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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 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 343 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03621761
The ClinicalTrials.gov registry entry for NCT03621761 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 343 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Modafinil is the first listed.
NCT03621761 reports 0 study locations.
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.
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