| Source of record | UK Trials |
| ISRCTN | ISRCTN69812316 |
| Date ISRCTN assigned | 25/04/2003 |
| Local reference number(s) | HTA 98/03/02 |
| 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 |
| Disease/condition/study domain | Nervous system diseases: Parkinson's disease |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Recently diagnosed patients with PD and patients with poorly controlled PD |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/11/1999 |
| Anticipated end date | 31/10/2011 |
| Status of trial | Ongoing |
| 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. |
| Trial website | http://www.pdmed.bham.ac.uk/ |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Sponsor name | University of Birmingham (UK) |
| Sponsor details | Edgbaston
Birmingham
United Kingdom
B15 2TT |
| Sponsor website | http://www.bham.ac.uk/ |
| Contact name | Prof Richard Gray |
| Contact details | University of Birmingham Clinical Trials Unit
University of Birmingham
Park Grange
1 Somerset Road
Edgbaston
Birmingham
United Kingdom
B15 2RR |
| Contact telephone | +44 (0)121 415 9100 |
| Contact fax | +44 (0)121 687 2313 |
| Contact email | r.gray@bham.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN69812316 |
| Date last extracted from ISRCTN register | 17/04/2008 |
