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A Study of Suvorexant in Patients With Multiple Sclerosis Fatigue and Insomnia

NCT03110315 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-02-03

Study results available
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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.

Conditions

Interventions

DRUG

Suvorexant

See detailed information in associated Arm Description.

DRUG

Placebo

Sugar pill manufactured to mimic suvorexant 10 mg tablet.

Sponsors & Collaborators

Principal Investigators

  • Theodore R Brown, MD, MPH · EvergreenHealth Multiple Sclerosis Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-28
Primary Completion
2022-03-21
Completion
2022-03-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03110315 on ClinicalTrials.gov