University of Birmingham
A large randomised assessment of the relative cost-effectiveness of different classes of drugs for Parkinson's disease (PD MED)
Parkinson's disease & PD-related disorders
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 patient), 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.