Study Evaluating CCI-779 in Relapsing Multiple Sclerosis

A Multicenter, Randomized, Double-blind, Long-term Extension Study to Determine the Safety, Tolerability, and Preliminary Efficacy of CCI-779 in Subjects With Relapsing Multiple Sclerosis.

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.

Inclusion Criteria:

• Subjects with relapsing-remitting MS or secondary progressive MS with relapses.
• Successful completion of study 3066A2-205-WW with no major protocol violations.

Exclusion Criteria:

• 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.