We are studying this investigational drug treatment, comparing it with placebo, to evaluate whether it is effective in reducing the number of MRI lesions with a minimum number of side effects. The investigational drug will be administered in the clinic weekly for 5 injections (induction phase) then monthly for 8 additional injections (maintenance phase).

Approximately 150 male and female patients (100 active and 50 placebo), aged 18 to 55 years, with relapsing MS and at least one but no more than 10 total Gd-enhancing lesions on cranial MRI scans during the run-in phase will be randomized into this study.

Condition	Treatment or Intervention	Phase
Multiple Sclerosis	Drug: NBI-5788	Phase II

This is a multicenter, randomized, double-blind, placebo-controlled trial in which qualifying patients will be randomized 2:1 to receive active drug or placebo. Eligible patients must have MS with relapse, have had one or more relapses during the prior 2 years, 1-10 gadolinium (Gd)-enhancing lesions on the Run-in MRI, and an EDSS of 6.5 or less. There are exclusions for certain prior MS treatments and medical / psychiatric conditions. Following a 4-week run-in phase in which patients will have a baseline MRI, patients will enter a 4 week induction phase, during which they will be receive injections weekly (5 doses), then a 32-week maintenance phase during which injections are monthly (8 doses). A final follow-up visit will be conducted 4 weeks after the last injection. The primary efficacy parameter is a summary change score of the mean number of total Gd-enhancing lesions at weeks 36 and 40 minus the mean number for the two baseline scans. Safety monitoring will include AE/SAE reporting, physical exams, vital signs, ECG. CXR, laboratory tests, neurologic evaluations, and systemic hypersensitivity and injection site assessments. All study medications will be administered by study personnel and patients will remain under observation for a minimum of 2 hours post-injection. An independent Data Safety and Monitoring Board will oversee the safety of the trial.

Ages Eligible for Study:  18 Years   -   55 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or female, 18 to 55 years of age
• Diagnosed with relapsing multiple sclerosis, with at least one relapse in the last two years
• Females must not plan on becoming pregnant
• Females must either be post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control and willing to continue birth control until 30 days after the last dose of study drug
• Males must not intend to impregnate a partner during the study or for 30 days after the study and must also practice acceptable birth control with their partners

Exclusion Criteria:

• Significant long-lasting disease of the immune system other than multiple sclerosis
• Past or current medical disease (heart, liver, kidney, etc.) including severe asthma, cancer or advancing brain or spinal cord disorder
• Known or suspected long-lasting infectious disease including HIV, hepatitis B, or hepatitis C
• Treatment with certain steroid or hormone medications within 30 days before the pre-study MRI scan
• Treatment with other medications that suppress the immune system within 6 months before the pre-study MRI scan
• Certain treatments and medications are not allowed
• Laboratory and other tests will be performed to determine further eligibility
• History of drug or alcohol abuse in the last year
• History of medical or psychiatric condition that could pose a risk for participation in the study
• Females who are pregnant or breast feeding
• Participation in any other trial of an investigational agent within 90 days before the start of the study
• History of not following instructions with past therapy.

Arizona
      Barrow Neurological Institute, Phoenix,  Arizona,  85013,  United States; Recruiting
California
      UC Davis, Sacramento,  California,  95817,  United States; Recruiting
      University of California at Irvine, Irvine,  California,  92697,  United States; Recruiting
Connecticut
      Yale Center for MS Treatment and Research, New Haven,  Connecticut,  06510,  United States; Recruiting
Georgia
      Sheperd Center, Atlanta,  Georgia,  30309,  United States; Recruiting
Indiana
      Indiana University, Indianapolis,  Indiana,  46202,  United States; Recruiting
Kansas
      University of Kansas Medical Center, Kansas City,  Kansas,  66160,  United States; Recruiting
Michigan
      Henry Ford Hospital and Health System, Detroit,  Michigan,  48202,  United States; Recruiting
Missouri
      Washington University MS Center, St. Louis,  Missouri,  63110,  United States; Recruiting
New Mexico
      University of New Mexico, Albuquerque,  New Mexico,  87131,  United States; Recruiting
New York
      Stony Brook University Hospital, Stony Brook,  New York,  11794,  United States; Recruiting
North Carolina
      Wake Forest University, Winston Salem,  North Carolina,  27157,  United States; Recruiting
Ohio
      Ohio State University, Columbus,  Ohio,  43210,  United States; Recruiting
Pennsylvania
      Multiple Sclerosis Institute, Philadelphia,  Pennsylvania,  19146,  United States; Recruiting
      University of Pennsylvania MS Center, Philadelphia,  Pennsylvania,  19104,  United States; Recruiting
Texas
      Integra Clinical Research, San Antonio,  Texas,  78229,  United States; Recruiting
      North Texas Neurology, Wichita Falls,  Texas,  76301,  United States; Recruiting
      Texas Neurology, Dallas,  Texas,  75214,  United States; Recruiting
Washington
      University of Washington, Seattle,  Washington,  98195,  United States; Recruiting
Canada, Alberta
      Foothills Medical Centre, Calgary,  Alberta,  T2N 2T9,  Canada; Recruiting
Canada, British Columbia
      University of British Columbia, Vancouver,  British Columbia,  V6T 2B5,  Canada; Recruiting
Canada, Nova Scotia
      Dalhousie Multiple Sclerosis Research Unit, Halifax,  Nova Scotia,  B3H 1V7,  Canada; Recruiting
Canada, Ontario
      The Ottawa Hospital - General Campus, Ottawa,  Ontario,  K1H 8L6,  Canada; Recruiting
Canada, Quebec
      Montreal Neurological Institute, Montreal,  Quebec,  H3A 2B4,  Canada; Recruiting

Study chairs or principal investigators

Michael Skinner, MD, PhD,  Study Director,  Neurocrine Biosciences   

Study ID Numbers:  NBI-5788-0201; MS APL; Neurocrine
Record last reviewed:  March 2004
Record first received:  March 8, 2004
ClinicalTrials.gov Identifier:  NCT00079495
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10