Conditions: Multiple Sclerosis Cognitive Impairment
Keywords: Multiple Sclerosis Cognition Rivastigmine Patch
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 86
Healthy volunteers: no

Brief summary:
This study evaluated the efficacy and safety of 10 cm² rivastigmine patch vs. placebo in cognitively impaired Multiple Sclerosis (MS) patients. Primary objective was the assessment of cognition by the Selective Reminding Test (SRT) -a subtest of the brief repeatable battery (BRB) - after titration of 4 weeks and maintenance of 12 weeks. This double-blind period was followed by a 52-week open-label treatment phase to assess long-term safety of rivastigmine patch in these patients.

Detailed description:

Arms:
arm 1: Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size. arm 2: Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size.

Interventions: intervention 1: Rivastigmine transdermal patch intervention 2: Placebo
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol document: