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

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ClinicalTrials.gov Identifier: NCT00443768
Recruitment Status : Completed
First Posted : March 6, 2007
Last Update Posted : February 4, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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

Condition or disease
Parkinson's Disease

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 Design

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Medication Review in Patients on Anti-parkinson Therapy
Study Start Date : October 2006
Primary Completion Date : August 2008
Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample of Parkinson's disease patients

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).
Contacts and Locations

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): NCT00443768

United Kingdom
Southern General Hospital
Glasgow, Scotland, United Kingdom, G51 4TF
Sponsors and Collaborators
South Glasgow University Hospitals NHS Trust
Study Chair: Donald Grosset, MD Dept of Neurology, INS, Southern General Hospital
Principal Investigator: Edward Newman, MRCP Dept of Neurology, INS, Southern General Hospital
More Information

Responsible Party: Dr Donald Grosset, Consultant Neurologist, South Glasgow University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00443768     History of Changes
Other Study ID Numbers: R060112/SW
First Posted: March 6, 2007    Key Record Dates
Last Update Posted: February 4, 2013
Last Verified: February 2013

Keywords provided by Dr Donald Grosset, South Glasgow University Hospitals NHS Trust:

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases