drugset

drugset / Trial / NCT00977665

Clinical Trial to Assess Efficacy, Safety, and Tolerability of Rasagiline Mesylate 1 mg in Patients With Multiple System Atrophy of the Parkinsonian Subtype (MSA-P)

NCT00977665 ↗

Phase 2 Completed 174 enrolled Teva Branded Pharmaceutical Products R&D, Inc. H. Lundbeck A/S · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To test the clinical effect of rasagiline on subjects with MSA of the parkinsonian subtype.

Timeline

Start: 2009-12
Primary completion: 2011-10
Completion: 2011-10

Outcome

Missed primary endpoint

paper This treatment difference of -0·60 (95% CI -3·68 to 2·47; p=0·70) was not significant. PMID 25498732 ↗

paper treatment with rasagiline 1 mg per day did not show a significant benefit as assessed by UMSARS. PMID 25498732 ↗

Publications

Poewe W, Seppi K, Fitzer-Attas CJ, Wenning GK, Gilman S, Low PA, Giladi N, Barone P, Sampaio C, Eyal E, Rascol O; Rasagiline-for-MSA investigators. Efficacy of rasagiline in patients with the parkinsonian variant of multiple system atrophy: a randomised, placebo-controlled trial. Lancet Neurol. 2015 Feb;14(2):145-52. doi: 10.1016/S1474-4422(14)70288-1. Epub 2014 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rasagiline	Small molecule	1 mg	—

Indications