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Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP)

Study acronym: STOP-I-SEP
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Jul 2026 to Jul 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jan 2028 to Jul 2027
    • Site details revised at 27 of 27 sites
    v9
  2. Study sites: 23 to 27
    • Eligibility criteria expanded, about 133 words
    v8
  3. Study sites: 21 to 23v7
  4. Primary completion date: Jul 2024 to Jul 2026
    • Study sites: 22 to 21
    • Study completion date: Jan 2026 to Jan 2028
    • Eligibility criteria expanded, about 20 words
    v6
  5. Site details revised at 3 of 22 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Site details revised at 20 of 22 sitesv4
  2. Eligibility criteria expanded, about 8 words
    • Site details revised at 2 of 22 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 22
    • Start date changed from estimate of Jan 2019 to Jan 24, 2019
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Further controlled and randomized prospective studies in Multiple sclerosis, analyzing the potential impact of treatment discontinuation on disability progression, focal disease activity and quality of life are needed. The optimum patient age and duration of inactive SPMS before treatment withdrawal and the monitoring procedures also need to be specified, the ultimate goal being to provide evidence-based recommendations for clinical practice. Following the previous retrospective experience, we decided to drive a multicenter prospective study in France based on the hypothesis that stopping disease modifying therapy will not induce an increased risk of disability progression and relapse in selected SPMS patients (older patients without lesion activity) but will improve the quality of life and may reduce treatment-related costs.
Trial Details
NCT Number NCT03653273
Lead Sponsor Rennes University Hospital
Conditions
(from sponsor)		 Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov