Parkinson's disease Nervous System Diseases Parkinson's disease
Conditions
Interventions
Current interventions as of 05/05/2009:
Early PD randomisation
Patients with early PD are randomised between DA (+/- LD), MAOBI (+/- LD) and LD alone, with the option
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/04/2009: Patients are eligible for the early disease randomisation if: 1. They are newly or recently diagnosed with Parkinson's disease. It is important to ensure the accurate diagnosis of PD and the UK Brain Bank criteria should be used 2. They have functional disability requiring medical therapy. Patients not thought to require dopaminergic treatment at diagnosis may be entered once it is considered that such treatment becomes necessary 3. They are previously untreated for PD or have been treated with dopaminergic PD medication for less than 6 months 4. There is no definite contraindication to, or definite indication for, any of the therapies to which they might be allocated (If it is considered that LD only is not an appropriate option for a patient, they may be randomised two ways between DA and MAOBI. Similarly, if a MAOBI is not considered appropriate, a patient may be randomised two ways between LD and DA.) 5. They are able to complete the trial questionnaires. Non-English-speaking patients may be entered if they have a carer, relative or other person who can help them fill in the questionnaires, or if translated documentation is available Patients are eligible for the later disease randomisation if: 1. They have PD and develop motor complications that are uncontrolled by LD (either alone or in combination with either a DA or a MAOBI) and hence require the addition of another class of drug 2. There is no definite contraindication to, or definite indication for, any of the therapies to which they might be allocated. (Patients who were already receiving a DA when uncontrolled motor fluctuations arose are not eligible for the DA arm and will be randomised between MAOBI and COMTI only. Patients who were receiving a MAOBI when uncontrolled motor fluctuations arose, or for whom the clinician does not wish a MAOBI to be an option, are not eligible for the MAOBI arm and will be randomised between DA and COMTI only.) 3. They are able to complete the trial questionnaires. Non-English-speaking patients may be entered if they have a carer, relative or other person who can help them fill in the questionnaires, or if translated documentation is available. Previous inclusion criteria: Recently diagnosed patients with PD and patients with poorly controlled PD
Exclusion criteria
Exclusion criteria: Added as of 21/04/2009: Patients are not eligible for the early disease randomisation if: 1. They have received previous dopaminergic drug therapy for PD for more than 6 months 2. They are demented (as defined by the medical team responsible) 3. They are unable to give informed consent Patients are not eligible for the later disease randomisation if: 1. They are demented (as defined by the medical team responsible) 2. They are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 21/04/2009: 1. Patient's self-evaluation of their functional status and quality of life (using the Parkinson's Disease Questionnaire 39 [PDQ-39]) 2. Cost-effectiveness (EuroQoL EQ-5D) All primary outcome measures will be assessed at baseline, 6 months and then at 1, 2, 3, 4 and 5 years. Previous primary outcome measures: 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
| Measure | Time frame |
|---|---|
| Added as of 21/04/2009: 1. Cognitive function (Mini Mental State Examination [MMSE]), assessed at baseline and 5 years 2. Wellbeing of carers (SF-36® Health Survey), assessed at baseline, 6 months and then at 1, 2, 3, 4 and 5 years 3. Resource usage, followed-up for 5 years 4. Toxicity and side-effects, including mortality rates, followed-up for 5 years 5. Time to onset of motor complications (early disease randomisation only) and time to surgical intervention or start of apomorphine (later disease randomisation only), followed-up for 5 years | — |
Countries
England, United Kingdom
Outcome results
None listed