An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis

NCT00398528 | Terminated

• 1 other identifier: MSAV1-2006
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 5

Brief Summary

Impaired short term memory, attention and concentration lapses, and slower processing of information occur in up to 40-65% of patients with Multiple Sclerosis (MS). The quality of life of individuals with MS is impacted to the degree with which they experience these symptoms. There are several medications approved by the United States Food and Drug Administration (FDA) to treat MS symptoms and to modify (slow) disease course. Traditional approaches to determining the effectiveness of medications used in treating MS rely on reports of the number of relapses an individual experiences, as well as standard clinical tests, such as the Kurtzke Expanded Disability Status Scale (EDSS). This research study will look at whether the functional magnetic resonance imaging (fMRI) scan can be used as a tool for measuring changes in the brain associated with treatment in MS patients. Unlike a typical MRI which provides structural information about the brain, the fMRI provides information about brain activity during performance of cognitive or motor tasks.

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Disease Modifying Therapy

Outcome Measures

Primary Outcomes (2)

• Examine the change in task-activated fMRI response as a function of disease modifying therapies assigned to MS.

• Secondary: fMRI as a surrogate marker for drug efficacy

Secondary Outcomes (1)

• fMRI as a surrogate marker for drug efficacy.

Interventions

Glatiramer acetate, (Copaxone®) DRUG

IFN-β-1a, (Avonex®) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent and HIPAA authorization.
• Age between 18 and 65 years
• Male and female subjects with clinically definite or laboratory-supported definite relapsing-remitting multiple sclerosis
• A minimum disease level according to the McDonald criteria for the definition of MS based on results of an MRI scan; acquired within 1 year (Subjects with other significant abnormal findings will be excluded)
• Receiving consistent therapy with Copaxone® or Avonex® for at least 1 year.
• Expanded Disability Status Score (EDSS) of 0 to ≤ 5.5, inclusive
• Exhibiting low or medium level of concern within 12 months prior to screening based on: relapses, or clinical progression, or MRI progression
• Clinical stability or improving neurological state during the eight weeks before Study Day 0
• Willingness \& ability to comply with the protocol for the duration of the study
• Confirmation that a subject capable of having children is not pregnant must be established by a negative urine pregnancy test within 30 days of Screening and a negative urine pregnancy test on Scan Days.

You may not qualify if:

• Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
• Progressive forms of MS (Primary progressive, Secondary progressive)
• Exhibiting a high level of concern within 12 months prior to screening based on: relapses, or clinical progression, or MRI progression
• Subjects who have been on DMTs other than Copaxone® or Avonex® for longer than 3 months
• Subjects who have been on Avonex® or Copaxone® for less than 3 months and have exhibited intolerability
• History of hypersensitivity to natural or recombinant interferon beta, human serum albumin, or any other component of the Avonex® formulation (for Avonex® Group A)
• History of hypersensitivity to glatiramer acetate or mannitol, or any other component of the Copaxone® formulation (for Copaxone® Group B)
• Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to screening
• Treatment with oral or systemic corticosteroids or ACTH within 4 weeks of screening or ongoing chronic treatment with systemic corticosteroids.
• Treatment with immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, methotrexate, azathiprine,linomide, mitoxantrone, Campath) within the 12 months prior to study day 0
• Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 0
• Prior use of cladribine or have received total lymphoid irradiation
• Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 6 months prior to screening
• Psychiatric disorder that is unstable or would preclude safe participation in the study
• Cognitive impairment which impairs ability to understand or comply with the protocol procedures

Sponsors & Collaborators

• Neurognostics: lead

Study Sites (5)

University of Southern California

Los Angeles, California, 90033, United States

Location

Minor & James Medical

Seattle, Washington, 98104, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Glatiramer Acetate; Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Proteins; Biological Factors

Study Officials

• Catherine L Elsinger, PhD

  Neurognostics, Inc.

  STUDY DIRECTOR

• Stephen M Rao, PhD

  Neurognostics, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: September 1, 2006
• Study Completion: November 1, 2007
• Last Updated: December 5, 2007

Record last verified: 2007-11

Locations

US (5)