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

• Status: Terminated
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurognostics
• Treatments: (T,G)-A-L; Glatiramer Acetate; Interferon beta-1a

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

• Significant leucopenia (white blood cell count <0.5 times the lower limit of normal)as assessed during the course of routine standard of care

• Elevated liver function tests (ALT, AST, alkaline phosphatase or total bilirubin >2 times the upper limit of normal) as assessed during the course of routine standard of care

• Specific systemic diseases, (including insulin-dependent diabetes, Lyme disease,clinically significant cardiac disease, HIV, HTLV-1, and Hepatitis B or C), or other uncontrolled major medical conditions (depression, seizure disorder) that would interfere with the participant's safety, compliance or evaluation

• Unable and/or unlikely to follow the protocol for any reason

• Alcohol and/or any other drug abuse

• Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol

• Abnormal baseline clinical findings considered by the investigator to be indicative of conditions that might affect study results

• Impaired renal function, as shown by but not limited to serum creatinine >2.5 mg/dL

• Subjects who cannot take the FDA approved medication for any reason will be excluded

• Corticosteroids allowed at doses between 500 mg and 1000 mg IV (over 3-5 days for relapses) IV for a maximum of three days

In addition, specific exclusion criteria are required for MRI scanning:

• Ferrous objects within the body

• Pregnancy

• Weight inappropriate for height

• Low visual acuity that cannot be corrected with glasses

• History of claustrophobia

• Participants whose high-resolution anatomic MR scans reveal the presence of a structural abnormality (other than MS).

• Standard protocol for monitoring based on FDA approved medication will be followed