Status:

COMPLETED

European Compliance Study in Parkinson's Disease

Lead Sponsor:

South Glasgow University Hospitals NHS Trust

Conditions:

Parkinson's Disease

Eligibility:

All Genders

18-80 years

Brief Summary

In both symptomatic and asymptomatic disease, only about half of medicines are taken as prescribed1. Relatively little is known about how patients with Parkinson's disease take their medication. One o...

Detailed Description

This is an observational study of how patients with Parkinson's disease take their medication. Antiparkinson medication will be monitored using electronic pill bottles, MEMS, Aardex®, Switzerland (whi...

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 :

January 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2007

Estimated Enrollment :

144 Patients enrolled

Trial Details

Trial ID

NCT00466739

Start Date

January 1 2006

End Date

September 1 2007

Last Update

May 23 2008

Active Locations (1)

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1

Dr D Grosset

Glasgow, United Kingdom, G51 4TF