Safety and Efficacy Study of Daclizumab HYP to Treat Relapsing-Remitting Multiple Sclerosis


Tracking Information

Start Date  ICMJEFebruary 2008
Estimated Primary Completion DateSeptember 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)
  • the total lesion volume of new and newly enlarging T2 hyperintense lesions).
  • brain MRI measures (total number of gadolinium-enhancing lesions, number of new or newly-enlarging T2 hyperintense lesions, volume of new T1 hypointense lesions, and
Change HistoryComplete list of historical versions of study NCT00390221 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: July 28, 2009)
  • brain MRI measures (number of gd-enhancing lesions, number of new or newly-enlarging T2 hyperintense lesions) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • proportion of relapsing subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • improving quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJE 
 (submitted: October 18, 2006)
  • annualized relapse rate
  • time to first relapse
  • incidence of adverse events
  • incidence of development of antibodies to daclizumab

Descriptive Information

Brief Title  ICMJESafety and Efficacy Study of Daclizumab HYP to Treat Relapsing-Remitting Multiple Sclerosis
Official Title  ICMJEMulticenter, 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 PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEMultiple Sclerosis, Relapsing-Remitting
Intervention  ICMJE
  • Drug: daclizumab HYP
    SC injection, 150 mg and 300 mg every 4 weeks for 48 weeks
  • Other: placebo
    SC
Study Arms / Comparison Groups
  • 1: Placebo Comparator
    subcutaneous (SC)
    Intervention: Other: placebo
  • 2: Experimental
    daclizumab HYP SC
    Intervention: Drug: daclizumab HYP
  • 3: Experimental
    daclizumab HYP SC
    Intervention: Drug: daclizumab HYP

Recruitment Information

Estimated Enrollment  ICMJE600
Estimated Completion DateNovember 2011
Estimated Primary Completion DateSeptember 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • MS subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline EDSS between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:

    • Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial MRI demonstrating lesion(s) consistent with MS , OR
    • Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.
GenderBoth
Ages18 Years to 55 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Biogen Idecneurologyclinicaltrials@biogenidec.com
Location Countries  ICMJECzech Republic,   Germany,   Hungary,   India,   Poland,   Russian Federation,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00390221
Responsible PartyBiogen Idec MD, Biogen Idec, Inc.
Study ID Numbers  ICMJE205-MS-201
Study Sponsor  ICMJEBiogen Idec
Collaborators  ICMJEFacet Biotech
Investigators  ICMJE
Study Director:Biogen IdecBiogen Idec
Information Provided ByBiogen Idec