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A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase

A 16-week, multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the efficacy of rivastigmine (Exelon® patch 10 cm2) on cognitive deficits in patients with multiple sclerosis, followed by a 1-year open-label treatment phase
CompletedPhase 3MS (type not specified)2008-007015-32

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Rivastigmine

    Cholinesterases; ACHE & BCHE inhibitor

What it measured

Main measures

  • The primary endpoint is the change in score of total recall on the SRT (baseline to week 16). The SRT is a widely used measure of verbal learning and memory that is part of the Brief Repeatable Battery of Neuropsychological Test in MS (BRB-N).

    Thinking and memory

Who could take part

MS (type not specified)

Inclusion: 1) Written informed consent to participate in the trial Exclusion: 1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

To demonstrate that rivastigmine patch (target patch size 10 cm²) has superior efficacy compared to placebo on a change from baseline of the total recall score of the selective reminding test (SRT) of the Brief Repeatable Battery of Neuropsychological Tests (BRB-N) in cognitive impaired MS patients after 16 weeks of treatment.

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History

    1. Started

      Mar 2009

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