Back to resultsAdherence of Stalevo, Entacapone and Levodopa
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Parkinson's Disease
Eligibility 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)
Sites / Locations
- Southern General Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00245700
First Posted
October 27, 2005
Last Updated
May 22, 2008
Sponsor
South Glasgow University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT00245700
Brief Title
Adherence of Stalevo, Entacapone and Levodopa
Official Title
Study of Adherence of Stalevo, Entacapone and Levodopa
Study Type
Observational
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
South Glasgow University Hospitals NHS Trust
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Enrollment
14 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald G Grosset, MBChB, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern General Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Adherence of Stalevo, Entacapone and Levodopa
We'll reach out to this number within 24 hrs