Adherence of Stalevo, Entacapone and Levodopa - Tabular View

Tracking Information

First Received Date ^ICMJE

October 27, 2005

Last Updated Date

May 22, 2008

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00245700 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Adherence of Stalevo, Entacapone and Levodopa

Official Title ^ICMJE

Study of Adherence of Stalevo, Entacapone and Levodopa

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Other

Condition ^ICMJE

Parkinson's Disease

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00245700

Responsible Party

Dr D Grosset, Southern General Hospital

Study ID Numbers ^ICMJE

R050017, Grant from Orion Pharma

Study Sponsor ^ICMJE

South Glasgow University Hospitals NHS Trust

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Donald G Grosset, MBChB, MD

Unaffiliated

Information Provided By

South Glasgow University Hospitals NHS Trust

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP