Parkinson's DiseasePDComNCT00443768
Medication Review in Patients on Anti-parkinson Therapy
An observational study of Parkinson's Disease, run by South Glasgow University Hospitals NHS Trust at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2006to Aug 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Community sample of Parkinson's disease patients
Who may be able to join
- 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.
Who cannot join
- Patients on anti-parkinson medication for reasons other than Parkinson's disease.
- Patients with significant co-morbidity (end stage liver, cardiac or renal disease).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southern General Hospital
Glasgow, Scotland, G51 4TF
About this study
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
Read the 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
- Keywords
- Medication, Diagnosis, Community
- Medical subject headings
- Parkinson Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startOct 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Glasgow University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Donald Grosset, South Glasgow University Hospitals NHS Trust
- Investigators
- Donald Grosset, MD, Study chair, Dept of Neurology, INS, Southern General HospitalEdward Newman, MRCP, Principal investigator, Dept of Neurology, INS, Southern General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443768
- Sponsor's protocol ID
- R060112/SW
- Acronym
- PDCom
- Status last verified
- Feb 2013
- First submitted
- 2 Mar 2007
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Review in Patients on Anti-parkinson Therapy
- ClinicalTrials.gov ID
- NCT00443768
- Acronym / sponsor ID
- PDCom / R060112/SW
- Conditions
- Parkinson's Disease
- Keywords
- Medication, Diagnosis, Community
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- South Glasgow University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 6 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community sample of Parkinson's disease patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients on anti-parkinson medication for reasons other than Parkinson's disease.
- Patients with significant co-morbidity (end stage liver, cardiac or renal disease).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Grosset, MD study chair
Dept of Neurology, INS, Southern General Hospital
Edward Newman, MRCP principal investigator
Dept of Neurology, INS, Southern General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by South Glasgow University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.