A combination trial of Copaxone plus Estriol in relapsing-remitting Multiple Sclerosis
Recruitment Period:
June 2007- ongoing
Location of Study/Trial :
Dartmouth-Hitchcock Medical Center,
One Medical Center Drive,
Lebanon, NH 03756
Recruiting:
Females 18-50 with relapsing-remitting MS, who are able to walk without any assistive aids such as a cane or walker, and have had at least one relapse within the last 2 years.
Disqualification criteria
- Women who are pregnant and/or breast-feeding
- Smokers
- Women who have other serious medical conditions
Principal Investigator:
Vijay M. Thadani
Director, Dartmouth-Hitchcock Medical Center, MS Center.
Sponsor:
funded by the National MS Society and the National Institutes of Health.
Description of Study/Trial:
The purpose of this study is to determine if the use of oral Estriol in combination with Copaxone injections is safe; if the use of combination treatment causes a decrease in relapse rates; if there is more rapid improvement on brain MRI with the combination treatment; if there is an improvement in disability measures with the combination treatment.
Subjects will be seen by neurologists, gynecologists and for cognitive testing during the study visits, which will be over 24 months.
Subjects will be required to travel to Dartmouth-Hitchcock medical center for appointments.