Phase 3 N=707 Randomized Quadruple-blind Treatment

Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia

Primary Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT00608985 ↗

Enrolled (actual)

707

Serious AEs

0.4%

Results posted

Feb 2013

Primary outcome: Primary: Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO) — 85.0; 86.6; 92.3; 76.5 minutes — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: almorexant (Drug); Placebo (Drug); zolpidem (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Midnight Pharma, LLC
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Day 1&2 in Wake After Sleep Onset (WASO)	85.0; 86.6; 92.3; 76.5; 72.8; 54.5	<0.0001 sig
PRIMARY Change From Baseline to Day 15&16 in WASO	85.0; 86.6; 92.3; 76.5; 65.0; 55.8	0.0001 sig
PRIMARY Change From Baseline to Week 1&2 in the Self-reported WASO (sWASO)	64.0; 65.0; 69.0; 61.6; 52.9; 40.5	0.0186 sig
SECONDARY Change From Baseline to Day 1&2 in Latency to Persistent Sleep (LPS)	57.3; 57.4; 54.1; 56.5; 37.5; 28.8	0.0035 sig
SECONDARY Change From Baseline to Day 15&16 in LPS	57.3; 57.4; 54.1; 56.5; 30.0; 29.3	0.2237
SECONDARY Change From Baseline to Week 1&2 in Subjective Latency to Sleep Onset (sLSO)	58.8; 55.0; 53.3; 50.5; 45.0; 36.5	0.1187

Summary

A polysomnography study to evaluate the effect, safety and tolerability of oral administration of almorexant (ACT 078573) in adult subjects with primary insomnia.

Eligibility Criteria

Inclusion Criteria

Adult subjects (18-64 years) with a diagnosis of primary insomnia.

Exclusion Criteria

History of any sleep disorder, or any Diagnostic and Statistical Manual of Mental Disorders, 4th edition (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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00608985). 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.