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Adherence of Stalevo, Entacapone and Levodopa

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ClinicalTrials.gov Identifier: NCT00245700
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : May 23, 2008
Sponsor:
Information provided by:
South Glasgow University Hospitals NHS Trust

Study Description
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Brief Summary:

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 or disease
Parkinson's Disease

Study Design
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Study Type : Observational
Enrollment : 14 participants
Official Title: Study of Adherence of Stalevo, Entacapone and Levodopa
Study Start Date : April 2005
Actual Study Completion Date : July 2006

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: October 28, 2005    Key Record Dates
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