Adherence of Stalevo, Entacapone and Levodopa

This study has been completed.

First Received: October 27, 2005 Last Updated: May 22, 2008 History of Changes

Sponsored by:	South Glasgow University Hospitals NHS Trust
Information provided by:	South Glasgow University Hospitals NHS Trust
ClinicalTrials.gov Identifier:	NCT00245700

Purpose

To test if combining two antiparkinson drugs into a single tablet improves accuracy of medicine intake by the patient.

To test if patients with Parkinson's disease who take medicines at regular time intervals have smoother symptom control.

Condition
Parkinson's Disease

Study Type:	Observational
Official Title:	Study of Adherence of Stalevo, Entacapone and Levodopa

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

Drug Information available for: Levodopa OR 611 Entacapone

U.S. FDA Resources

Further study details as provided by South Glasgow University Hospitals NHS Trust:

Estimated Enrollment:	14
Study Start Date:	April 2005
Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients diagnosed with Parkinson's disease aged between 18 and 85 years fulfilling UK Brain Bank criteria.
Current levodopa therapy prescribed on a regular basis three or more times per day but requiring entacapone because of 'wearing off'
Able to manipulate electronic monitoring bottles and complete questionnaires

Exclusion Criteria:

Current use of compliance aid such that study participation would be detrimental to patient's adherence
Pregnancy or breast feeding
Excess alcohol (over 21 units per week for women and 28 units for men)
Mini mental state examination of less than 26.
Severe depression (Geriatric depression score over 20)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245700

Locations

United Kingdom, Scotland
Southern General Hospital
Glasgow, Scotland, United Kingdom, G51 4TF

Sponsors and Collaborators

South Glasgow University Hospitals NHS Trust

Investigators

Principal Investigator:

Donald G Grosset, MBChB, MD

Unaffiliated

More Information

No publications provided

Responsible Party:	Southern General Hospital ( Dr D Grosset )
Study ID Numbers:	R050017, Grant from Orion Pharma
Study First Received:	October 27, 2005
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00245700 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Levodopa
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases
Entacapone

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Basal Ganglia Diseases
Nervous System Diseases
Central Nervous System Diseases
Antiparkinson Agents
Enzyme Inhibitors
Brain Diseases

Neurodegenerative Diseases
Pharmacologic Actions
Entacapone
Parkinson Disease
Movement Disorders
Therapeutic Uses
Parkinsonian Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009