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Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)

NCT00079495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2008-03-21

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

NBI-5788

Sponsors & Collaborators

  • Immune Tolerance Network (ITN)

    collaborator NETWORK

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Chris O'Brien, MD · Neurocrine Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Completion
2005-04-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00079495 on ClinicalTrials.gov