Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

NCT06441617 | Recruiting DMC

• 2 other identifiers: ACP-CAFE-MS-001CDMRP- MS220136
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 6

Brief Summary

CAFE-MS will assess the effectiveness of two online programs for fatigue in multiple sclerosis (MS). Although they differ, both of these online programs contain information about MS and fatigue intended to help people with MS understand and manage their fatigue. 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.

Conditions

Multiple Sclerosis; Fatigue

Outcome Measures

Primary Outcomes (1)

• Chalder Fatigue Scale

  The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11).

  Day 180

Secondary Outcomes (4)

• PROMIS FatigueMS-8a

  Day 180

• PROMIS MS Health

  Day 180

• SymptoMScreen

  Day 180

• Frenchay Activities Index

  Day 180

Other Outcomes (1)

• Treatment Acceptability

  Day 180

Study Arms (3)

Fatigue Program A added to Treatment as Usual

EXPERIMENTAL

An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.

Device: Online Program for Fatigue

Fatigue Program B added to Treatment as Usual

ACTIVE COMPARATOR

Fatigue Program B will use a web-based interface with similar design and functionality as Fatigue Program A.

Device: Online Program for Fatigue

Treatment as Usual

NO INTERVENTION

Interventions

Online Program for Fatigue DEVICE

An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.

Fatigue Program A added to Treatment as Usual; Fatigue Program B added to Treatment as Usual

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent by person with MS
• 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)

You may not qualify if:

• Unwilling or unable to consent
• Refusal to saving, processing and forwarding of pseudonymized data
• Concurrent participation in another interventional trial

Sponsors & Collaborators

• Accelerated Cure Project for Multiple Sclerosis: lead
• University Medical Center Goettingen: collaborator
• US Department of Veterans Affairs: collaborator
• Congressionally Directed Medical Research Programs: collaborator
• United States Department of Defense: collaborator
• Charite University, Berlin, Germany: collaborator

Study Sites (6)

Washington VA Medical Center

Washington D.C., District of Columbia, 20422, United States

RECRUITING

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

iConquerMS

Waltham, Massachusetts, 02451, United States

RECRUITING

Portland VA Medical Center

Portland, Oregon, 97239, United States

RECRUITING

Nashville VA Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

Seattle VA Medical Center

Seattle, Washington, 98108, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Grace Okafor

CONTACT

781-487-0008; cafe-ms@iconquerms.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded with respect to Program A and Program B. However, the third arm of the trial, Treatment as Usual, will not be blinded. Since outcome assessments are collected online via surveys, the outcome assessor is a blinded entity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 4, 2024
• Study Start: December 5, 2024
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): September 14, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (6)