Status:
COMPLETED
fMRI Study of Treatment Recommendations Comparing Recently Diagnosed Multiple Sclerosis (MS) Patients to Controls
Lead Sponsor:
Waukesha Memorial Hospital
Collaborating Sponsors:
The Cleveland Clinic
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
- Inclusion Criteria MS Subjects:
- 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 in accordance with the refined McDonald • Diagnosed with Relapsing-Remitting Multiple Sclerosis for ≤ 1 year
- Naive to disease-modifying treatments
- Expanded Disability Status Score (EDSS) of 0 to ≤ 5.5, inclusive
- Willingness and ability to comply with the protocol for the duration of the study
- If female, she must either:
- be post-menopausal or surgically sterilized; or
- use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and
- be neither pregnant nor breast-feeding.
- confirmation that if the subject can still have children, that she is not pregnant must be established by a negative urine pregnancy test within 30 days of Study Day o.
- Exclusion Criteria - MS Subjects:
- Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception
- Progressive forms of MS (Primary progressive, Secondary progressive)
- Subjects who have been on DMTs or other previous treatment for MS
- 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.
- 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 either 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 \>2.5 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
- Subjects whose high-resolution anatomic MR scans reveal the presence of a structural abnormality (other than MS)
- 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
- Standard protocol for monitoring based on FDA approved medication will be followed
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00391352
Start Date
February 1 2008
End Date
August 1 2012
Last Update
June 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Waukesha Memorial Hospital ProHealth Care
Waukesha, Wisconsin, United States, 53188