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Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III

StatusCompleted
PhasePhase 3
SponsorShionogi
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Tanabe Pharma Corporation to Shionogi Primary and study completion dates: Jul 2008 to Jul 31, 2008 · Start date: Dec 2006 to Dec 31, 2006v11 Show all 3 changesShow less
    • Primary and study completion dates: Jul 2008 to Jul 31, 2008
    • Start date: Dec 2006 to Dec 31, 2006
  2. Re-verified, no change to tracked fieldsv10
  3. Results first posted: Dec 20, 2017 Primary endpoints: 1 to 7 · Secondary endpoints shortened, about 34 wordsv9 Show all 3 changesShow less
    • Primary endpoints: 1 to 7
    • Secondary endpoints shortened, about 34 words

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since Apr 18, 2012, no change to tracked fieldsv7-v8
  5. Enrollment target: estimated 20 to confirmed 25v6
Show 4 earlier versionsHide 4 earlier versions
  1. Trial status: Recruiting to Completed Study sites: 1 to 0 · Eligibility criteria expanded, about 1 wordv5 Show all 3 changesShow less
    • Study sites: 1 to 0
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoint revised Primary and study completion dates: Jul 2008 · Interventions: Edaravone (MCI-186, Radicut) (Drug) to MCI-186 (Drug), Placebo of MCI-186 (Drug) · Secondary endpoints: 1 to 2 · 1 morev4 Show all 5 changesShow less
    • Primary and study completion dates: Jul 2008
    • Interventions: Edaravone (MCI-186, Radicut) (Drug) to MCI-186 (Drug), Placebo of MCI-186 (Drug)
    • Secondary endpoints: 1 to 2
    • Study arms: 0 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv3
  4. Primary endpoint revised Interventions: Edaravone (Radicut) (Drug) to Edaravone (MCI-186, Radicut) (Drug)v2 Show all 2 changesShow less
    • Interventions: Edaravone (Radicut) (Drug) to Edaravone (MCI-186, Radicut) (Drug)

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Shionogi
45 trials monitored
See 2 trials at risk
ALS
387 trials monitored
See 18 trials at risk
The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via intravenous drip once a day in patients with ALS whose severity is classified as grade III, based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. And in addition, this study will be performed to examine the safety of MCI-186 to ALS patients who met severity classification III.
Trial Details
NCT Number NCT00415519
Lead Sponsor Shionogi
Conditions Amyotrophic Lateral Sclerosis (ALS)
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov