|
ISRCTN
|
ISRCTN69812316
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A large randomised assessment of the relative cost-effectiveness of different classes of drugs for Parkinson's disease (PD)
|
|
Scientific title
|
|
|
Acronym
|
PDMED
|
|
Serial number at source
|
HTA 98/03/02
|
|
Study hypothesis
|
Clinical trials comparing different classes of Parkinson's disease drugs have been too small for reliable conclusions, have used inappropriate surrogate endpoints, and follow-up has been too short to evaluate long-term benefits and toxicity. This large (5000 patients), pragmatic, 'real-life' randomised trial addresses four fundamental, unanswered questions about PD treatment: what are the costs and benefits of: LD-sparing therapy (DA or MAOB inhibitors) compared to LD alone in initial treatment; DAs compared to MAOB inhibitors as initial LD-sparing therapy; DAs compared to DDIs (COMT or MAOB inhibitors) when motor fluctuations develop on LD alone; COMT inhibitors compared to MAOB inhibitors as DDI in advanced disease. Two separate 3-way randomisations allow classes of treatments for early and advanced disease to be investigated. Secondary objectives are to identify factors that might predict response to particular classes of drug and to provide a large collaborative framework within which other studies - in particular of neurosurgery and genetics - can be undertaken.
|
|
Ethics approval
|
Not provided at time of registration.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Nervous system diseases: Parkinson's disease
|
|
Participants - inclusion criteria
|
Recently diagnosed patients with PD and patients with poorly controlled PD
|
|
Participants - exclusion criteria
|
Not provided at time of registration.
|
|
Anticipated start date
|
01/11/1999
|
|
Anticipated end date
|
31/10/2011
|
|
Status of trial
|
Ongoing
|
|
Patient information material
|
|
|
Target number of participants
|
5000
|
|
Interventions
|
Please note that, as of 16 January 2008, the anticipated end date of this trial has been updated from 31 October 2004 to 31 October 2011.
Interventions:
New vs old drugs for PD
|
|
Primary outcome measure(s)
|
PDQ-39 and EuroQol EQ-5D ( Activities of Daily Living and Quality of life), caregiver wellbeing, time to treatment failure, long-term toxicity, formal and informal care costs. A cost-minimisation (if no clinical difference) or cost-utility (cost/QALY) analysis will be undertaken.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration.
|
|
Sources of funding
|
NIHR Health Technology Assessment Programme - HTA (UK)
|
|
Trial website
|
http://www.pdmed.bham.ac.uk/
|
|
Publications
|
|
|
Contact name
|
Prof
Richard
Gray
|
|
Address
|
University of Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B15 2RR
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)121 415 9100
|
|
Fax
|
+44 (0)121 687 2313
|
|
Email
|
r.gray@bham.ac.uk
|
|
Sponsor
|
University of Birmingham (UK)
|
|
Address
|
Edgbaston
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B15 2TT
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.bham.ac.uk/
|
|
Date applied
|
25/04/2003
|
|
Last edited
|
22/01/2008
|
|
Date ISRCTN assigned
|
25/04/2003
|
