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NCT03621761 · ClinicalTrials.gov registry record · Phase 4
Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue
A Phase 4 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 343
- Enrollment target
NCT03621761: Completed Phase 4 study, sponsored by University of Michigan.
NCT03621761 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 343 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03621761, a Phase 4 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 343 participants
- Enrollment target
Study Summary
This clinical trial will compare the effectiveness of 3 treatments for fatigue in Multiple Sclerosis: 1) a commonly used behavioral treatment strategy (telephone-based cognitive behavioral therapy), 2) a commonly used medication (modafinil), and 3) a combination of both therapies. Each participant will receive one of these 3 treatments for a total of 12 weeks. Hypotheses are that, at 12 weeks, treatment with combination therapy will overall lead to greater reductions in fatigue impact, fatigue severity, and fatigability compared to monotherapy, and that comorbid depression, sleep disturbances, and baseline disability level will be important effect modifiers that influence treatment effect and adherence.
Primary Outcome
The Modified Fatigue Impact Scale is a 21-item self-report survey. Each item is rated 0-4, Total scores range from 0-84. . Higher scores indicate a greater impact of fatigue on a person's activities. The primary outcome measure will be the mean within-subject difference between baseline and 12-week Modified Fatigue Impact Scale values (delta-MFIS), compared between the 3 treatment groups.
Interventions
- DRUG Modafinil
- BEHAVIORAL Telephone-based Cognitive Behavioral Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 343 participants |
| Start Date | 2018-11-15 |
| Est. Completion | 2021-11-30 |
| Phase | Phase 4 |
What the finished NCT03621761 record still lists
NCT03621761 is an interventional study that assigns participants to a tested intervention. The registered 343 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 2 interventions - of which Modafinil is the first listed.
NCT03621761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03621761 about?
NCT03621761 is a clinical study titled "Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue". This clinical trial will compare the effectiveness of 3 treatments for fatigue in Multiple Sclerosis: 1) a commonly used behavioral treatment strategy (telephone-based cognitive behavioral therapy), 2) a commonly used medication (modafinil), and 3) a combination of both therapies. Each participant w...
What is the current status of trial NCT03621761?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 343 participants. The study started on 2018-11-15. Estimated completion is 2021-11-30.
What interventions are being tested in trial NCT03621761?
The interventions under investigation include: Modafinil (DRUG), Telephone-based Cognitive Behavioral Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03621761?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03621761's enrollment target sits among peer trials
343 246th of 2000 higher than 1,755 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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