Study Evaluating CCI-779 in Relapsing Multiple Sclerosis
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Listing and summary tables of AE and TEAEs, vital signs, laboratory evaluations, and ECG data will be generated.
Secondary Outcome Measures
Preliminary efficacy of long-term treatment.
Lesions observed on MRI scans, clinical measures such as the EDSS scale, the 9-Hole Peg Test, the Paced Auditory Serial Addition Test and the Timed Ambulation 25-Foot Test, occurrence of relapse, will be analyzed at end -point (12 or 16 months).
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects with relapsing-remitting MS or secondary progressive MS with relapses.
Successful completion of study 3066A2-205-WW with no major protocol violations.
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.