Medication Review in Patients on Anti-parkinson Therapy

Parkinson's Disease Clinical Trial

— PDCom  

Official title:

Medication Review in Patients on Anti-parkinson Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443768
• Other study ID #: R060112/SW
• Status: Completed
• Phase: N/A
• First received: March 2, 2007
• Last updated: February 1, 2013
• Start date: October 2006
• Est. completion date: August 2008

Study information

• Verified date: February 2013
• Source: South Glasgow University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Scotland: Scottish Executive Health Department
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
United Kingdom	Southern General Hospital	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
South Glasgow University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom,