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A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment target: 30 to 20v10 Show 5 more changesShow less
    • Primary completion date: Dec 2023 to Mar 2027
    • Study sites: 2 to 1
    • Study completion date: Dec 2023 to Oct 2027
    • Eligibility criteria expanded, about 22 words
    • Study title expanded, about 3 words
  2. Primary completion date: Jul 2022 to Dec 2023
    • Study completion date: Oct 2022 to Dec 2023
    • Site contacts updated at 1 of 2 sites
    v9
  3. Study sites: 1 to 2
    • Eligibility criteria expanded, about 8 words
    • Collaborators: 2 to 5
    v8
  4. Start date changed from estimate of Feb 2020 to Feb 24, 2020v7
  5. Start date: Jan 2020 to Feb 2020v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v5
  2. Start date: Dec 2019 to Jan 2020v4
  3. Eligibility criteria revisedv3
  4. Start date: Oct 2019 to Dec 2019v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 randomized multiple baseline feasibility trial where participants will start taking metformin at one of 3 randomly determined points (3-months, 6-months or 9 months) during the 12-month trial. All subjects will be on a daily dose of metformin for a minimum of 3 months and a maximum of 9 months.
Trial Details
NCT Number NCT04121468
Lead Sponsor The Hospital for Sick Children
Collaborators: Queen's University, Ontario Institute for Regenerative Medicine, Unity Health Toronto, Stem Cell Network, Multiple Sclerosis Society of Canada
Conditions
(from sponsor)		 Multiple Sclerosis (MS)
Related terms Multiple Sclerosis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov