Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

Confirmatory Trial for Alleviating Fatigue in Multiple Sclerosis

Enrolling by invitationNot a drug-phase studyMS (type not specified)NCT06441617

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Online Program for Fatigue

What it measured

Main measures

  • Chalder Fatigue Scale

    Day 180

    Fatigue

Other measures (4)

  • PROMIS FatigueMS-8a

    Day 180

    Fatigue

  • PROMIS MS Health

    Day 180

    VisionThinking and memoryFatigueWalking and mobilityArm and hand functionSpasticityBladder, bowel and sexual functionPainMood and sleep

  • SymptoMScreen

    Day 180

    VisionThinking and memoryFatigueWalking and mobilityArm and hand functionSpasticityBladder, bowel and sexual functionPainMood and sleep

  • Frenchay Activities Index

    Day 180

Who could take part

MS (type not specified) · 22 and over

Show the full criteria

Inclusion criteria

* 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)

Exclusion criteria

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Dec 2024

    2. Main results due

      Feb 2027

    3. Finished

      Sept 2027

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