Multi-center, double-blind, randomized, placebo-controlled, active reference, parallel-group polysomnography study to assess the efficacy and safety of a 16-day oral administration of ACT-078573 in adult subjects with chronic primary insomnia - RESTORA 1

• Conditions: Chronic primary insomnia; MedDRA version: 9.1Level: LLTClassification code 10022437Term: Insomnia

• Registration Number: EUCTR2007-005194-56-IT
• Lead Sponsor: Actelion Pharmaceuticals Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-25
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 668

Inclusion Criteria

Primary insomnia by DSM-IV-TR criteria.
Self-reported history of the following for at least 3 months priorto the screening visit:− Usual time to fall asleep ≥ 30 min− Usual wake time during sleep ≥ 30 min− Usual total sleep time < 6.5 h.confirmed on at least 3 nights (out of 7 consecutive nights prior to Visit 2) on the screening Sleep Diary.
Usual bedtime between 20:30 and 00:30confirmed on at least 5 nights (out of 7 consecutive nights prior toVisit 2) on the screening Sleep Diary.
Mean LPS ≥ 20 min (with no night < 15 min), mean WASO ≥ 20 min (with no night < 15 min), and mean TST < 420 min on the 2 PSG screening nights.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History of any sleep disorder other than primary insomnia.
- Any axis-I disorder other than primary insomnia according to the DSM-IV criteria within 6 months prior to the screening visit.
- Apnea / hypopnea index (AHI) ≥ 10/h on the first PSG screening night.
- Apnea or hypopnea event associated with oxygen saturation by pulse oximetry (SpO2) < 80%, on the first PSG screening night.
- Periodic limb movement arousal index (PLMAI) ≥ 10/h on the first PSG screening night.
- Pregnancy or breast-feeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate the effect of oral administration of ACT-078573 200 mg vs placebo on latency to persistent sleep (LPS) and/or wake after sleep onset (WASO) as determined by polysomnography (PSG).;Secondary Objective: - To demonstrate the effect of oral administration of ACT-078573 100 mg vs placebo on LPS and/or WASO, as determined by PSG.- To demonstrate the effect of oral administration of ACT-078573 at doses of 200 and/or 100 mg vs placebo on self-reported time to fall asleep (sLPS) and/or on self-reported wake time during sleep (sWASO).- To evaluate the safety and tolerability of a 16-day oral administration of ACT-078573 at doses of 200 and 100 mg;Primary end point(s): - Change from baseline to Day 1&2 in latency to persistent sleep (LPS).<br>- Change from baseline to Day 1&2 in wake after sleep onset (WASO).