CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
ACT-078573 oral capsules at 25 and 100 mg and matching placebo +9 moredrug
Likely dose
ACT-078573 oral capsules at 25 and 100 mg and matching placebofrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00606593
NCT00606593Phase 2Completed
CompareCT.gov

Multicenter, Double-blind, Randomized, Placebo-controlled, 5-period, 5-treatment Crossover, Dose-finding Study to Evaluate the Efficacy and Safety of Oral Administration of ACT-078573 in Elderly Subjects With Chronic Primary Insomnia

Midnight Pharma, LLC·interventional·Posted Feb 4, 2008·Updated Mar 14, 2016

In Brief

A Phase 2 clinical trial evaluating ACT-078573 oral capsules at 25 and 100 mg and matching placebo and ACT-078573 and matching placebo for Chronic Primary Insomnia. Completed, enrolled 112 participants across 21 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Primary Insomnia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 4, 2008
Enrollment StartDec 1, 2007
Primary CompletionApr 1, 2008
Study CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.4 years ago

Interventions

ACT-078573 oral capsules at 25 and 100 mg and matching placebodrug

5-period, 5-treatment crossover: sequences: ABECD, BCADE, CDBEA, DECAB, EADBC DCEBA, EDACB, AEBDC, BACED, CBDAE Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

ACT-078573 and matching placebodrug

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

ACT-078573 and matching placebodrug

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

ACT-078573 and matching placebodrug

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

ACT-078573 and matching placebodrug

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

ACT-078573 and matching placebodrug

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

ACT-078573 and matching placebodrug

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

ACT-078573 and matching placebodrug

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

ACT-078573 and matching placebodrug

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo

ACT-078573 and matching placebodrug

ACT-078573 oral capsules at 25 and 100 mg and matching placebo 5-period, 5-treatment crossover Where A = 200mg, B = 100 mg, C = 50 mg, D = 25mg, E = Placebo