Study Evaluating CCI-779 in Relapsing Multiple Sclerosis
NCT00228397
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating CCI-779 in Relapsing Multiple Sclerosis | |||
Official Title ICMJE | 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. | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Primary Purpose: Treatment | |||
Condition ICMJE | Multiple Sclerosis, Relapsing-Remitting | |||
Intervention ICMJE | Drug: CCI-779 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 221 | |||
Original Enrollment ICMJE | 200 | |||
Actual Study Completion Date ICMJE | November 2005 | |||
Actual Primary Completion Date | November 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00228397 | |||
Other Study ID Numbers ICMJE | 3066A2-210 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |