Phase 2
N=112
Almorexant (ACT-078573) in Elderly Subjects With Chronic Primary Insomnia
Chronic Primary Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT00606593 ↗Enrolled (actual)
112
Serious AEs
0.2%
Results posted
Mar 2013
Primary outcome: Primary: Mean Wake Time After Sleep Onset (WASO) — 109.1; 98.7; 90.0; 77.7 minutes — p=0.0018
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ACT-078573 oral capsules at 25 and 100 mg and matching placebo (Drug); ACT-078573 and matching placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Midnight Pharma, LLC
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Wake Time After Sleep Onset (WASO) |
109.1; 98.7; 90.0; 77.7; 62.6 | 0.0018 sig |
| SECONDARY Mean Total Sleep Time (TST) |
339.7; 353.8; 360.9; 374.2; 394.7 | <0.0001 sig |
Summary
A 2-night polysomnography / 5-way cross-over study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in elderly subjects with primary insomnia.
Eligibility Criteria
Inclusion Criteria
- Elderly subjects (> 64 years) with a diagnosis of primary insomnia.
Exclusion Criteria
- History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) axis I disorder other than primary insomnia.
- Sleep apnea, or restless legs syndrome.
- Daytime napping of more than 1 hour per day.
- Important caffeine consumption, heavy tobacco use, alcohol or drug abuse within 2 years prior to the screening visit.
- Unwillingness to refrain from drugs, over-the-counter or herbal medication having an effect on sleep or behavior.
Data sourced from ClinicalTrials.gov (NCT00606593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.