A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Part of paid clinical trials in Rochester Hills, Michigan.

Sponsor
Rochester Center for Behavioral Medicine
Study ID
NCT04622293
Phase
PHASE4
Status
Completed

Conditions

  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Solriamfetol Oral Tablet [Sunosi] — DRUG
    Solriamfetol will be given to those participants placed in the experimental group, and given at three possible dosages ( 37.5 mg, 75 mg, and 150 mg). Solriamfetol is already FDA approved for treatment of excessive daytime sleepiness, and has been found safe to use. In this study, we are determining if solriamfetol can also be used to treat chronic fatigue syndrome.
  • Placebo — DRUG
    A placebo encapsulated to look the same as the experimental drug will be given to the control group.

Study Details

This study is an 8-week single center, randomized, double-blind, placebo-controlled, flexible titration trial evaluating the efficacy of solriamfetol in the treatment of fatigue symptoms in adult patients with chronic fatigue syndrome. Subjects will be randomized to a solriamfetol group or placebo group. The investigators will utilize an intent to treat model and impute data. The overall goal of this study is to determine the efficacy and effectiveness of solriamfetol for treating chronic fatigue syndrome.

Key Dates

Start date
Apr 27, 2021
Status verified
Apr 2025
Primary completion
Sep 1, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
44 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Solriamfetol
    Those who are receiving solriamfetol will receive 75 mg or 150 mg. Patients will begin at a 75 mg dose and then after three days titrate up or down as needed, determined by consultation visits with primary investigator. Solriamfetol will be taken orally.
  • Placebo Comparator: Placebo
    Those who are not receiving solriamfetol will receive the placebo drug, which will be encapsulated in matching capsules to reduce any bias or speculation with participants.

Primary Outcome Measure

Fatigue Symptom Inventory (FSI) [ Time Frame: Up to 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rochester Center for Behavioral MedicineRochester HillsMichigan48307-

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Rochester Center for Behavioral Medicine· Rochester Hills, MI

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