Clinical trial NCT02353299
Conditions: Healthy
Keywords: Cognition Balance
Sponsor: Currax Pharmaceuticals
Start date: 2015-01-01; Completion date: 2016-03-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase IV, randomized, double-blind, placebo-controlled, four-arm crossover study. The study will assess the effects of a single dose of Silenor 6 mg compared with matching placebo and a single dose of zolpidem 10 mg compared to its matching placebo at the respective T-max in normal healthy adult male volunteers. The study will be conducted in approximately 52 male subjects

Detailed description:
Subjects will be screened and asked to complete sleep disorders questionnaires and a sleep diary to establish normal sleep patterns and to rule out any sleep disorder.

Eligible subjects will be scheduled for a Screening PSG to rule out PLMS, sleep apnea and other sleep disorders.

Subjects who meet the screening PSG criteria will be randomly assigned to a treatment sequence order that involves both the study drug and the time subjects are awakened in the middle-of-the-night using a crossover study design. These four sequences include Silenor 6 mg with a middle-of-the-night awakening at 4 hours (DXP-4H), zolpidem 10 mg with a middle-of-the-night awakening at 1.5 hours (ZOL-1.5H), placebo with a middle-of-the-night awakening at 4 hours (PBO-4H), and placebo with a middle-of-the-night awakening at 1.5 hours (PBO-1.5H). Study drug will be administered under fasted conditions (at least 4 hours) as a single dose at bedtime (approximately 2300 hours), and each subject will receive one dose of each active drug (Silenor 6 mg and zolpidem 10 mg), and two doses of placebo during the treatment period.

Safety assessments will be performed throughout the study.

During the night of assessment, subjects will be awoken at the estimated T-max of the active drugs, with a matching placebo group awakened at each of these time points with the same arousability protocol. Arousability will be assessed using the Auditory Awakening Threshold test (AAT) .

Once the Auditory Awakening Threshold has been determined, subjects will perform a Tandem Walk assessment followed by the Berg Balance Scale (BBS) and finally by Free Recall Memory testing.

Subjects will be discharged from the sleep center once all assessments have been completed. A final study visit will be performed for subjects either after they have completed all four Treatment Periods or they have prematurely discontinued the study.

Arms: arm 1: Silenor 6 mg single nightime dose- 4 hour post dose arousability and cognitive assessments arm 2: placebo single nightime dose -4 hour post dose arousability and cognitive assessments arm 3: zolpidem 10 mg single nightime dose - 1.5 hour arousability and cognitive assessments arm 4: placebo single nightime dose -1.5 hour arousability and cognitive assessments
Interventions: intervention 1: Silenor 6 mg intervention 2: zolpidem 10 mg intervention 3: Placebo intervention 4: Placebo
Intervention descriptions: intervention 1: Silenor 6 mg single nighttime dose. intervention 2: Zolpidem 10 mg single nighttime dose intervention 3: placebo single nighttime dose-1.5 hours intervention 4: placebo single nighttime dose-4 hours

Protocol documents: