European Compliance Study in Parkinson's Disease

NCT00466739 | Completed

• 1 other identifier: 05/S0709/95
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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 of the challenges in the management of Parkinson's disease is the prevention and treatment of involuntary movements2,3 and wild fluctuations between being mobile and able to function against being slow, stiff and unable to move which recurs as a delayed (several years) effect of taking antiparkinson medication. One theory of why this occurs is that it is due to pulsatile rather than continuous delivery of medication to the brain4. If patients take their medicines erratically and irregularly, this causes more fluctuations in blood and therefore brain drug levels may prime patients for complications in the future. This project will define the extent of irregular medication taking in Parkinson's disease, examine associated clinical and demographic characteristics and examine the ease of adherence to different drug regimes. Knowledge of therapy adherence will help support patients in using their medicines to best effect. In the present document the terms compliance and adherence are used with equal meaning.

Conditions

Parkinson's Disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Glasgow University Hospitals NHS Trust: lead

Study Sites (1)

Dr D Grosset

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Donald Grosset, MD

  Southern General Hospital, Glasgow, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: January 1, 2006
• Study Completion: September 1, 2007
• Last Updated: May 23, 2008

Record last verified: 2008-05

Locations

GB (1)