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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00109161 |
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Date of registration:
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22/04/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis
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Scientific title:
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A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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270 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00109161 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Ed Fox, M.D. |
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Address:
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Affiliation:
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Central Texas Neurology |
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Name:
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Sharon Lynch, M.D. |
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Address:
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Affiliation:
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CLMC Neurology |
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Name:
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Michael Kaufman, M.D. |
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Address:
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Email:
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Affiliation:
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MS Center/CMC |
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Name:
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James R. Storey |
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Address:
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Email:
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Affiliation:
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Upstate Clinical Research |
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Name:
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Theodore J. Phillips, M.D. |
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Address:
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Email:
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Affiliation:
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The MS Center at Texas Neurology |
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Name:
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Neil Lava, M.D. |
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Address:
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Affiliation:
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Albany Medical College |
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Name:
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Christopher Bever, M.D |
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Address:
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Affiliation:
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Maryland Center for MS |
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Name:
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Yves Lapierrre, M.D. |
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Address:
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Affiliation:
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Montreal Neurological Institute |
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Name:
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Florian P. Thomas, M.D. |
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Address:
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Affiliation:
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St. Louis University Hospital |
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Name:
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Jeffrey English, M.D. |
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Address:
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Email:
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Affiliation:
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The Multiple Sclerosis Center of Atlanta |
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Name:
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Clyde Markowitz, M.D. |
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Address:
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Affiliation:
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University of Pennsylvania |
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Name:
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MaryAnn Picone, M.D. |
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Address:
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Email:
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Affiliation:
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Gimble MS Center |
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Name:
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Maria Melanson, M.D. |
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Address:
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Affiliation:
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Health Sciences Center |
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Name:
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Marcelo Kremenchutzky, M.D. |
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Address:
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Affiliation:
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London Health Sciences Centre |
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Name:
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Jayne Martin, M.D. |
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Address:
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Affiliation:
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Michigan State University |
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Name:
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Kasper Lloyd, M.D. |
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Address:
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Email:
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Affiliation:
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MS Center at Dartmouth |
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Name:
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William Honeycutt, M.D. |
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Address:
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Email:
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Affiliation:
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Neurology Associates, P.A. |
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Name:
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Steven Pugh, M.D. |
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Address:
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Affiliation:
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Rockwood Clinic, PS |
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Name:
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Andrew Goodman, M.D. |
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Address:
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Affiliation:
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University of Rochester |
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Name:
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Francois Jacques, M.D. |
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Address:
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Affiliation:
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Clinique SEP/NM |
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Name:
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Daniel Wynn, M.D. |
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Address:
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Affiliation:
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Consultants in Neurology |
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Name:
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Alireza Minagar, M.D. |
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Address:
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Email:
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Affiliation:
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Louisiana State University Health Sciences Center |
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Name:
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S. Mitchell Freedman, M.D. |
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Address:
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Affiliation:
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Raleigh Neurology Associates |
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Name:
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Malcolm Gottesman, M.D. |
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Address:
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Email:
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Affiliation:
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Winthrop University Hospital |
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Name:
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Herman Sullivan, M.D. |
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Address:
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Affiliation:
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Michigan Medical P.C. Neurology |
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Name:
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Jeffery Dunn, M.D. |
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Address:
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Email:
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Affiliation:
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MS Hub Medical Group |
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Name:
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Joanna Cooper |
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Address:
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Email:
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Affiliation:
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Sutter East Bay Medical Foundation |
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Name:
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Omar Khan, M.D. |
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Address:
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Email:
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Affiliation:
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Wayne State University MS Center |
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Name:
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Richard Dickson, M.D. |
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Address:
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Affiliation:
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Wenatchee Valley Medical Center |
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Name:
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Michael Yeung, M.D. |
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Address:
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Email:
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Affiliation:
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Foothills Medical Centre |
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Name:
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Jonathan L. Carter, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Name:
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John W. Rose, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Utah CAMT |
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Name:
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Joseph Herbert, M.D. |
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Address:
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Email:
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Affiliation:
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Hospital for Joint Diseases, MS Care Center |
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Name:
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Timothy Vollmer, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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St. Joseph's Hospital and Medical Center, Phoenix |
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Name:
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Gregg G. Blevins, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Name:
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Istvan Pirko, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cincinnati |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female age 18 to 55 years, inclusive.
- Diagnosis of MS by McDonald criteria.
- EDSS <7.0.
