Safety and Efficacy Study of Daclizumab HYP to Treat Relapsing-Remitting Multiple Sclerosis
Tracking Information
Start Date ICMJE | February 2008 |
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Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: July 28, 2009) | Annualized Relapse Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: October 18, 2006) |
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Change History | Complete list of historical versions of study NCT00390221 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 28, 2009) |
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Original Secondary Outcome Measures ICMJE (submitted: October 18, 2006) |
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Descriptive Information
Brief Title ICMJE | Safety and Efficacy Study of Daclizumab HYP to Treat Relapsing-Remitting Multiple Sclerosis |
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Official Title ICMJE | Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis |
Brief Summary | The purpose of this study is to determine the effect of 2 different doses of daclizumab on reducing relapses in subjects with relapsing-remitting MS. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Multiple Sclerosis, Relapsing-Remitting |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 600 | ||||
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Estimated Completion Date | November 2011 | ||||
Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Czech Republic, Germany, Hungary, India, Poland, Russian Federation, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00390221 | ||||
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Responsible Party | Biogen Idec MD, Biogen Idec, Inc. | ||||
Study ID Numbers ICMJE | 205-MS-201 | ||||
Study Sponsor ICMJE | Biogen Idec | ||||
Collaborators ICMJE | Facet Biotech | ||||
Investigators ICMJE |
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Information Provided By | Biogen Idec |
Source: http://clinicaltrials.gov/