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NCT06170970 · ClinicalTrials.gov registry record · Phase 2
Solriamfetol for the Treatment of Multiple Sclerosis Fatigue
A Phase 2 study of Multiple Sclerosis and Multiple Sclerosis Fatigue, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT06170970 is a Phase 2 study of Multiple Sclerosis and Multiple Sclerosis Fatigue that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 46 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06170970, a Phase 2 study of Multiple Sclerosis and Multiple Sclerosis Fatigue, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Solriamfetol
Study Locations (1)
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2027-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06170970
The ClinicalTrials.gov registry entry for NCT06170970 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (92% lower). The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06170970 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06170970 about?
NCT06170970 is a clinical study titled "Solriamfetol for the Treatment of Multiple Sclerosis Fatigue". 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...
What is the current status of trial NCT06170970?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2024-06-01. Estimated completion is 2027-03-01.
What conditions does trial NCT06170970 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Multiple Sclerosis Fatigue.
What interventions are being tested in trial NCT06170970?
The interventions under investigation include: Placebo (DRUG), Solriamfetol (DRUG).
Who is sponsoring clinical trial NCT06170970?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06170970 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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