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Sponsors and Collaborators: |
King's College London Assistance Publique - Hôpitaux de Paris University of Ulm Aventis Pharmaceuticals |
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Information provided by: | King's College London |
ClinicalTrials.gov Identifier: | NCT00211224 |
NNIPPS is a clinical trial of riluzole (a drug previously shown to slow down the rate of progression og amyotrophic lateral sclerosis-ALS; Lou Gehrig's disease) involving nearly 800 people diagnosed with the 'parkinson plus' syndromes of multiple system atrophy (MSA) and progressive supranuclear plasy (PSP). In addition to showing whether riluzole is helpful in MSA and PSP, NNIPPS will improve criteria for making an accurate and early diagnosis, for assessing the rate of progression, and will advance understanding of the biology of these disabling and progressive neurodegenerative diseases.
Condition | Intervention | Phase |
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Multiple System Atrophy Progressive Supranuclear Palsy |
Drug: Riluzole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Study of Riluzole in Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP) (Parkinson's Plus Syndromes) |
Estimated Enrollment: | 800 |
Study Start Date: | April 2000 |
Estimated Study Completion Date: | November 2004 |
Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP) often present as akinetic-rigid syndromes and in the early stages are difficult to differentiate in the clinic. Current Consensus Diagnostic Criteria based on retrospective studies have high specificity but low sensitivity. The NNIPPS study is an EU-funded multinational (France, UK, Germany) multi-centre academic-led project with four main aims. The first aim is to test the hypothesis that riluzole, which may have generic neuroprotective properties, reduces the risk of death and improves function and quality of life (QL) in patients with MSA and PSP- ‘parkinson’s plus syndromes’. The second aim is to identify prognostic factors for survival and functional deterioration, and to develop and validate functional rating scales prospectively. The third aim is to investigate MRI, cognitive, pathological and genetic aspects of these disorders in relation to disease progression and pathogenesis. The fourth aim is to understand the impact of these diseases on the QL of patients and carers and to identify the health costs of treatment.
The study is designed as a randomised, stratified, controlled trial of the efficacy and safety of riluzole (up to 200mg daily) versus placebo in MSA and PSP. The primary outcome measure is survival at 36 months. Power calculations suggested that we would need to recruit ~400 patients into each stratum (MSA, PSP) in order to detect a reduction in the relative risk (RR) of death at 36 months with 80% power and two-sided a=0.05. Using modified consensus criteria (to provide greater sensitivity) we recruited 766 patients (363 PSP, 404 MSA) over 2 years (1999-2001). The first patients recruited are about to enter the open-label study. The final analysis of the primary efficacy measure is planned for December 2005. Secondary outcome measures include safety, rate of change in UPDRS and other rating scales including a parkinson’s plus symtoms rating scale (PPSS), changes in cognitive function assessed using the Mattis Dementia Rating Scale, the Frontal Assessment Battery, The Bushke Selective Reminding Test, The Neuropsychiatric Inventory, and other tests of memory and executive function. QL and Health economic data is collected using the SF36 and a Client Service Receipt Inventory (CSRI). Assessments are made at 6 monthly intervals. Standardised MRI has been acquired in ~70% of cases at entry and will be repeated at 36 months where possible. DNA has been collected from ~75% of cases. 100 brains have been donated and are being analysed using a standardised protocol.
Ages Eligible for Study: | 30 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Institute of Psychiatry, King's College London | |
London, United Kingdom, SE58AF |
Principal Investigator: | Peter N Leigh, PhD FRCP | King's College London |
Study ID Numbers: | QLG1-2000-01262, European Commission, QLG1-2000-01262 |
Study First Received: | September 13, 2005 |
Last Updated: | December 14, 2005 |
ClinicalTrials.gov Identifier: | NCT00211224 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
multiple system atrophy progressive supranuclear palsy riluzole MSA PSP |
Riluzole Multiple system atrophy Pathological Conditions, Anatomical Excitatory Amino Acids Motor neuro-ophthalmic disorders Ganglion Cysts Eye Diseases Basal Ganglia Diseases Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases |
Ocular motility disorders Paralysis Signs and Symptoms Ocular Motility Disorders Multiple System Atrophy Parkinson Disease Movement Disorders Progressive supranuclear palsy Supranuclear Palsy, Progressive Neurologic Manifestations Atrophy |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Excitatory Amino Acid Agents Ophthalmoplegia Neuroprotective Agents Protective Agents |
Pharmacologic Actions Therapeutic Uses Cranial Nerve Diseases Tauopathies Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |