Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
NCT ID: NCT06441617
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2024-12-05
2027-09-14
Brief Summary
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This large-scale, decentralized clinical trial is projected to enroll 2,000 people with MS. The collaboration between iConquerMS and 5 Veterans Affairs (VA) sites in the MS Centers of Excellence is designed to ensure sufficient representation of people with MS from populations traditionally under-represented in MS clinical trials.
The study is a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for managing fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Fatigue Program A added to Treatment as Usual
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.
Online Program for Fatigue
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.
Fatigue Program B added to Treatment as Usual
Fatigue Program B will use a web-based interface with similar design and functionality as Fatigue Program A.
Online Program for Fatigue
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.
Treatment as Usual
No interventions assigned to this group
Interventions
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Online Program for Fatigue
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.
Eligibility Criteria
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Inclusion Criteria
* Living in the US
* Age ≥ 22
* Confirmed diagnosis of MS by a physician, who is a neurologist or has access to a neurologist's statement of diagnosis
* Fatigue Severity Scale score at or above eligibility threshold
* Fluent in English
* Willingness to engage in self-administration of an online intervention for 24 weeks and complete follow-up assessments
* Access to the internet and e-mail with a compatible device (smartphone, computer, or tablet)
* No MS relapse / no steroid treatment in the 4 weeks prior to answering the screening questionnaire (self-reported)
* No disease-modifying therapeutic (DMT) started in the 4 weeks prior to answering the screening questionnaire (self-reported)
Exclusion Criteria
* Refusal to saving, processing and forwarding of pseudonymized data
* Concurrent participation in another interventional trial
22 Years
ALL
No
Sponsors
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Congressionally Directed Medical Research Programs
FED
United States Department of Defense
FED
Charite University, Berlin, Germany
OTHER
University Medical Center Goettingen
OTHER
US Department of Veterans Affairs
FED
Accelerated Cure Project for Multiple Sclerosis
OTHER
Responsible Party
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Locations
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Washington VA Medical Center
Washington D.C., District of Columbia, United States
Baltimore VA Medical Center
Baltimore, Maryland, United States
iConquerMS
Waltham, Massachusetts, United States
Portland VA Medical Center
Portland, Oregon, United States
Nashville VA Medical Center
Nashville, Tennessee, United States
Seattle VA Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Mitchell Wallin, MD, MPH
Role: backup
Carin Waslo, MPH
Role: backup
Other Identifiers
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CDMRP- MS220136
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ACP-CAFE-MS-001
Identifier Type: -
Identifier Source: org_study_id
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