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Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Eligibility criteria shortened, about 14 words
    • Secondary endpoints: 11 to 10
    • Study description expanded, about 16 words
    v8
  2. Re-verified, no change to tracked fieldsv7
  3. Study completion date: Jan 1, 2027 to Sep 1, 2027v6
  4. Primary completion date changed from estimate of Oct 1, 2022 to Aug 1, 2022v5
  5. Trial status: Recruiting to Active, Not Recruitingv4 Show 5 more changesShow less
    • Enrollment target: estimated 60 to confirmed 44
    • Primary completion date: Jan 1, 2023 to Oct 1, 2022
    • Secondary endpoints: 2 to 11
    • Study description expanded, about 38 words
    • Site details revised
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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Primary completion date: Dec 2021 to Jan 1, 2023
    • Study completion date: Jul 2025 to Jan 1, 2027
    • Start date changed from estimate of Jul 2020 to May 1, 2020
    • Secondary endpoints: 3 to 2
    • Site details revised
  2. Start date: Oct 2019 to Jul 2020v2 Show 4 more changesShow less
    • Study completion date: Jul 2022 to Jul 2025
    • Secondary endpoints: 7 to 3
    • Study description shortened, about 41 words
    • Study title shortened, about 2 words
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A key question in efforts to reduce symptoms and improve quality of life for multiple sclerosis (MS) patients is whether a therapeutic lifestyle (diet, stress reduction and exercise) is inferior to disease-modifying drug treatments in terms of reducing multiple sclerosis related symptoms, improving function and quality of life. This study will prospectively assess the changes in quality of life and clinical outcomes in two cohorts of patients who are recently diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) to begin answering that question. The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor to the development of MS. Due to the COVID 19 Pandemic, the study was redesigned from an in-person study to a virtual visit only study prior to enrolling study subjects.
Trial Details
NCT Number NCT04009005
Lead Sponsor Terry L. Wahls
Conditions
(from sponsor)		 Clinically Isolated Syndrome, Relapsing Remitting Multiple Sclerosis
Related terms Multiple Sclerosis, Relapsing-Remitting
Enrollment 44 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov