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Adherence of Stalevo, Entacapone and Levodopa

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245700
First Posted: October 28, 2005
Last Update Posted: May 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
South Glasgow University Hospitals NHS Trust
  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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245700


Locations
United Kingdom
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
  More Information

Responsible Party: Dr D Grosset, Southern General Hospital
ClinicalTrials.gov Identifier: NCT00245700     History of Changes
Other Study ID Numbers: R050017
Grant from Orion Pharma
First Submitted: October 27, 2005
First Posted: October 28, 2005
Last Update Posted: May 23, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Levodopa
Entacapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors