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Adherence of Stalevo, Entacapone and Levodopa

NCT ID: NCT00245700

Last Updated: 2008-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Glasgow University Hospitals NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Southern General Hospital

Principal Investigators

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Donald G Grosset, MBChB, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Southern General Hospital

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Grant from Orion Pharma

Identifier Type: -

Identifier Source: secondary_id

R050017

Identifier Type: -

Identifier Source: org_study_id