Status:
COMPLETED
AT RISK FOR MS - Clinical Conversion of Female Monozygotic Twins Discordant for CIS/MS
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Multiple Sclerosis Society
Conditions:
Multiple Sclerosis
Clinically Isolated Syndrome
Eligibility:
FEMALE
10-45 years
Brief Summary
The definition of the most 'at-risk' population within highly susceptible groups would provide an opportunity for preemptive therapeutics. A convenient, safe, and tolerable therapy that delays the on...
Detailed Description
Primary Objective: Determine if the presence of characteristic MS-like lesion(s) on baseline MRI predisposes to CIS/MS in female MZ twins discordant for CIS/MS. Secondary Objective: Define the protei...
Eligibility Criteria
Inclusion
- 'at risk' individuals for MS - female co-twins discordant for CIS/MS.
- 'at risk' individuals for MS who at the time of randomization have not converted to MS or CIS.
- 'at risk' individuals will be treatment-naïve for immunomodulatory/suppressive medications.
- \< 46 years old.
Exclusion
- Individuals diagnosed with MS or CIS.
- Other 'at risk' individuals who do not conform to the specific 'at risk' groups outlined above e.g., 1st degree, 2nd degree and 3rd degree relative of MS index cases.
- Subjects over 45.
- Use of immunomodulatory medications such as azathioprine, gold, sulfasalazine, minocycline, statins, and MTX or prednisone \> 7.5 mg/day within 30 days of randomization for any reason.
- Active drug use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements or a psychiatric disorder that is unstable or would preclude reliable participation in the study.
- Serious illness (requiring systemic treatment and/or hospitalization) such as diabetes mellitus, renal, cardiac, or pulmonary disease. Subjects with a history of alcoholism, or in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol, or participation in the treatment and evaluation program.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00617383
Start Date
February 1 2008
End Date
December 1 2010
Last Update
April 4 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas - Houston
Houston, Texas, United States, 77030