Status:
TERMINATED
An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis
Lead Sponsor:
Neurognostics
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-65 years
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 ...
Detailed Description
The development of the immunomodulatory, disease-modifying therapies (DMT) represents a major advance for the treatment of multiple sclerosis (MS). To date, immunomodulatory agents approved for the tr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00398528
Start Date
September 1 2006
End Date
November 1 2007
Last Update
December 5 2007
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Southern California
Los Angeles, California, United States, 90033
2
Minor & James Medical
Seattle, Washington, United States, 98104
3
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53792
4
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215