- On stable IFN-beta regimen for at least 6 months.
- The occurrence of either of the following within 9 months prior to screening: =1
MS relapse OR A qualifying MRI, defined as an MRI that showed at least one confirmed
Gd-CEL of the brain or spinal cord, was performed independently of the study while
the patient was on a stable IFN-beta regimen, and is deemed acceptable by the central
reader.
- For females, women of non-childbearing potential or women of childbearing potential
who provide a negative serum pregnancy test at screen and within 24 hours of first
dose of study drug, and who agree to use effective contraception during the Treatment
and Follow-up periods of the study.
- Willing and able to comply with the protocol, provision of informed consent in
accordance with institutional and regulatory guidelines, and, for US sites only,
authorization to use protected health information.
Exclusion Criteria:
- Pregnant or breast-feeding woman.
- Non-ambulatory patient.
- Clinically significant abnormality on screening ECG.
- Malignancy within the past 5 years, except for adequately treated non-melanoma skin
carcinoma or in situ carcinoma of the cervix.
- History of HIV infection, positive serology for HBV (hepatitis B virus) or HCV
(hepatitis C virus).
- Varicella (VZV) or herpes zoster virus infection, or any severe viral infection,
within 6 weeks before screening or exposure to VZV within 21 days of screening.
- Abnormal hematology, as defined by the following laboratory values: *Hemoglobin =8.5
g/dL, *Lymphocytes =1.0 x 10^9/L, *Platelets =100 x 10^9/L, *Neutrophils =1.5 x
10^9/L.
- Significant organ dysfunction, including but not limited to cardiac, renal, liver,
non-MS related CNS, pulmonary, vascular, gastrointestinal, endocrine, or metabolic
dysfunction, or other disease or condition, which in the opinion of the PI (principal
investigator) would make the patient an unsuitable candidate for the study.
Guidelines for levels of unacceptable dysfunction include: *creatinine =1.6 mg/dL;
*AST and ALT =2.5 times upper limit of normal (ULN); *alkaline phosphatase =2.5 times
ULN; *history of myocardial infarction, congestive heart failure, or arrhythmias
within 6 months prior to randomization.
- Use of any of the following: *Any of the following types of live virus vaccine from 4
weeks before randomization: measles/mumps/rubella vaccine, varicella zoster virus
vaccine, oral polio vaccine, and nasal influenza vaccine. Use of these vaccines,
however, by household contacts does not affect the eligibility of patients to enroll
or continue in the study; *Systemic corticosteroids, adrenocorticotropic hormone, or
plasma exchange within 4 weeks before the baseline MRI scan (no more than 72 hours
before Day 0); *Azathioprine, mycophenolate mofetil, methotrexate, glatiramer
acetate, or intravenous immune globulin within 6 months before randomization; *An
immunomodulatory agent within 6 months before randomization, except for
interferon-beta products required per protocol; *An investigational agent within 6
months before randomization unless this agent is non-immunomodulatory and the medical
monitor or steering committee rules that its use is acceptable on the theoretical
basis of a lapse of at least 5 serum half-lives since administration of the last
possible dose; *A monoclonal antibody (eg, Rituxan®/ Rituximab) within 6 months
before randomization; *Daclizumab at any time prior to randomization; *Cladribine,
mitoxantrone, cyclophosphamide, CamPath® (alemtuzumab), natalizumab
(TYSABRI®/Antegren) or other drugs targeting alpha 4 integrin, total lymphoid
irradiation, or bone marrow transplant at any time
- Patients for whom MRI is contraindicated, ie, have pacemakers or other
contraindicated implanted metal devices, are allergic to gadolinium, or have
claustrophobia that cannot be medically managed.
- Primary progressive MS.
- Clinically unstable for 30 days before randomization (Patients who experienced a
relapse, with or without steroid treatment, during the screening period may be
re-screened after 30 days.)
- Elective surgery performed from 2 weeks prior to randomization or scheduled through
Week 44
- Infection (viral, fungal, bacterial) requiring hospitalization or IV antibiotics
within 8 weeks before randomization.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody)
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Primary Outcome(s)
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Number of new or enlarged gadolinium contrast enhancing lesions (Gd-CELs) on monthly brain MRIs collected between Weeks 8 to 24 in daclizumab- vs. placebo-treated patients
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Secondary Outcome(s)
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Clinical improvement
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Pharmacokinetics
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Immunogenicity
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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