Multiple SclerosisCAFE-MSNCT06441617
Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
A study testing Online Program for Fatigue in people with Multiple Sclerosis and Fatigue, run by Accelerated Cure Project for Multiple Sclerosis at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Multiple Sclerosis, Fatigue
- What is being tested?
- Online Program for Fatigue
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 6 sitesUnited States
- Study dates
- 5 Dec 2024to 14 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- Unwilling or unable to consent
- Refusal to saving, processing and forwarding of pseudonymized data
- Concurrent participation in another interventional trial
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Baltimore VA Medical Center
Baltimore, Maryland, 21201
Nashville VA Medical Center
Nashville, Tennessee, 37212
Portland VA Medical Center
Portland, Oregon, 97239
Seattle VA Medical Center
Seattle, Washington, 98108
iConquerMS
Waltham, Massachusetts, 02451
Washington VA Medical Center
Washington D.C., District of Columbia, 20422
About this study
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
- Being tested
- Online Program for Fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Program for FatigueDevice
An MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Online Program for Fatigue |
| Treatment as Usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chalder Fatigue Scale
The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11).
Measured: Day 180
Secondary outcomes (4)
PROMIS FatigueMS-8a
The PROMIS FatigueMS-8a questionnaire has eight 5-point Likert scale items on different aspects of fatigue.
Measured: Day 180
PROMIS MS Health
PROMIS MS Health has 14 domains, each comprising four 5-point Likert scale items, covering mobility limitations, spasticity, reduced hand and arm function, fatigue, pain, numbness, cognition issues, sleep disturbances, bowel and bladder dysfunction, vision problems, dizziness and vertigo, sexual dysfunction, mood and emotional changes plus a single 5-point Likert scale item for overall health.
Measured: Day 180
SymptoMScreen
SymptoMScreen has twelve 7-point Likert scale items covering how each of the following MS symptoms affects everyday life activities: walking, hand function, spasticity, pain, sensory function, bladder control, fatigue, vision, dizziness, cognitive function, depression and anxiety.
Measured: Day 180
Frenchay Activities Index
The Frenchay Activities Index (FAI) is a measure of instrumental activities of daily living (IADL) for use with patients with neurological disorders. The FAI assesses a broad range of activities associated with everyday life that the patient has participated in within the recent past, broken into 3 domains: domestic chores, leisure/work, and outdoor activities.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start5 Dec 2024
- Primary completion15 Feb 2027 (estimated)
- Study completion14 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Accelerated Cure Project for Multiple Sclerosis
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, United States Department of Defense, Charite University, Berlin, Germany, University Medical Center Goettingen, US Department of Veterans Affairs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441617
- Sponsor's protocol ID
- ACP-CAFE-MS-001
- Other IDs
- CDMRP- MS220136
- Acronym
- CAFE-MS
- Status last verified
- Sep 2026
- First submitted
- 29 May 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06441617
- Acronym / sponsor ID
- CAFE-MS / ACP-CAFE-MS-001
- Conditions
- Multiple Sclerosis, Fatigue
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Accelerated Cure Project for Multiple SclerosisUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, United States Department of Defense, Charite University, Berlin, Germany, University Medical Center Goettingen, US Department of Veterans Affairs
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 14 Sep 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fatigue Program A added to Treatment as Usual | Experimental | Device: Online Program for FatigueAn 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 | Active comparator | Device: Online Program for FatigueFatigue Program B will use a web-based interface with similar design and functionality as Fatigue Program A. |
| Treatment as Usual | No intervention | – |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Unwilling or unable to consent
- Refusal to saving, processing and forwarding of pseudonymized data
- Concurrent participation in another interventional trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Program for FatigueAn MS-specific fatigue management program, delivered as a stand-alone, fully automated intervention via an internet-browser. | Device | Fatigue Program A added to Treatment as Usual, Fatigue Program B added to Treatment as Usual |
Primary outcome
Chalder Fatigue Scale
Time frame: Day 180
The scale contains 11 items covering physical fatigue (items 1-7) and mental fatigue (items 8-11).
4 secondary outcomes
PROMIS FatigueMS-8a
Time frame: Day 180
PROMIS MS Health
Time frame: Day 180
SymptoMScreen
Time frame: Day 180
Frenchay Activities Index
Time frame: Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Program for Fatigue in people with Multiple Sclerosis and Fatigue, run by Accelerated Cure Project for Multiple Sclerosis at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chalder Fatigue Scale (time frame: Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.