Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06170970
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Solriamfetol — DRUG
    solriamfetol 75 mg daily for 3 days and will increase the dose to 150 mg daily starting on day 4 of the treatment period (total of four weeks)
  • Placebo — DRUG
    Four weeks of oral placebo

Study Details

Fatigue is a prevalent and disabling symptom in Multiple Sclerosis (MS), affecting up to 90% of patients. Current treatments, including off-label prescriptions of wake-promoting agents, have shown limited effectiveness. Previous research indicates that these agents may be beneficial specifically for MS patients with concomitant excessive daytime sleepiness. This study uses a randomized, double-blind, placebo-controlled crossover design. Participants will undergo a 10-day lead-in with he medication/placebo, followed by two four-week treatment periods separated by a one-week washout. Outcomes will be measured primarily using the Modified Fatigue Impact Scale (MFIS), with additional exploratory measures collected via a smartphone app that assesses fatigue through keystroke dynamics. This novel approach to fatigue measurement aims to capture real-time variations and provide more granular data than traditional self-report questionnaires.

Key Dates

Start date
Jun 1, 2024
Status verified
Jun 2026
Primary completion
Dec 1, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: solriamfetol then placebo first
    Four weeks of treatment with solriamfetol followed by one week of washout and four weeks of treatment with placebo
  • Experimental: placebo then solriamfetol first
    Four weeks of treatment with placebo followed by one week of washout and four weeks of treatment with solriamfetol

Primary Outcome Measure

Modified Fatigue Impact Scale (MFIS) Score [ Time Frame: Up to 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21287
Mahsa Ghajarzadeh, MD, PhD
[email protected]
410-614-1522
Lauren Vega, BSN
[email protected]
410-614-1522

Find similar trials in Baltimore, MD

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Johns Hopkins University· Baltimore, MD

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