Status:
COMPLETED
Study Evaluating CCI-779 in Relapsing Multiple Sclerosis
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
To evaluate the safety and tolerability of long-term therapy with 3 dose levels of oral CCI-779 administered to subjects with relapsing MS who completed study 3066A2-205-WW.
Eligibility Criteria
Inclusion
- Subjects with relapsing-remitting MS or secondary progressive MS with relapses.
- Successful completion of study 3066A2-205-WW with no major protocol violations.
Exclusion
- Pregnancy or lactation.
- Clinically important abnormalities on the physical examination, vital signs, or electrocardiogram (ECG) performed at the last visit of study 3066A2-205-WW (day 252).
- Any adverse events or findings observed in study 3066A2-205-WW that in the opinion of the investigators would preclude the subject's entry into the extension study.
- Please refer to section 16.2 'Discontinuation and Withdrawal of Subjects' regarding withdrawal of patients who have any clinical abnormalities in hematology or laboratory test results obtained at the last visit of the double-blind active phase of study 3066A2-205-WW.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00228397
Start Date
November 1 2003
End Date
November 1 2005
Last Update
February 13 2013
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