CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 36 enrolled
Drug / intervention
Suvorexant +1 moredrug
Likely dose
Placebo 10 mgfrom 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/NCT03110315
NCT03110315Phase 4Completed
CompareCT.gov

A Double-blind, Crossover, Placebo-controlled Study to Compare the Effects of Nighttime Administration of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia

Theodore R. Brown, MD MPH·interventional·Posted Apr 12, 2017·Updated Feb 3, 2025

In Brief

A Phase 4 clinical trial evaluating Suvorexant and Placebo for Multiple Sclerosis and 2 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This study assesses the safety, tolerability, and efficacy of suvorexant in multiple sclerosis patients. Enrolled subjects will receive 2 weeks of treatment during treatment period 1 with either suvorexant or matching placebo (1:1). After treatment period 1, subjects will undergo a washout period of 1 week then 2 weeks of the alternate treatment (either suvorexant or placebo). The primary hypothesis is that suvorexant will provide greater improvement in sleep, as measured by symptom rating scales, compared to placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Fatigue, Insomnia
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 12, 2017
Enrollment StartMar 28, 2017
Primary CompletionMar 21, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 9.2 years ago

Interventions

Suvorexantdrug

See detailed information in associated Arm Description.

Placebodrug

Sugar pill manufactured to mimic suvorexant 10 mg tablet.