Medication Review in Patients on Anti-parkinson Therapy (PDCom)

February 1, 2013 updated by: Dr Donald Grosset, South Glasgow University Hospitals NHS Trust
To identify patients within the community taking anti-parkinson medications in whom the diagnosis of Parkinson's disease is incorrect and to supervise and clinically monitor the withdrawal of anti-parkinson medications in this patient group

Study Overview

Status

Completed

Conditions

Detailed Description

Step 1 - Practice based pharmacist and medical review using database search for the following:

  • Anti-parkinson drug therapy (excluding anticholinergic monotherapy).
  • Disease codes to identify Parkinson's disease and parkinsonism, and exclude other diagnoses where anti-parkinson therapy may be used, although both are expected to be very small numbers (pituitary tumour, restless leg syndrome)
  • To identify the duration of parkinsonism from the date of entry of the disease code.
  • Pharmacy re-fill data to identify intermittent usage of treatment as an indicator of it being unlikely that the patient has idiopathic or dopa responsive parkinsonism.
  • To identify patients on monotherapy with anti-parkinson therapy e.g. Selegiline for a prolonged duration as this is likely to suggest an alternative diagnosis.
  • To record drug dosage over time, e.g. on an annual basis, again to identify whether patients fit in with the expected rates of change for degenerative parkinsonism where increasing combinations of drugs at higher doses are used over time.

Step 2 - Review of case records:

· Parkinson's disease nurse specialist and medical review of case records to identify additional clinical features of the condition and assist in identifying cases where it appears likely that anti-parkinson drug treatment is not helping the patient's condition.

Step 3 - Specialist out-patient review and follow-up:

· Invitation to the patient to attend the combined neurology/medicine for the elderly movement disorder clinic service where scoring against diagnostic clinical criteria would be undertaken, and where appropriate tapering of anti-parkinson therapy gradually under continued specialist observation.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
        • Southern General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Community sample of Parkinson's disease patients

Description

Inclusion Criteria:

Patients on anti-parkinson medication who:

  • Have been on monotherapy for a prolonged period, or
  • Use anti-parkinson medications intermittently, or
  • Do not have the expected change in medication over time in keeping with degenerative Parkinson's disease.

Exclusion Criteria:

  • Patients on anti-parkinson medication for reasons other than Parkinson's disease.
  • Patients with significant co-morbidity (end stage liver, cardiac or renal disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Glasgow University Hospitals NHS Trust

Investigators

  • Study Chair: Donald Grosset, MD, Dept of Neurology, INS, Southern General Hospital
  • Principal Investigator: Edward Newman, MRCP, Dept of Neurology, INS, Southern General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 2, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

February 1, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R060112/SW

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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