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

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Brief Title

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

Official Title

Phase 3 Study of Riluzole in Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP) (Parkinson's Plus Syndromes)

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.
    

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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

survival

Secondary Outcome

 functional measures (UPDRS, Parkinson's Plus Scale)

Condition

Multiple System Atrophy

Intervention

Riluzole


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

800

Start Date

April 2000

Completion Date

November 2004


Eligibility 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
      

Gender

All

Ages

30 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Peter N Leigh, PhD FRCP, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT00211224

Organization ID

QLG1-2000-01262

Secondary IDs

European Commission


Study Sponsor

King's College London

Collaborators

 Assistance Publique - Hôpitaux de Paris

Study Sponsor

Peter N Leigh, PhD FRCP, Principal Investigator, King's College London


Verification Date

September 2005