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Neuroprotection and Natural History in Parkinson's Plus Syndromes (NNIPPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00211224
Recruitment Status : Terminated
First Posted : September 21, 2005
Last Update Posted : December 15, 2005
Assistance Publique - Hôpitaux de Paris
University of Ulm
Aventis Pharmaceuticals
Information provided by:
King's College London

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple System Atrophy Progressive Supranuclear Palsy Drug: Riluzole Phase 3

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase 3 Study of Riluzole in Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP) (Parkinson's Plus Syndromes)
Study Start Date : April 2000
Study Completion Date : November 2004

Primary Outcome Measures :
  1. survival

Secondary Outcome Measures :
  1. functional measures (UPDRS, Parkinson's Plus Scale)
  2. Change in MRI abnormalities
  3. Cognitive changes

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • akinetic rigid syndrome plus clinical criteria for MSA or PSP

Exclusion Criteria:

  • Idiopathic Parkinson's disease
  • Other neurological or serious medical disorders
  • Unable to give informed consent
  • dementia
  • liver damage
  • women of child bearing age unable to use effective method of contraception

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00211224

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United Kingdom
Institute of Psychiatry, King's College London
London, United Kingdom, SE58AF
Sponsors and Collaborators
King's College London
Assistance Publique - Hôpitaux de Paris
University of Ulm
Aventis Pharmaceuticals
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Principal Investigator: Peter N Leigh, PhD FRCP King's College London
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00211224    
Other Study ID Numbers: QLG1-2000-01262
European Commission
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 15, 2005
Last Verified: September 2005
Keywords provided by King's College London:
multiple system atrophy
progressive supranuclear palsy
Additional relevant MeSH terms:
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Multiple System Atrophy
Shy-Drager Syndrome
Supranuclear Palsy, Progressive
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Vascular Diseases
Cardiovascular Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs