Title of project or programme
Title of PI A large randomised assessment of the relative cost-effectiveness of different classes of drugs for Parkinson’s disease (PD MED)
Principal Investigators of project/programme grant
Title Forname Surname Institution Country
Professor Richard Gray University of Birmingham United Kingdom
Address of institution of lead PI
Institution University of Birmingham
Street Address Aston Webb Building, B’Block
City Birmingham
Postcode B15 2TT
Country
  • United Kingdom
Source of funding information

Department of Health (DH)

Total sum awarded (Euro)

1876454

Start date of award

01-11-1999

Total duration of award in months

144

The project/programme is most relevant to
  • Parkinson’s disease
Keywords

Parkinson Disease

Research abstract in English

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.

Lay summary

Parkinson’s disease is a movement disorder that causes stiffness in the muscles, slowness, and tremor. These symptoms appear over many years and are caused by a reduction in the numbers of brain cells that produce a chemical called dopamine.

Several different types of drugs (mainly levodopa, dopamine agonists, MAOB inhibitors and COMT inhibitors) are used to control the symptoms of PD, with some doctors preferring one type and other doctors another.

However, little is known about how the drugs compare with each other and whether or not some provide better overall quality of life for people with PD. The only reliable way to find out which treatment achieves the best control of symptoms with the fewest side-effects is through what is called a clinical trial weighing up all of the advantages and disadvantages of each type of drug and seeing which is best overall.

PD MED is a large national clinical trial comparing the different drugs for PD. Patients who agree to take part are allocated, at random, to be treated with one or other of the different types of drug. These are prescribed by their doctor in the usual way and the patient is asked to complete questionnaires every year, for at least 5 years, to say how the drugs are affecting them. The patient’s carer, if they have one, is also asked how helping to look after someone with PD affects their life. The questionnaires are sent out by post and no extra clinic visits are necessary.

The study started in November 2000 and first results are expected in 2006. PD MED is organised by the University of Birmingham Clinical Trials Unit, and funded by the NHS Health Technology Assessment programme. No companies are involved.

Further information is available from the PD MED study office, BCTU, 1 Somerset Rd, Birmingham B15 2RR, tel: 0121 687 2315, or by e-mail from pd-trials@bctu.bham.ac.uk or from the PD MED website www.bctu.bham.ac.uk

In which category does this research fall?
  • Clinical research

    Principal Investigators

    Gray, Richard

    Institution

    University of Birmingham

    Contact information of lead PI

    Country

    United Kingdom

    Title of project or programme

    A large randomised assessment of the relative cost-effectiveness of different classes of drugs for Parkinson's disease (PD MED)

    Source of funding information

    NIHR

    Total sum awarded (Euro)

    € 3,363,030

    Start date of award

    01/11/1999

    Total duration of award in years

    17.0

    The project/programme is most relevant to:

    Parkinson's disease and PD-related disorders

    Keywords

    Parkinson| drug therapy

    Research Abstract

    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.

    Lay Summary

    Parkinson’s disease is a movement disorder that causes stiffness in the muscles, slowness, and tremor. These symptoms appear over many years and are caused by a reduction in the numbers of brain cells that produce a chemical called dopamine. Several different types of drugs (mainly levodopa, dopamine agonists, MAOB inhibitors and COMT inhibitors) are used to control the symptoms of PD, with some doctors preferring one type and other doctors another. However, little is known about how the drugs compare with each other and whether or not some provide better overall quality of life for people with PD. The only reliable way to find out which treatment achieves the best control of symptoms with the fewest side-effects is through what is called a clinical trial weighing up all of the advantages and disadvantages of each type of drug and seeing which is best overall. PD MED is a large national clinical trial comparing the different drugs for PD. Patients who agree to take part are allocated, at random, to be treated with one or other of the different types of drug. These are prescribed by their doctor in the usual way and the patient is asked to complete questionnaires every year, for at least 5 years, to say how the drugs are affecting them. The patient’s carer, if they have one, is also asked how helping to look after someone with PD affects their life. The questionnaires are sent out by post and no extra clinic visits are necessary. The study started in November 2000 and first results are expected in 2006. PD MED is organised by the University of Birmingham Clinical Trials Unit, and funded by the NHS Health Technology Assessment programme. No companies are involved. Further information is available from the PD MED study office, BCTU, 1 Somerset Rd, Birmingham B15 2RR, tel: 0121 687 2315, or by e-mail from pd-trials@bctu.bham.ac.uk or from the PD MED website www.bctu.bham.ac.uk

    Further information available at:

Types: Investments > €500k
Member States: United Kingdom
Diseases: Parkinson's disease & PD-related disorders
Years: 2011
Database Categories: N/A
Database Tags: N/A

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