Status:
COMPLETED
Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)
Lead Sponsor:
Neurocrine Biosciences
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
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 inv...
Detailed Description
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 rel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00079495
Start Date
July 1 2003
End Date
April 1 2005
Last Update
March 21 2008
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