Rivastigmine in Multiple Sclerosis Patients With Cognitive Impairment (EXCITING)
|ClinicalTrials.gov Identifier: NCT00881205|
Recruitment Status : Terminated (Termination of study due to low enrollment)
First Posted : April 15, 2009
Results First Posted : February 24, 2012
Last Update Posted : March 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Cognitive Impairment||Drug: Rivastigmine transdermal patch Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Rivastigmine Patch (10 cm²) on Cognitive Deficits in Patients With Multiple Sclerosis, Followed by a 1-year Open-label Treatment Phase|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
U.S. FDA Resources
Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.
Drug: Rivastigmine transdermal patch
Transdermalapplication of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. All patches are round, beige in color.
Placebo Comparator: Placebo
Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.
Transdermal application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. Matching the size, shape and color of rivastigmine patches.
- Change From Baseline to Week 16 in Total Recall on the Selective Reminding Test (SRT) in the Intent to Treat (ITT) Population [ Time Frame: After 16 weeks of treatment ]The Selective Reminding Test(SRT) is a test to assess verbal learning and memory. During the administration of the SRT only the examiner and the patient should be in the testing room. A list of twelve words is read aloud by the examiner at a rate of one word per two seconds. The patient is asked to recall all twelve words. Only the words that are missed on the preceding trial are given in the consecutive trial. The total score represents a sum score of 6 trials, therefore the range is from 0-72. The lower the value the worse the outcome.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881205
Show 49 Study Locations
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|