Medication Review in Patients on Anti-parkinson Therapy

NCT ID: NCT00443768

Last Updated: 2013-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-08-31

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

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.

Conditions

Parkinson's Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

No interventions assigned to this group

2

No interventions assigned to this group

Eligibility Criteria

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Glasgow University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Dr Donald Grosset

Consultant Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donald Grosset, MD

Role: STUDY_CHAIR

Dept of Neurology, INS, Southern General Hospital

Edward Newman, MRCP

Role: PRINCIPAL_INVESTIGATOR

Dept of Neurology, INS, Southern General Hospital

Locations

Southern General Hospital

Glasgow, Scotland, United Kingdom

Countries

United Kingdom

Other Identifiers

R060112/SW

Identifier Type: -

Identifier Source: org_study_id