Withdrawal Study to Demonstrate the Maintenance Effect in the Treatment of Non-24-Hour Sleep-Wake Disorder
The purpose of this study is to evaluate the maintenance effect and safety of 20 mg tasimelteon versus placebo in subjects suffering from Non-24-Hour Sleep-Wake Disorder.
Non-24-Hour Sleep-Wake Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Withdrawal Study to Demonstrate the Maintenance of Effect of 20 mg Tasimelteon in the Treatment of N24HSWD|
- Maintenance of circadian rhythm entrainment in subjects with N24HSWD. [ Time Frame: Approximately 12 weeks ] [ Designated as safety issue: No ]
- Symptoms of withdrawal after a minimum of three months of tasimelteon treatment assessed by the Benzodiazepine Withdrawal Symptom Questionnaire. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
- Number of participants with Treatment-Emergent Adverse Events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Treatment-emergent adverse events (TEAEs) will be summarized by treatment group, by presenting, for each treatment group, the number and percentage of subjects having any treatment-emergent AE, having an AE in each body system, and having each individual AE.
- Number of participants with changes in Clinical Laboratory Data [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Standard Serum Hematology and Chemistry tests will be performed at basline and throughout the study
- Number of participants with newly occurring or worsening ECG abnormalities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of participants with clinically notable values for Vital Signs and Body Measurements [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of participants who report a positive result for the C-SSRS [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
20 mg tasimelteon capsules
20 mg tasimelteon capsules, daily
Other Name: VEC-162
Placebo Comparator: Placebo
Placebo capsules, daily
Non-24-Hour Sleep-Wake Disorder (N24HSWD) occurs when individuals are unable to synchronize their endogenous circadian pacemaker to the 24-hour light-dark cycle, and the timing of their circadian rhythm instead reflects the intrinsic period of their endogenous circadian pacemaker. As a result, the circadian rhythm of sleep-wake propensity in these individuals moves gradually later and later each day if there circadian period is > 24 hours and earlier and earlier is < 24 hours. These individuals will be able to sleep well at night when their sleep-wake propensity rhythm is approximately aligned with the 24-hour light-dark and social cycle. However, after a short time, the endogenous sleep-wake propensity rhythm and the 24-hour light-dark cycle will move out of synchrony with each other, and they may have difficulty falling asleep until well into the night. In addition to problems sleeping at the desired time, the subjects experience daytime sleepiness and daytime napping. As time progresses, the endogenous circadian rhythm of sleep-wake propensity in these individuals moves further and further away from the 24-hour light-dark cycle and gradually, these individuals are unable to sleep at night and as a result experience extreme sleepiness during the daytime hours and more frequent naps with a longer duration. Eventually, the sleep-wake time moves back into alignment with the social time for sleep and the individuals sleep well at night and have decreased daytime napping. The alignment between their endogenous circadian rhythms and the 24-hour day is temporary as they are continually drifting later and later each day.
This will be a multicenter, randomized withdrawal, double-masked, placebo-controlled, parallel study. The study has three phases: the tasimelteon run-in phase, the tau estimation phase, and the randomized withdrawal phase. Subjects who have participated in study VP-VEC-162-3201 that meet the entry criteria for this study will be eligible for the run-in phase The run-in phase comprises a screening visit where subject's initial eligibility will be evaluated. Subjects that meet the inclusion/exclusion criteria at screening will enter the run-in phase and will be dosed with 20 mg of tasimelteon daily for 6 weeks. The tau estimation phase (48 hour urine collection samples to evaluate response to tasimelteon) will follow the run-in phase and will last approximately 6 weeks long. The randomized withdrawal phase comprises approximately eight weeks of treatment with either placebo or tasimelteon 20 mg taken approximately 1 hour prior to their target bedtime in a double-masked fashion.
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|Study Director:||Vanda Pharmaceuticals||Vanda Pharmaceuticals|