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

This study has been terminated.
Sponsor:
Collaborators:
Assistance Publique - Hôpitaux de Paris
University of Ulm
Aventis Pharmaceuticals
Information provided by:
King's College London
ClinicalTrials.gov Identifier:
NCT00211224
First received: September 13, 2005
Last updated: December 14, 2005
Last verified: September 2005
  Purpose

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
Multiple System Atrophy
Progressive Supranuclear Palsy
Drug: Riluzole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 3 Study of Riluzole in Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP) (Parkinson's Plus Syndromes)

Resource links provided by NLM:


Further study details as provided by King's College London:

Primary Outcome Measures:
  • survival

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

Estimated Enrollment: 800
Study Start Date: April 2000
Estimated Study Completion Date: November 2004
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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211224

Locations
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
Investigators
Principal Investigator: Peter N Leigh, PhD FRCP King's College London
  More Information

No publications provided by King's College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00211224     History of Changes
Other Study ID Numbers: QLG1-2000-01262, European Commission, QLG1-2000-01262
Study First Received: September 13, 2005
Last Updated: December 14, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by King's College London:
multiple system atrophy
progressive supranuclear palsy
riluzole
MSA
PSP

Additional relevant MeSH terms:
Parkinson Disease
Multiple System Atrophy
Shy-Drager Syndrome
Supranuclear Palsy, Progressive
Atrophy
Paralysis
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurologic Manifestations
Eye Diseases
Signs and Symptoms
Pathological Conditions, Anatomical
Riluzole
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 20, 2014