Study Evaluating CCI-779 in Relapsing Multiple Sclerosis

NCT00228397

Last updated date
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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Relapsing-Remitting Multiple Sclerosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Advanced Information
Descriptive Information
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
 (submitted: February 11, 2013)
221
Original Enrollment  ICMJE
 (submitted: September 16, 2005)
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:

  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
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