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

StatusCompleted
PhasePhase 3
SponsorShionogi
Started

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Record History

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  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, 2006
    v11
  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 words
    v9
  4. 2 versions Re-verified since Apr 18, 2012, no change to tracked fieldsv7-v8
  5. Enrollment target: estimated 20 to confirmed 25v6
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  1. Trial status: Recruiting to Completed
    • Study sites: 1 to 0
    • Eligibility criteria expanded, about 1 word
    v5
  2. Primary endpoint revisedv4 Show 4 more 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
  3. Re-verified, no change to tracked fieldsv3
  4. Primary endpoint revised
    • Interventions: Edaravone (Radicut) (Drug) to Edaravone (MCI-186, Radicut) (Drug)
    v2
  1. Study First Submitted
  • 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
402 trials monitored
See 23 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
(from sponsor)		 Amyotrophic Lateral Sclerosis (ALS)
Related terms Amyotrophic Lateral Sclerosis
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov