Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211224
Status:
TERMINATED
Last Update Posted:
2005-12-15
First Post:
2005-09-13
Brief Title:
Neuroprotection and Natural History in Parkinsons Plus Syndromes NNIPPS
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Phase 3 Study of Riluzole in Multiple System Atrophy MSA and Progressive Supranuclear Palsy PSP Parkinsons Plus Syndromes
Status:
TERMINATED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Gehrigs 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- parkinsons 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 a005 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 parkinsons 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
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 a005 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 parkinsons 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| QLG1-2000-01262 | None | None | None |
| European Commission | None | None | None |