Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
50
Countries
2
Sites
13
Insomnia Disorder
To assess whether daridorexant improves insomnia in subjects with insomnia and comorbid nocturia.
Key facts
- Sponsor
- Idorsia Pharmaceuticals Ltd., Idorsia Pharmaceuticals Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 8 Mar 2023 → 18 Apr 2024
- Decision date (initial)
- 2023-03-02
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Idorsia Pharmaceuticals Ltd
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess whether daridorexant improves insomnia in subjects with insomnia and comorbid nocturia.
Secondary objectives 1
- To assess the efficacy of daridorexant on nocturia.
Conditions and MedDRA coding
Insomnia Disorder
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10029446 | Nocturia | 100000004857 |
| 20.0 | PT | 10022437 | Insomnia | 100000004873 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment Period 1 The double-blind cross-over phase will consist of 2 treatment periods. The double-blind treatment period 1 lasts 29 days.
|
Randomised Controlled | Double | [{"id":24921,"code":1,"name":"Subject"},{"id":24920,"code":3,"name":"Monitor"},{"id":24922,"code":4,"name":"Analyst"},{"id":24923,"code":2,"name":"Investigator"}] | Daridorexant 50 mg: Daridorexant is available as oral film-coated tablets at a strength of 50 mg and will be taken orally, once daily in the evening within approximately 30 min before going to bed. Placebo: Daridorexant-matching placebo is provided as identically looking oral tablets and will be taken orally, once daily in the evening within approximately 30 min before going to bed. |
| 2 | Treatment Period 2 Treatment period 2 is separated from treatment period 1 by a washout period of 14–21 days.
The double-blind treatment period 2 lasts 29 days.
|
Randomised Controlled | Double | [{"id":24928,"code":4,"name":"Analyst"},{"id":24925,"code":1,"name":"Subject"},{"id":24927,"code":3,"name":"Monitor"},{"id":24926,"code":2,"name":"Investigator"}] | Daridorexant 50 mg: Daridorexant is available as oral film-coated tablets at a strength of 50 mg and will be taken orally, once daily in the evening within approximately 30 min before going to bed. Placebo: Daridorexant-matching placebo is provided as identically looking oral tablets and will be taken orally, once daily in the evening within approximately 30 min before going to bed. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Signed and dated ICF prior to any study-mandated procedure.
- Male or female subjects ≥ 55 years old at the time of signing the ICF.
- Insomnia complaints for at least 3 months prior to Visit 1.
- ISI© score ≥ 13 at Visit 1.
- Nocturia severity: on average ≥ 3 nocturnal voids per night reported by the subjects for at least 1 month prior to Visit 1.
- Ability to communicate well with the investigator, to understand the study requirements and judged by the investigator to be alert and oriented to person, place, time, and situation.
Exclusion criteria 9
- Woman of childbearing potential, pregnant or plans to become pregnant.
- Planned travel across ≥ 3 time zones during study.
- Life time history of suicidality assessed via C-SSRS©.
- Regular caffeine consumption after 4 pm.
- Unable to refrain from smoking during the night.
- Known and documented diagnosis of narcolepsy, periodic limb movement disorder, moderate to severe obstructive sleep apnea, restless legs syndrome, circadian rhythm sleep-wake disorder, or REM sleep behavior disorder.
- Known and documented diagnosis of Type 1 diabetes mellitus, uncontrolled Type 2 diabetes mellitus, and central or nephrogenic diabetes insipidus, and primary/secondary polydipsia within the last 6 months prior to Visit 1.
- Known and documented nocturia linked to urinary tract infection, neoplasms of bladder, prostate or urethral cancer, bladder or urethral calculi, or neurogenic voiding dysfunction within the last 6 months prior to Visit 1.
- Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from baseline to Week 4 in subjective total sleep time (sTST).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
QUVIVIQ 50 mg film-coated tablets
PRD9668426 · Product
- Active substance
- Daridorexant
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 1450 mg milligram(s)
- Max treatment duration
- 29 Day(s)
- Authorisation status
- Authorised
- ATC code
- NOT ASS — -
- Marketing authorisation
- EU/1/22/1638/004
- MA holder
- IDORSIA PHARMACEUTICALS DEUTSCHLAND GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Primary and secondary packaging are modified and the tablets do not present any debossing.
Placebo 1
daridorexant placebo matching film-coated tablets
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
Idorsia Pharmaceuticals Ltd.
- Sponsor organisation
- Idorsia Pharmaceuticals Ltd.
- Address
- Hegenheimermattweg 91
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Scientific contact point
- Organisation
- Idorsia Pharmaceuticals Ltd.
- Contact name
- Idorsia Clinical Trial Information
Public contact point
- Organisation
- Idorsia Pharmaceuticals Ltd.
- Contact name
- Idorsia Clinical Trial Information
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Yprime LLC ORG-100042888
|
Malvern, United States | E-data capture |
| Flying Study Team GbR ORG-100043927
|
Freiburg Im Breisgau, Germany | On site monitoring |
| Competence In Scientific Services Eggenreich & Gschanes GmbH ORG-100042988
|
Graz, Austria | Code 12, Code 8 |
| DATAMAP-Gesellschaft Fur Datenmanagement, Datenanalyse Und Datenprasentation mbH ORG-100042869
|
Freiburg Im Breisgau, Germany | Code 10 |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Minze ORG-100043187
|
Antwerp, Belgium | E-data capture |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Other |
| Precision For Medicine (HU) Kft. ORG-100040390
|
Budapest XII, Hungary | On site monitoring, Code 12, Code 2, Code 8 |
Idorsia Pharmaceuticals Ltd.
- Sponsor organisation
- Idorsia Pharmaceuticals Ltd.
- Address
- Hegenheimermattweg 91
- City
- Allschwil
- Postcode
- 4123
- Country
- Switzerland
Locations
2 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 9 | 5 |
| Spain | Ended | 26 | 8 |
| Rest of world
United States
|
— | 15 | — |
Investigational sites
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH
SOMNIBENE Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH, Goethestrasse 1, Feldstadt, Schwerin
Advanced Sleep Research GmbH
Advanced Sleep Research GmbH, Luisenstrasse 54-55, Mitte, Berlin
Urologische Praxisgemeinschaft - Praxisklinik am Franziskushospital
Urologische Praxisklinik am Franziskushospital, Sanatoriumstraße 10, 52064, Aachen
Gemeinschaftspraxis Michael Berse & Hans Schippel
Gemeinschaftspraxis Michael Berse & Hans Schippel, Königstraße 49, 47051, Duisburg
Urologicum Duisburg
Urologicum Duisburg, Fahrner Str 123, 47169, Duisburg
University Hospital Of Canary Islands
Urology, Carretera Cuesta Taco S/N, 38320, San Cristobal De La Laguna
Hospital Del Mar
Urology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Uroclinica Barcelona SLP
Urology, Via Augusta 158 4a 3, 08006, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Urology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario La Paz
Urology, Paseo Castellana 261, 28046, Madrid
Hospital Universitario Puerta Del Mar
Urology, Avenida De Ana De Viya 21, 11009, Cadiz
Hospital Universitario Central De Asturias
Urology, Avenida De Roma S/n, 33011, Oviedo
Complexo Hospitalario Universitario A Coruna
Urology, Lugar Jubias De Arriba 84, 15006, A Coruna
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 |
|---|---|---|---|---|---|
| Germany | 2023-04-03 | 2024-04-17 | 2023-08-17 | 2024-01-19 | |
| Spain | 2023-03-08 | 2024-01-25 | 2023-04-14 | 2024-01-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2022-501246-30 - Summary of results SUM-79025
|
2025-04-14T10:23:13 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| 2022-501246-30 - Lay person summary of results | 2025-04-14T10:23:24 | Submitted | Laypersons Summary of Results |
| 2022-501246-30 - Lay person summary of results_DE | 2025-06-12T09:48:05 | Submitted | Laypersons Summary of Results |
| 2022-501246-30 - Lay person summary of results_ES | 2025-06-12T09:47:58 | Submitted | Laypersons Summary of Results |
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 2022-501246-30 - Lay person summary of results | 1 |
| Laypersons summary of results (for publication) | 2022-501246-30 - Lay person summary of results_DE | 1 |
| Laypersons summary of results (for publication) | 2022-501246-30 - Lay person summary of results_ES | 1 |
| Summary of results (for publication) | 2022-501246-30 - Summary of results | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-10-26 | Germany | Acceptable 2023-02-27
|
2023-03-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-04-28 | Germany | Acceptable 2023-05-09
|
2023-05-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-6 | 2023-09-29 | Germany | Acceptable 2023-11-27
|
2023-11-29 |