Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Multiple Sclerosis
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.
Interventions
DRUGCCI-779
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term safety. | — |
| Listing and summary tables of AE and TEAEs, vital signs, laboratory evaluations, and ECG data will be generated. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
| Only descriptive statistics will be performed. | — |
Outcome results
None listed