Study:
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
Rationale:
n/a
Purpose:
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 Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Chronic Primary Insomnia |
Drug: ACT-078573 oral capsules at 25 and 100 mg and matching placebo Drug: ACT-078573 and matching placebo Drug: ACT-078573 and matching placebo Drug: ACT-078573 and matching placebo Drug: ACT-078573 and matching placebo Drug: ACT-078573 and matching placebo Drug: ACT-078573 and matching placebo Drug: ACT-078573 and matching placebo Drug: ACT-078573 and matching placebo Drug: ACT-078573 and matching placebo |
Phase 2 |
Verified by
Actelion
February, 2013
Sponsored by: Actelion
Information provided by: Actelion
ClinicalTrials.gov identifier: NCT00606593
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic Health Systems
Cleveland, Ohio 44195
United States
James K. Walsh, PhD., Principal Investigator