Status:
COMPLETED
Electronic Compliance Monitoring in Parkinson's Disease
Lead Sponsor:
South Glasgow University Hospitals NHS Trust
Collaborating Sponsors:
Neurosciences Foundation
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Patients with Parkinson's Disease (PD) depend on medication for relief of motor symptoms, and for this reason are often assumed to medicate very carefully. Overall, medication adherence is very good, ...
Detailed Description
Patients attending a regional movement disorder clinic with idiopathic PD (by UK Brain Bank criteria) and prescribed one or more antiparkinson drug (including dopamine agonist or levodopa) were invite...
Eligibility Criteria
Inclusion
- Men or Women between 18 and 80 years.
- Patient has idiopathic Parkinson's Disease according to Brain Bank criteria. Reference Hughes A J, Daniel S E, Kilford L, Lees A J, Accuracy of Clinical Diagnosis of Idiopathic Parkinson's disease; A clinical Pathological study of 100 cases, JNNP 1992, 55(3): 181 - 184
- Patient is on stable doses of anti-Parkinson's disease medication, which are not expected to change during the study period.
- Patient is taking levodopa and/or dopamine agonist treatment.
- Patient (assisted by a carer where appropriate) is able to take their medication using the MEMS (electronic monitoring) containers.
- Patients using a dosette box or similar device for their medication are willing to use the MEMS containers for their PD medication
- The investigator judges that the patient's care and symptom control will not be adversely affected by entering the study and using the MEMS device.
Exclusion
- Patient is taking anti-Parkinson's disease therapy intermittently or on "as required" basis (such as rescue therapy for off periods). Intermittent Domperidone is allowed.
- Severe co-morbid condition such as severe heart, liver, or kidney disease or cancer diagnosis where the co-morbid condition is of greater health significance than the Parkinson's disease in terms of life expectancy and levels of care required.
- Patient is expected to undergo hospital admission during the study period (such as elective surgery).
- Patient is on non standard drug treatment / combination therapy. This would include e.g. a combination of 2 different oral dopamine agonists, doses of dopamine agonist taken at higher than recommended for routine practice.
- New antiparkinson treatment is being introduced at the time of recruitment or during the one month monitoring period.
- Patient is taking only adjunct therapy (eg. Selegiline, Amantadine, anticholinergic therapy).
- Patient is taking part in a clinical trial.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00361205
Start Date
November 1 2003
End Date
September 1 2005
Last Update
October 17 2006
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