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

NCT00079495 | Completed Phase 2

• 3 other identifiers: NBI-5788-0201MS APLNeurocrine
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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 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

Multiple Sclerosis

Keywords

MS; Autoimmune disease; relapsing; progressive; Myelin; Myelin Basic Protein; MBP; acute fulminating; chronic progressive; Altered Peptide Ligand; APL; Neurocrine; NBI-5788; Relapse

Interventions

NBI-5788 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurocrine Biosciences: lead
• Immune Tolerance Network (ITN): collaborator

MeSH Terms

Conditions

Multiple Sclerosis; Autoimmune Diseases; Recurrence

Interventions

NBI 5788

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris O'Brien, MD

  Neurocrine Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 10, 2004
• Study Start: July 1, 2003
• Study Completion: April 1, 2005
• Last Updated: March 21, 2008

Record last verified: 2007-09