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.
What it found
We found no results in the registry or in papers.
This trial finished 21 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Temsirolimus
FK506-binding protein 1A inhibitor
What it measured
Main measures
Long-term safety.
SafetyListing and summary tables of AE and TEAEs, vital signs, laboratory evaluations, and ECG data will be generated.
Safety
Other measures (3)
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).
Disability progressionRelapsesMRI lesionsOnly descriptive statistics will be performed.
Who could take part
Relapsing and progressive
Show the full criteria
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Nov 2003
Main results due
Nov 2005
Finished
Nov 2005