Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00330681 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

StatusCompleted
PhasePhase 3
SponsorShionogi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Tanabe Pharma Corporation to Shionogi
    • Primary and study completion dates: Sep 2008 to Sep 30, 2008
    • Start date: May 2006 to May 31, 2006
    v16
  2. Re-verified, no change to tracked fieldsv15
  3. Results first posted: May 17, 2017
    • Primary endpoint revised
    • Secondary endpoints: 2 to 8
    v14
  4. 2 versions Re-verified since Apr 18, 2012, no change to tracked fieldsv12-v13
  5. Enrollment target: estimated 200 to confirmed 206v11
Show 9 earlier versionsHide 9 earlier versions
  1. Trial status: Active, Not Recruiting to Completed
    • Study sites: 1 to 0
    • Eligibility criteria revised
    v10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  3. Primary and study completion dates: Sep 2008
    • Interventions: Edaravone (Radicut) (Drug) to MCI-186 (Drug), Placebo of MCI-186 (Drug)
    • Secondary endpoints: 1 to 2
    • Study arms: 0 to 2
    v8
  4. Re-verified, no change to tracked fieldsv7
  5. Site contact updatedv6
  6. Eligibility criteria revised
    • Secondary endpoint revised
    v5
  7. Eligibility criteria expanded, about 105 wordsv4
  8. Re-verified, no change to tracked fieldsv3
  9. Eligibility criteria shortened, about 17 wordsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
400 trials monitored
See 21 trials at risk
The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip once a day in patients with ALS 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.
Trial Details
NCT Number NCT00330681
Lead Sponsor Shionogi
Conditions
(from sponsor)		 Amyotrophic Lateral Sclerosis (ALS)
Related terms Amyotrophic Lateral Sclerosis
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov