Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
300
Countries
3
Sites
10
Pain Associated With Diabetic Peripheral Neuropathy
• To evaluate the efficacy of VX-993 doses in treating subjects with pain associated with diabetic peripheral neuropathy (DPN) • To evaluate the safety and tolerability of VX-993
Key facts
- Sponsor
- Vertex Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 12 May 2025 → ongoing
- Decision date (initial)
- 2025-03-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Vertex Pharmaceuticals Incorporated
External identifiers
- EU CT number
- 2024-514689-38-01
- ClinicalTrials.gov
- NCT06619860
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
• To evaluate the efficacy of VX-993 doses in treating subjects with pain associated with diabetic peripheral neuropathy (DPN)
• To evaluate the safety and tolerability of VX-993
Conditions and MedDRA coding
Pain Associated With Diabetic Peripheral Neuropathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10067547 | Diabetic peripheral neuropathic pain | 10029205 |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514689-38-00 | A Phase 2, Randomized, Double-blind, Active-controlled, Dose-ranging, Parallel-design Study of the Efficacy and Safety of Oral VX-993 in Subjects With Painful Diabetic Peripheral Neuropathy | Vertex Pharmaceuticals Inc. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Diagnosis of diabetes mellitus type 1 or type 2 with o glycosylated hemoglobin A1c (HbA1c) ≤9%; o in the opinion of the investigator, optimized glycemic control, and subject has been stable on anti-diabetic medicine/drugs or dietary treatment for ≥3 months before Screening Visit 1; and o presence of bilateral pain in lower extremities due to DPN (defined as a symmetric, length-dependent sensory or sensorimotor polyneuropathy) for at least 1 year.
Exclusion criteria 3
- Painful neuropathy other than DPN, such as post-herpetic neuralgia, post-traumatic nerve injury, diabetic amyotrophy, human immunodeficiency virus (HIV) neuropathy, immune sensory and autonomic polyneuropathy (e.g., Sjogren’s syndrome), hereditary sensory and autonomic polyneuropathy, focal diabetic neuropathies (e.g., proximal motor neuropathy, mononeuropathy, mononeuropathy multiplex), or chronic regional pain syndrome. Previously diagnosed compressive neuropathy (e.g., carpal tunnel syndrome) with symptoms limited to upper extremities that is now resolved is not exclusionary
- Cardiac dysrhythmias requiring anti-arrhythmic treatment(s) within the last 2 years; history or evidence of abnormal study ECGs that in the opinion of the investigator or medical monitor would preclude the subject’s participation in the study; or history of QT prolongation or standard 12-lead ECG (performed in triplicate) demonstrating median QTcF >450 msec at Screening Visit 1; or clinical evidence of structural heart disease.
- History of a clinical atherosclerotic event, such as myocardial infarction or stroke, within the past 12 months before Screening Visit 1.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline in the weekly average of daily pain intensity on the numeric pain rating scale (NPRS) at Week 12
Secondary endpoints 2
- Proportions of subjects with ≥30%, ≥50%, and ≥70% reductions from baseline in the weekly average of daily pain intensity on the NPRS at Week 12
- Safety and tolerability based on adverse events (AEs), laboratory test results, vital signs, and ECGs
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD11328185 · Product
- Active substance
- VX-993
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0.0 mg milligram(s)
- Max total dose
- 0.0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- VERTEX PHARMACEUTICALS, INCORPORATED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11495825 · Product
- Active substance
- VX-993
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0.0 mg milligram(s)
- Max total dose
- 0.0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- VERTEX PHARMACEUTICALS, INCORPORATED
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 2
SUB10023MIG · Substance
- Active substance
- Pregabalin
- Pharmaceutical form
- CAPSULES
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 13 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Pregabalin is encapsulated to maintain the blinding of the study
SUB10023MIG · Substance
- Active substance
- Pregabalin
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 13 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Pregabalin is encapsulated to maintain the blinding of the study
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- ORAL
- Max daily dose
- 0 mg/g milligram(s)/gram
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- This is the placebo for the active comparator (pregabalin). This placebo does not contain any active substance or product
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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vertex Pharmaceuticals Inc.
- Sponsor organisation
- Vertex Pharmaceuticals Inc.
- Address
- 50 Northern Avenue
- City
- Boston
- Postcode
- 02210-1862
- Country
- United States
Scientific contact point
- Organisation
- Vertex Pharmaceuticals Inc.
- Contact name
- Clinical Trials and Medical Info
Public contact point
- Organisation
- Vertex Pharmaceuticals Inc.
- Contact name
- Clinical Trials and Medical Info
Locations
3 EU/EEA countries · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 30 | 5 |
| Germany | Ongoing, recruiting | 18 | 3 |
| Italy | Ongoing, recruiting | 12 | 2 |
| Rest of world
United Kingdom, Canada, United States
|
— | 240 | — |
Investigational sites
Centre Hospitalier Universitaire De Saint Etienne
Centre d'Evaluation et de Traitement de la Douleur (CETD), Avenue Albert Raimond, 42270, Saint Priest En Jarez
Hopital Ambroise Pare
Centre d'Evaluation et de Traitement de la Douleur (CETD), 9 Avenue Charles De Gaulle, 92100, Boulogne Billancourt
Centre Hospitalier Universitaire De Nimes
Centre d'Evaluation et de Traitement de la Douleur (CETD), 4 Place Du Professeur Robert Debre, Bp 40026, Nimes Cedex 9
Assistance Publique Hopitaux De Paris
Centre d'Evaluation et de Traitement de la Douleur (CETD), 27 Rue Du Faubourg Saint Jacques, 75014, Paris
CHU Gabriel-Montpied
Centre d'Evaluation et de Traitement de la Douleur (CETD), 58 Rue Montalembert, 63000, Clermont Ferrand
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Klinik für Diabetologie und Endokrinologie, Georgstrasse 11, Innenstadt, Bad Oeynhausen
FutureMeds GmbH
FutureMeds, Platz Der Deutschen Einheit 4, 63065, Offenbach Am Main
FutureMeds GmbH
FutureMeds, Wilmersdorfer Strasse 79, Charlottenburg, Berlin
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 |
|---|---|---|---|---|---|
| France | 2025-05-22 | 2025-07-08 | |||
| Germany | 2025-05-12 | 2025-05-19 | |||
| Italy | 2025-09-02 | 2025-09-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 71 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_ENG_2024-514689-38-01_Redacted | 5.1 |
| Protocol (for publication) | D4_Patient facing document_C-SSRS-Baseline_EN_for publication | 1/14/09 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-Baseline_DE | 14.01.2009 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-Baseline_FR | 1/14/09 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-Baseline_IT | 1/14/09 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-SinceLastVisit_DE | 14.01.2009 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-SinceLastVisit_EN_for publication | 1/14/09 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-SinceLastVisit_FR | 1/14/09 |
| Protocol (for publication) | D4_Patient facing documents_C-SSRS-SinceLastVisit_IT | 1/14/09 |
| Protocol (for publication) | D4_Patient facing documents_NPRS-Average_DE_for publication | 1 |
| Protocol (for publication) | D4_Patient facing documents_NPRS-Average_EN_for publication | 1 |
| Protocol (for publication) | D4_Patient facing documents_NPRS-Average_FR_for publication | 1 |
| Protocol (for publication) | D4_Patient facing documents_NPRS-Average_IT_for publication | 1 |
| Recruitment arrangements (for publication) | K1_Additional document_France_Fr_redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_France_Fr_redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advertisement copy_IT_it | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advertisement_DE_de | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Fr_fr | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Consent Form_DE_de | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Consent Form_IT_it | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_FutureMeds Berlin_DE_de | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_FutureMeds Offenbach_DE_de | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ICF Tool_DE_de_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ICF Tool_FR_fr_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ICF tool_IT_it_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Images for outreach campaign_DE_de_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Images for outreach campaign_IT_it_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Invitation to trial letter_FR_fr_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Invitation to trial letter_IT_it_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Notes_DE_de | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Notes_IT_it | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Online screener_DE_de | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Online screener_IT_it | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Invitation to Trial Letter_DE_de_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Phone screener_IT_it | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Phone_screener_DE_de | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Doctor Letter_DE_de_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Doctor Letter_IT_it_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PI to Dr_FR_fr_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_DE_de | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Fr_fr | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_IT_it | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad_DE_de | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Print Ad_IT_it | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Printed ad_FR_fr | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_DE_de | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Brochure_IT_it | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Text_FutureMeds Berlin_DE_de | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Text_FutureMeds Offenbach_DE_de | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Fact Sheet_DE_de_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Fact Sheet_FR_fr_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Fact Sheet_IT_it_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum to Adult ICF_France_Fr_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_DE_de_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_France_Fr_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adult_IT_it_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_DE_de | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_France_Fr | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_IT_it | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Suvoda_DE_de | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy Supplement_Adult_IT_it | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy Supplement_Pregnancy IC_IT_it | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Suvoda_IT_it | 2.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter_IT_it_redacted | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Pregabalin capsule | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2024-514689-38-01_Redacted | 5.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2024-514689-38-01_Redacted | 5.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-514689-38-01_Redacted | 5.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2024-514689-38-01_Redacted | 5.1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-26 | Germany | Acceptable with conditions 2025-03-24
|
2025-03-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-08 | Acceptable with conditions 2025-03-24
|
2025-04-08 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-23 | Germany | Acceptable with conditions 2025-03-24
|
2025-07-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-21 | Germany | Acceptable with conditions | 2025-11-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-09 | Germany | Acceptable 2026-02-06
|
2026-02-09 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-12 | Germany | Acceptable 2026-04-21
|
2026-04-21 |