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Study Evaluating CCI-779 in Relapsing Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00228397
First received: September 16, 2005
Last updated: February 11, 2013
Last verified: February 2013
History of Changes

September 16, 2005
February 11, 2013
November 2003
November 2005   (final data collection date for primary outcome measure)
  • Long-term safety.
  • Listing and summary tables of AE and TEAEs, vital signs, laboratory evaluations, and ECG data will be generated.
Same as current
Complete list of historical versions of study NCT00228397 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Multiple Sclerosis, Relapsing-Remitting
Drug: CCI-779
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
November 2005
November 2005   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00228397
3066A2-210
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP