Study to assess the efficacy and safety of ACT-541468 in adult and elderly subjects suffering from difficulties to sleep

• Register: EUCTR
• Last refreshed on: 8 June 2020
• Main ID: EUCTR2017-004643-20-FI
• Date of registration: 14/05/2018
• Prospective Registration: Yes
• Primary sponsor: Idorsia Pharmaceuticals Ltd
• Public title: Study to assess the efficacy and safety of ACT-541468 in adult and elderly subjects suffering from difficulties to sleep
• Scientific title: Multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography study to assess the efficacy and safety of ACT-541468 in adult and elderly subjects with insomnia disorder
• Date of first enrolment: 17/05/2018
• Target sample size: 900
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004643-20
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Hungary, Sweden, United States

Contacts

• Name: Clinical Trial Disclosure Desk
• Affiliation: Idorsia Pharmaceuticals Ltd

• Name: Clinical Trial Disclosure Desk
• Affiliation: Idorsia Pharmaceuticals Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- Signed informed consent prior to any study-mandated procedure;
- Male or female aged = 18 years;
- Insomnia disorder according to DSM-5 criteria;
- Insomnia Severity Index score = 15;
- Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography;
- Women of childbearing potential must have a negative and urine pregnancy test and use the contraception scheme up to at least 30 days after last study treatment intake.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 540
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 360

Exclusion criteria:
- Body mass index below 18.5 or above 40.0 kg/m2;
- Any lifetime history of of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, narcolepsy, or apnea/hypopnea;
- Cognitive behavioral therapy (CBT) for any indication is allowed, only, if CBT started at least 1 month prior to Visit 3 and the subject agrees to continue this CBT throughout the study;
- Self-reported usual daytime napping = 1 hour per day and = 3 days per week;
- Acute or unstable psychiatric conditions diagnosed by the Mini International Neuropsychiatric Interview;
- Mini Mental State Examination (MMSE) score < 25 in subjects = 50 years;
- For female subjects: pregnant, lactating or planning to become pregnant during projected duration of the study;
- History or clinical evidence of any disease or medical condition or
treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Insomnia disorder
MedDRA version: 20.0 Level: PT Classification code 10022437 Term: Insomnia System Organ Class: 10037175 - Psychiatric disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: -
Product Code: ACT-541468
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: -
Current Sponsor code: ACT-541468
Other descriptive name: ACT-541468
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: -
Product Code: ACT-541468
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: -
Current Sponsor code: ACT-541468
Other descriptive name: ACT-541468
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. From baseline to Month 1;
2. From baseline to Month 3;
3. From baseline to Month 1;
4. From baseline to Month 3.

Primary end point(s): 1. The change from baseline to Month 1 in Wake After Sleep Onset (WASO) (sleep maintenance);
2. The change from baseline to Month 3 in Wake After Sleep Onset (WASO);
3. The change from baseline to Month 1 in Latency to Persistent Sleep (LPS) (sleep onset);
4. The change from baseline to Month 3 in Latency to Persistent Sleep (LPS).

Main Objective: To evaluate the efficacy of 10 mg and 25 mg ACT-541468 on objective sleep parameters in subjects with insomnia disorder.

Secondary Objective: - To evaluate the efficacy of 10 mg and 25 mg ACT-541468 on subjective sleep parameters and next-day functioning in subjects with insomnia disorder;
- To assess the safety and tolerability of ACT-541468 in subjects with insomnia disorder during treatment and upon treatment discontinuation.

Secondary Outcome(s)

Secondary end point(s): 1. The change from baseline to Month 1 in the subjective Total Sleep Time (sTST);
2. The change from baseline to Month 3 in the subjective Total Sleep Time (sTST);
3. The change from baseline to Month 1 in Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) sleepiness domain score;
4. The change from baseline to Month 3 in IDSIQ sleepiness domain score.

Timepoint(s) of evaluation of this end point: 1. From baseline to Month 1;
2. From baseline to Month 3;
3. From baseline to Month 1;
4. From baseline to Month 3.

Secondary ID(s)

ID-078A302

2017-004643-20-BG

Source(s) of Monetary Support

Idorsia Pharmaceuticals Ltd

Ethics review

Status: Approved
Approval date: 21/03/2018
Contact: