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Neuroprotection and natural history in parkinson plus syndromes: a clinical trial of the efficacy and safety of riluzole in parkinson plus syndromes

Objective

The Parkinson-Plus syndromes, Multiple System Atrophy and Progressive Supranuclear Palsy (MSA & PSP) are rapidly progressive neurodegenerative diseases, leading to severe disability and death. They are orphan diseases with neither symptomatic nor curative therapy. We will
(i) establish whether the antiexcitotoxic drugriluzole can slow the disease progression,
(ii) provide for the first time prospective data on their natural history. In U. K., France, and Germany, 800patients, stratified on MSA or PSP, will randomly be assigned to placebo orriluzole and followed double blind for 36 months. The primary efficacy criterionis survival.
The project will validate diagnostic staging, new assessment instruments and disease severity staging;
assess cognitive function, quality of life and health economics;
and establish DNA and tissue banks for basic research.
The project will comply with the GMP, GCP, GLP and GSP specifications.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

KING'S COLLEGE LONDON
Address
De Crespigny Park, Denmark Hill
SE5 8AF London
United Kingdom

Participants (5)

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
France
Address
Avenue Victoria 3
75004 Paris
AVENTIS PHARMA DEUTSCHLAND GMBH
Germany
Address
Industriepark Hoechst
65926 Frankfurt Am-main
AVENTIS PHARMA LTD
United Kingdom
Address
50 Kings Hill Avenue, Kings Hill West Malling
ME19 4AH West Malling
LABORATOIRE AVENTIS
France
Address
Rue De La Vanne, 15
92545 Montrouge
UNIVERSITY OF ULM
Germany
Address
Steinhövelstrasse 9
89070 Ulm