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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NBI-5788
Sponsored by
Neurocrine Biosciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring MS, Autoimmune disease, relapsing, progressive, Myelin, Myelin Basic Protein, MBP, acute fulminating, chronic progressive, Altered Peptide Ligand, APL, Neurocrine, NBI-5788, Relapse

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 8, 2004
    Last Updated
    March 20, 2008
    Sponsor
    Neurocrine Biosciences
    Collaborators
    Immune Tolerance Network (ITN)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00079495
    Brief Title
    Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)
    Official Title
    A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of NBI-5788 in Patients With Relapsing Multiple Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Neurocrine Biosciences
    Collaborators
    Immune Tolerance Network (ITN)

    4. Oversight

    5. Study Description

    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.
    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    150 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    NBI-5788

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chris O'Brien, MD
    Organizational Affiliation
    Neurocrine Biosciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.neurocrine.com
    Description
    Click here to find out more about the study sponsor: Neurocrine Biosciences, Inc.

    Learn more about this trial

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

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