Expanded Controlled Study of Safety and Efficacy of MCI-186 in Patients With Amyotrophic Lateral Sclerosis (ALS)

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: May 2009 to May 31, 2009
    • Start date: Jan 2007 to Jan 31, 2007
    v12
  2. 2 versions Re-verified since Jul 24, 2018, no change to tracked fieldsv10-v11
  3. Secondary endpoints revised (6)v9
  4. Results first posted: Jun 4, 2018
    • Primary endpoint revised
    • Secondary endpoints: 2 to 6
    • Publications: 1 to 2
    v8
  5. Enrollment target: estimated 140 to confirmed 181v7
Show 5 earlier versionsHide 5 earlier versions
  1. Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Jul 2009 to May 2009
    v6
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  3. Primary endpoint revisedv4 Show 5 more changesShow less
    • Primary and study completion dates: Jul 2009
    • Start date: Jan 2007
    • Interventions: MCI-186 (Edaravone, Radicut) (Drug) to MCI-186 (Drug), Placebo of MCI-186 (Drug)
    • Secondary endpoints revised (2)
    • Study arms: 0 to 2
  4. Re-verified, no change to tracked fieldsv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    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
This is a long-term, double-blind, placebo-controlled study of MCI-186 to treat ALS. This study is the long-term extension of Study NCT00330681; Study NCT00330681 is a Phase 3, randomized, double-blind, placebo control, parallel assignment, 24-week study in the treatment of ALS. The objectives of this study are to assess the efficacy and safety of long-term intermittent therapy with 60 mg MCI-186 to ALS patients.
Trial Details
NCT Number NCT00424463
Lead Sponsor Shionogi
Conditions
(from sponsor)		 Amyotrophic Lateral Sclerosis (ALS)
Related terms Amyotrophic Lateral Sclerosis
Enrollment 181 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov