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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00211224 |
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Date of registration:
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13/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Neuroprotection and Natural History in Parkinson's Plus Syndromes (NNIPPS)
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Scientific title:
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Phase 3 Study of Riluzole in Multiple System Atrophy (MSA) and Progressive Supranuclear Palsy (PSP) (Parkinson's Plus Syndromes) |
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Date of first enrolment:
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April 2000 |
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Target sample size:
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800 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00211224 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Peter N Leigh, PhD FRCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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King's College London |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Progressive Supranuclear Palsy
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Multiple System Atrophy
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Intervention(s)
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Drug: Riluzole
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Primary Outcome(s)
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survival
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Secondary Outcome(s)
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functional measures (UPDRS, Parkinson's Plus Scale)
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Cognitive changes
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Change in MRI abnormalities
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Secondary ID(s)
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European Commission
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QLG1-2000-01262
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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