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| Sponsor: | PDL BioPharma, Inc. |
|---|---|
| Information provided by: | Facet Biotech |
| ClinicalTrials.gov Identifier: | NCT00109161 |
Purpose
This research study is being conducted in the U.S. and Europe to evaluate the safety and efficacy of daclizumab for the treatment of multiple sclerosis (MS).
| Condition | Intervention | Phase |
|---|---|---|
|
Multiple Sclerosis |
Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis |
| Estimated Enrollment: | 270 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | October 2006 |
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 36 Study Locations| Principal Investigator: | Richard Dickson, M.D. | Wenatchee Valley Medical Center |
| Principal Investigator: | Steven Pugh, M.D. | Rockwood Clinic, PS |
| Principal Investigator: | Daniel Wynn, M.D. | Consultants in Neurology |
| Principal Investigator: | Theodore J. Phillips, M.D. | The MS Center at Texas Neurology |
| Principal Investigator: | Joanna Cooper | Sutter East Bay Medical Foundation |
| Principal Investigator: | James R. Storey | Upstate Clinical Research |
| Principal Investigator: | Malcolm Gottesman, M.D. | Winthrop University Hospital |
| Principal Investigator: | Herman Sullivan, M.D. | Michigan Medical P.C. Neurology |
| Principal Investigator: | Timothy Vollmer, M.D. | St. Joseph's Hospital and Medical Center, Phoenix |
| Principal Investigator: | Jeffery Dunn, M.D. | MS Hub Medical Group |
| Principal Investigator: | S. Mitchell Freedman, M.D. | Raleigh Neurology Associates |
| Principal Investigator: | Joseph Herbert, M.D. | Hospital for Joint Diseases, MS Care Center |
| Principal Investigator: | Omar Khan, M.D. | Wayne State University MS Center |
| Principal Investigator: | Marcelo Kremenchutzky, M.D. | London Health Sciences Centre |
| Principal Investigator: | Sharon Lynch, M.D. | CLMC Neurology |
| Principal Investigator: | Alireza Minagar, M.D. | Louisiana State University Health Sciences Center |
| Principal Investigator: | Jeffrey English, M.D. | The Multiple Sclerosis Center of Atlanta |
| Principal Investigator: | Andrew Goodman, M.D. | University of Rochester |
| Principal Investigator: | Michael Kaufman, M.D. | MS Center/CMC |
| Principal Investigator: | Florian P. Thomas, M.D. | St. Louis University Hospital |
| Principal Investigator: | Clyde Markowitz, M.D. | University of Pennsylvania |
| Principal Investigator: | Jayne Martin, M.D. | Michigan State University |
| Principal Investigator: | Maria Melanson, M.D. | Health Sciences Center |
| Principal Investigator: | MaryAnn Picone, M.D. | Gimble MS Center |
| Principal Investigator: | Christopher Bever, M.D | Maryland Center for MS |
| Principal Investigator: | Gregg G. Blevins, M.D. | University of Alberta |
| Principal Investigator: | Kasper Lloyd, M.D. | MS Center at Dartmouth |
| Principal Investigator: | Yves Lapierrre, M.D. | Montreal Neurological Institute |
| Principal Investigator: | John W. Rose, M.D. | University of Utah CAMT |
| Principal Investigator: | Michael Yeung, M.D. | Foothills Medical Centre |
| Principal Investigator: | Neil Lava, M.D. | Albany Medical College |
| Principal Investigator: | Jonathan L. Carter, M.D. | Mayo Clinic |
| Principal Investigator: | Francois Jacques, M.D. | Clinique SEP/NM |
| Principal Investigator: | William Honeycutt, M.D. | Neurology Associates, P.A. |
| Principal Investigator: | Istvan Pirko, M.D. | University of Cincinnati |
| Principal Investigator: | Ed Fox, M.D. | Central Texas Neurology |
More Information
| ClinicalTrials.gov Identifier: | NCT00109161 History of Changes |
| Other Study ID Numbers: | DAC-1012 |
| Study First Received: | April 22, 2005 |
| Last Updated: | August 2, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Multiple Sclerosis, MS, CNS, Daclizumab |
|
Multiple Sclerosis Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Pathologic Processes Antibodies, Monoclonal Daclizumab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents |