Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia
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|ClinicalTrials.gov Identifier: NCT02671760|
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : March 6, 2018
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Short-term Insomnia||Drug: SM-1 Drug: Comparator Drug: Placebo||Phase 2|
The purpose of this study is to evaluate the effect of a combination drug product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam on total sleep time, and to determine the contribution of diphenhydramine to the combination, using a 5-hour Phase Advance model of sleep challenge. This is a 3-arm cross-over study; each participant will receive 3 single-dose treatments on consecutive visits. The 3 arms are: investigational combination product, placebo, and a 2-drug comparator containing the zolpidem and lorazepam components but not diphenhydramine. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who are generally healthy and do not have chronic insomnia or sleep apnea.
A total of 39 subjects are being recruited. Subjects who qualify for participation will be asked to keep a sleep diary to document their sleep times leading up to and during the study, and will be asked to spend 7-8 hours in bed at a regular bedtime during the study. Qualifying participants also will not anticipate significant disruptions in their sleep schedules, for example by traveling across timezones or changing shifts at work, during the study. The study requires 3 one-night stays in a sleep center in New York City, for administration of the study treatments and EEG measurements. Qualifying subjects will anticipate being able to return to the sleep center, located in Manhattan, for a total of 4 visits, including initial screening and 3 treatment times.
During each sleep center visit, subjects will be given their study treatment and be put to bed 5 hours before their usual bedtime, and sleep time will be monitored for 8 hours. Each subject will receive all 3 treatments, although the sequence of the 3 treatments will be randomized. Both subjects and study personnel monitoring the subjects will be blinded to the identity of the treatment administered at each visit.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Single-Dose Study to Assess the Pharmacodynamic Effects of SM-1 Versus Comparator and Placebo in a 5 Hour Phase Advance Model of Insomnia in Adults Who Suffer From Short-Term Insomnia|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam
Active Comparator: Comparator
2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam
Placebo Comparator: Placebo
- Total Sleep Time [ Time Frame: 8 hours ]
- Latency to Persistent Sleep [ Time Frame: 8 hours ]Time it takes to fall asleep
- Awakenings [ Time Frame: 8 hours ]
- Latency to REM Sleep Onset [ Time Frame: 8 hours ]Time required to achieve REM sleep
- Adverse Events [ Time Frame: 8 hours ]Safety and tolerability assessed in terms of the incidence of AEs
- Safety and Tolerability in Terms of Residual Sleepiness [ Time Frame: 8 hours ]Karolinska Sleepiness Scale. This is a 9-point scale with values ranging from 1 (extremely alert) to 9 (extremely sleepy). Lower scores indicate less residual sleepiness.
- Safety and Tolerability in Terms of Residual Sleepiness [ Time Frame: 8 hours ]Digit Symbol Substitution Test. The test score is number of correct answers in 90 seconds. Higher scores indicate favorable response (i.e., less residual sleepiness). The duration of the challenge is the 90 second time limit; there is no theoretical maximum score to attain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671760
|Study Director:||Thomas Dahl, PhD||Sequential Medicine Ltd|
|Principal Investigator:||Maha Ahamad, MD||Clinilabs, Inc.|