joachim Springub Facharzt Fur Neurologie U Psychiatrie Zusatzbezeichnung Psychotherapie Wolfgang Schwarz Facharzt Fur Neurologie Zusatzbezeichnung Psychotherapie Partnerschaft
Not applicable, Lange Straße 25, 26655, Westerstede
Synexus Clinical Research GmbH
Research Site Leipzig, Johannisplatz 1, Zentrum-Suedost, Leipzig
Synexus Clinical Research GmbH
Site Operations - Frankfurt, Bleichstrasse 55, Innenstadt, Frankfurt Am Main
Universitaetsklinikum Essen AöR
Neurology, Hufelandstrasse 55, Holsterhausen, Essen
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
Clinical Studies, Mönckebergstraße 27, Hamburg-Altstadt, Hamburg
University Medical Centre Schleswig-Holstein
Anesthesiology and Intensive Care Medicine, Interdisciplinary Pain, Palliative Care Outpatient Clini, Arnold-Heller-Straße 3, Brunswik, Kiel
Uzsoki Street Hospital
Neurologiai Osztaly, Uzsoki Utca 29-41, 1145, Budapest XIV
Koranyi National Institute For Pulmonology
Fajdalom Ambulancia, Koranyi Frigyes Ut 1, 1121, Budapest XII
SYNEXUS Magyarorszag Kft.
NA, Becsi Ut 61, 1036, Budapest III
Synexus Polska Sp. z o.o.
Synexus Polska Sp. z o.o. Oddzial w Katowicach, Ul. Konckiego 3, 40-040, Katowice
Clinical Best Solutions Sp. z o.o. S.K.
Clinical Best Solutions Sp. Z o.o., Ul. Ludwika Idzikowskiego 16, 00-710, Warsaw
Clinical Best Solutions Sp. z o.o. S.K.
Clinical Best Solutions Sp. Z o.o., Aleja Jozefa Pilsudskiego 11, 20-011, Lublin
Synexus Polska Sp. z o.o.
Synexus Polska Sp. z o.o. Oddzial w Poznaniu, Ul. Glogowska 31/33, 60-702, Poznan
Synexus Polska Sp. z o.o.
Synexus Polska Sp. Z o.o. Oddzial w Czestochowie, Aleja Najswietszej Maryi Panny 15, 42-202, Czestochowa
Specjalistyczne Gabinety Sp. z o.o.
Specjalistyczne Gabinety Sp. z o.o., Pl. Lasoty 4, 30-539, Cracow
Synexus Polska Sp. z o.o.
Synexus Polska Sp. z o.o. Oddzial w Gdyni, Ul. Luzycka 3c, 81-537, Gdynia
Synexus Polska Sp. z o.o.
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu, Ul. Marii Curie-Sklodowskiej 12, 50-381, Wroclaw
Silmedic Sp. z o.o.
SILMEDIC Sp. z o. o., Ul. Gen. Wladyslawa Sikorskiego 30 Lok 70, 40-282, Katowice
Synexus Polska Sp. z o.o.
Synexus Polska Sp. z o.o. Oddzial w Warszawie, Ul. Ulica Domaniewska 49, 02-672, Warsaw
University Hospital Virgen Del Rocio S.L.
Pediatric Anesthesiolgy, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitari Vall D Hebron
Anesthesiology and Pain Department (Pain unit), Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Bellvitge University Hospital
Anesthesiology and Pain Department, Carretera De La Feixa Llarga S/n, Poligono Industrial De La Zona Ranca De Barcelona, L'hospitalet De Llobregat
Hospital Universitario Reina Sofia
Anesthesiology - Pain Unit, Avenida Menendez Pidal S/n, 14004, Cordoba
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Bulgaria | 2023-10-24 | 2025-06-16 | 2024-01-29 | 2025-02-03 | |
| France | 2023-11-10 | 2025-04-30 | 2024-03-04 | 2025-02-03 | |
| Germany | 2023-10-19 | 2025-03-10 | 2023-12-11 | 2025-02-03 | |
| Hungary | 2023-11-02 | 2025-02-27 | 2024-01-16 | 2025-02-03 | |
| Poland | 2023-10-17 | 2025-07-01 | 2023-11-22 | 2025-02-03 | |
| Spain | 2023-11-08 | 2025-07-04 | 2024-01-26 | 2025-02-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 189 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-501461-52-00 | 3 |
| Recruitment arrangements (for publication) | 11497 EMEA CAROUSEL AD_Chronic Nerve Pain_DE_AW_EN_November2022_German | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA CAROUSEL AD_Chronic Nerve Pain_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA EMAIL __Chronic Nerve Pain__DE_AW_EN_November2022_German | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA EMAIL _Chronic Nerve Pain_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA FOLLOW-UP EMAIL _Chronic Nerve Pain_DE_AW_EN_Nov22_German | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA FOLLOW-UP EMAIL 1_Nerve Pain_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA KEYWORD SEARCH_Chronic Nerve Pain_ DE_AW_EN_November2022_German | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA KEYWORD SEARCH_Chronic Nerve Pain_ PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA RADIO ADS_Chronic Nerve Pain_DE_AW_EN_Nov 2022_German | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA RADIO ADS_Chronic Nerve Pain_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA SMS_Chronic Nerve Pain_DE_AW_EN_November2022_German | 1 |
| Recruitment arrangements (for publication) | 11497 EMEA SMS_Chronic Nerve Pain_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497 Social Video_Chronic Nerve Pain_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA ADVERTORIAL__Chronic Nerve Pain_DE_AW_EN_Nov2022_German | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA ADVERTORIAL_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA POSTER_Chronic Nerve Pain_AW_BG_October2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | 11497_EMEA POSTER_Chronic Nerve Pain_AW_PL_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA POSTER_Chronic Nerve Pain_DE_AW_EN_November2022_German | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA POSTER_Chronic Nerve Pain_DE_AW_November2022_German_UPDATE | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA POSTER_Chronic Nerve Pain_HU_AW_November2022_Hungarian ONLY | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA PRINT AND BANNER_Chronic Nerve Pain_DE_AW_EN_Nov2022_German | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA PRINT AND BANNER_Chronic Nerve Pain_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA SOCIAL MEDIA_Chronic Nerve Pain_DE_AW_EN_November 2022_German | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA SOCIAL MEDIA_Chronic Nerve Pain_DE_AW_November 2022_German_UPDATE | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA SOCIAL MEDIA_Nerve Pain_BG_AW_November 2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | 11497_EMEA SOCIAL MEDIA_Nerve Pain_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA SYN LANDING PAGE_Chronic Nerve Pain_DE_AW_EN_November2022_German | 1 |
| Recruitment arrangements (for publication) | 11497_EMEA SYN LANDING PAGE_Chronic Nerve Pain_PL_AW_Polish_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_ 2022-501461-52-00_ESP_Template recruitment arrangements | 4.0 |
| Recruitment arrangements (for publication) | K1_ 2022-501461-52-00_HUN_Template recruitment arrangements | 3.0 |
| Recruitment arrangements (for publication) | K1_ 2022-501461-52-00_POL_Template recruitment arrangements | 3.0 |
| Recruitment arrangements (for publication) | K1_BG_Recruitment arrangements_For publication | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_For publication | 3.0 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_HU_Recruitment material_Advertorial | 1 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_HU_Recruitment material_Doctor email | 1 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_HU_Recruitment material_GP leaflet | 1 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_HU_Recruitment material_Landing page | 1 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_HU_Recruitment material_Patient email | 1 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_HU_Recruitment material_Patient leaflet | 1 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_HU_Recruitment material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_HU_Recruitment material_Print AD | 4 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_HU_Recruitment material_SMS | 1 |
| Recruitment arrangements (for publication) | K2_ 2022-501461-52-00_POL_AES Generic Prescreening Strategy | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BG_Recruitment material_Banners_BG_Redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BG_Recruitment material_BG_Social Images_BG_redacted_s | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BG_Recruitment material_Email Banners_BG_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BG_Recruitment material_EMEA CAROUSEL AD_BG_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BG_Recruitment material_EMEA SOCIAL VIDEO_BG_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BG_Recruitment material_PaiNT_Ad1_BG_Redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BG_Recruitment material_PaiNT_Ad2_BG_Redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BG_Recruitment material_POSTER_BG_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BG_Recruitment material_Print Ads_BG_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497 EMEA CAROUSEL AD_Chronic Nerve Pain_BG_AW_EN_October2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497 EMEA EMAIL __Chronic Nerve Pain___BG_AW_EN_November2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497 EMEA FOLLOW-UP EMAIL 1_Nerve Pain_BG_AW_EN_October2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497 EMEA KEYWORD SEARCH_Chronic Nerve Pain_ BG_AW_EN_Oct2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497 EMEA RADIO ADS_Chronic Nerve Pain_BG_AW_EN_Nov 2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497 EMEA SMS_Chronic Nerve Pain_BG_AW_EN_October2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497_EMEA ADVERTORIAL_Chronic Nerve Pain_BG_AW _November 2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497_EMEA POSTER_Chronic Nerve Pain_AW_BG_EN_October2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497_EMEA PRINT AND BANNER_Chronic Nerve Pain_BG_AW_EN_Nov2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497_EMEA SOCIAL MEDIA_Nerve Pain_BG_AW_EN_November 2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_11497_EMEA SYN LANDING PAGE_Chronic Nerve Pain_BG_AW_October 2022_Bulgarian | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_Neuropathic Pain-BG_1-PG GP LEAFLET-4NOV2022 | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_Neuropathic Pain-BG_1-PG PATIENT LEAFLET-4NOV2022 | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_Neuropathic Pain-BG_2-PG PATIENT LEAFLET-4NOV2022 | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_Neuropathic Pain-DOCTOR EMAIL_BG_EN_v1_4NOV2022 | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_Neuropathic Pain-Patient EMAIL_BG_EN_v1_4NOV2022 | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_S11497_BG_AW_Social Video Slides_Campaign 1_EN_22NOV2022 | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_BGR_S11497_BG_AW_Social Video Slides_Campaign 2_EN_22NOV2022 2 | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_Banners_DE_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_Carousel_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_DE_AW_Social Images_DE_redacted_s | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_DOCTOR EMAIL_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_Email_Banner_DE_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA ADVERTORIAL_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA CAROUSEL AD_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA EMAIL _DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA FOLLOW-UP EMAIL _DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA KEYWORD SEARCH_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA POSTER_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA PRINT AND BANNER_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA RADIO ADS_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA SMS_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA SOCIAL MEDIA_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA SOCIAL VIDEO_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_EMEA SYN LANDING PAGE_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_Neuropathic Pain-DE_1-PG GP LEAFLET_redacted_s | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_Neuropathic Pain-DE_1-PG PATIENT LEAFLET_redacted_s | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_Neuropathic Pain-DE_2-PG PATIENT LEAFLET_redacted_s | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_PaiNT_Ad1_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_PaiNT_Ad2_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_Patient EMAIL_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_Poster_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DE_Recruitment material_Print Ads_DE_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_DEU_Recruitment material_poster | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_ES_Recruitment material_PaiNT_Ad1_ES_pub | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_ES_Recruitment material_PaiNT_Ad2_ES_pub | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_1-PG PATIENT LEAFLET_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_2-PG PATIENT LEAFLET_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_AW_Brand Social_Carousel_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_AW_Brand Social_Images_HU_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_BRAND BANNER AD_AW_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_Brand Banner Ad_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_BRAND SM CAROUSEL_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_BRAND SOCIAL MEDIA_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_EMEA EMAIL _HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_EMEA FOLLOW-UP EMAIL 1_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_EMEA PRINT_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_EMEA RADIO ADS_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_PaiNT_Ad1_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_HU_Recruitment material_PaiNT_Ad2_HU_redacted_S | 2 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_PL_Recruitment material_PaiNT_Ad1_PL_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_2022-501461-52-00_PL_Recruitment material_PaiNT_Ad2_PL_redacted_S | 1 |
| Recruitment arrangements (for publication) | K2_BG-BG_Recruitment material_Merz_Optional wording | 1 |
| Recruitment arrangements (for publication) | K2_BG-BG_Recruitment material_Merz_Poster for special patient | 1.0 |
| Recruitment arrangements (for publication) | K2_BG-EN_Recruitment material_Merz_Optional wording | 1 |
| Recruitment arrangements (for publication) | K2_BG-EN_Recruitment material_Merz_Poster for special patient | 1 |
| Recruitment arrangements (for publication) | K2_DE-DE_Recruitment material_AES_EMEA email_For publication | NA |
| Recruitment arrangements (for publication) | K2_DE-DE_Recruitment material_AES_EMEA Radio_For publication | 2.0 |
| Recruitment arrangements (for publication) | K2_DE-DE_Recruitment material_AES_FOV_For publication | 4.0 |
| Recruitment arrangements (for publication) | K2_DE-DE_Recruitment material_Merz Optional wording V1_12Sep2024 | 1 |
| Recruitment arrangements (for publication) | K2_DE-DE_Recruitment material_Merz Poster for special patient V1_12Sep2024 | 1 |
| Recruitment arrangements (for publication) | K2_ES-ES_Recruitment material_Merz_Optional wording | 1 |
| Recruitment arrangements (for publication) | K2_ES-ES_Recruitment material_Merz_Poster for special patient | 1 |
| Recruitment arrangements (for publication) | K2_HU-HU_Recruitment material_Merz_Poster for special patient | 2.0 |
| Recruitment arrangements (for publication) | K2_HU-HU_Recruitment material_Merz_Poster for special patient_TC | 2.0 |
| Recruitment arrangements (for publication) | K2_PL-PL_Recruitment material_AES_FOV_For publication | 4.0 |
| Recruitment arrangements (for publication) | K2_PL-PL_Recruitment material_Merz_Optional wording_For publication | 1 |
| Recruitment arrangements (for publication) | K2_PL-PL_Recruitment material_Merz_Poster for special patient_For publication | 1 |
| Recruitment arrangements (for publication) | K3_2022-501461-52-00_BG_Recruitment material_Checklist_BG_redacted_S | 1 |
| Recruitment arrangements (for publication) | K3_2022-501461-52-00_BG_Recruitment material_Prescreening Strategy_BG_redacted_S | 1 |
| Recruitment arrangements (for publication) | K3_2022-501461-52-00_DE_Recruitment material_Checklist_DE_redacted_S | 1 |
| Recruitment arrangements (for publication) | K3_2022-501461-52-00_DEU_Recruitment material_prescreening strategy | 1 |
| Recruitment arrangements (for publication) | K3_2022-501461-52-00_HU_Recruitment material_Checklist_HU_redacted_S | 1 |
| Recruitment arrangements (for publication) | K3_2022-501461-52-00_HU_Recruitment material_Prescreening Strategy_HU_redacted_S | 1 |
| Recruitment arrangements (for publication) | K3_2022-501461-52-00_PL_Recruitment material_FOV Checklist_PL_redacted_S | 1 |
| Recruitment arrangements (for publication) | K3_2022-501461-52-00_PL_Recruitment material_Prescreening Strategy_PL_redacted_S | 1 |
| Recruitment arrangements (for publication) | Neuropathic Pain-DE_1-PG GP LEAFLET-4NOV2022 | 1 |
| Recruitment arrangements (for publication) | Neuropathic Pain-DE_1-PG PATIENT LEAFLET-4NOV2022 | 1 |
| Recruitment arrangements (for publication) | Neuropathic Pain-DE_2-PG PATIENT LEAFLET-4NOV2022 | 1 |
| Recruitment arrangements (for publication) | Neuropathic Pain-DOCTOR EMAIL_DE_EN_v1_4NOV2022_German | 1 |
| Recruitment arrangements (for publication) | Neuropathic Pain-Patient EMAIL_DE_EN_v1_4NOV2022_German | 1 |
| Recruitment arrangements (for publication) | Neuropathic Pain-PL_1-PG GP LEAFLET_Redacted | 1 |
| Recruitment arrangements (for publication) | Neuropathic Pain-PL_1-PG PATIENT LEAFLET_Redacted | 1 |
| Recruitment arrangements (for publication) | Neuropathic Pain-PL_2-PG PATIENT LEAFLET_Redacted | 1 |
| Recruitment arrangements (for publication) | S11497_DE_AW_Carousel_EN_15NOV2022 | 1 |
| Recruitment arrangements (for publication) | S11497_DE_AW_Email_Banner_EN_15NOV2022 | 2 |
| Recruitment arrangements (for publication) | S11497_DE_AW_Social Video Slides_Campaign 1_EN_22NOV2022 | 1 |
| Recruitment arrangements (for publication) | S11497_DE_AW_Social Video Slides_Campaign 2_EN_22NOV2022 | 1 |
| Recruitment arrangements (for publication) | S11497_PL_AW_Banners_PL_Reduced_Redacted | 2 |
| Recruitment arrangements (for publication) | S11497_PL_AW_Carousel_PL_Reduced_Redacted | 1 |
| Recruitment arrangements (for publication) | S11497_PL_AW_Email_Banner_PL_Reduced_Redacted | 2 |
| Recruitment arrangements (for publication) | S11497_PL_AW_Poster_PL_Reduced_Redacted | 1 |
| Recruitment arrangements (for publication) | S11497_PL_AW_Print Ads_PL_Reduced_Redacted | 2 |
| Recruitment arrangements (for publication) | S11497_PL_AW_Social Images_PL_Reduced_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_BG_3590002_ICF_Main_BG | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_BG_3590003_ICF_Main_BG | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_BG_3590004_ICF_Main_BG | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_BG_3590005_ICF_Main_BG | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_BG_3590006_ICF_Main_BG | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_BG_ICF_Main_BG | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_BG_ICF_Main_ENG | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_DEU_ICF | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_ESP_ICF_Main | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_HUN_ICF_Data Processing | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_HUN_ICF_pub | 2 |
| Subject information and informed consent form (for publication) | L1_2022-501461-52-00_POL_ICF_Polish | 2 |
| Subject information and informed consent form (for publication) | L2_ 2022-501461-52-00_ESP_ Patient card_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_BGR_Patient card_V1_08Nov2022_BG | 2 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_BGR_Patient card_V1_08Nov2022_ENG | 2 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_DEU_Patient Card | 1 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_HUN_Patient card | 1 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_PL_Other subject information material_Letter to LtFU Patient_EN_redacted_S | 1 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_PL_Other subject information material_Letter to LtFU Patient_PL_redacted_S | 1 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_PL_Other subject information material_Medical Certificate_EN_redacted_S | 1 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_PL_Other subject information material_Medical Certificate_PL_redacted_S | 1 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_PL_Other subject information material_Treatment Assignment Letter_EN_redacted_S | 1 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_PL_Other subject information material_Treatment Assignment Letter_PL_redacted_S | 1 |
| Subject information and informed consent form (for publication) | L2_2022-501461-52-00_POL_Patient_Card_v1_16Nov2022_inPolish | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Xeomin | 35 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BG_2022-501461-52-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2022-501461-52-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2022-501461-52-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2022-501461-52-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2022-501461-52-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU_2022-501461-52-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2022-501461-52-00 | 2 |
Application history
19 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-30 | Germany | Acceptable 2023-04-18
|
2023-04-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-07-13 | Germany | Acceptable 2023-09-07
|
2023-09-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-05 | Acceptable 2023-09-07
|
2023-10-05 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-09 | Acceptable | 2023-11-15 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-03-25 | Germany | Acceptable | 2024-03-25 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-05-13 | Germany | Acceptable | 2024-05-13 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-06-10 | Acceptable | 2024-08-26 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-08-29 | Germany | 2024-08-29 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-10-01 | Acceptable | 2024-11-13 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-10-01 | Germany | Acceptable | 2024-10-11 |
| 11 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-02 | Acceptable | 2024-11-15 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-02 | Acceptable | 2025-01-09 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-10-02 | Acceptable | 2024-12-11 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-12-10 | Germany | Acceptable | 2024-12-20 |
| 15 | SUBSTANTIAL MODIFICATION | SM-13 | 2024-12-10 | Acceptable | 2025-02-03 | |
| 16 | SUBSTANTIAL MODIFICATION | SM-14 | 2024-12-10 | Acceptable | 2025-03-10 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-12-11 | Acceptable | 2025-01-31 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-15 | 2024-12-12 | Acceptable | 2025-01-30 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-03-21 | Germany | 2025-03-21 |