Status:
UNKNOWN
Apomorphine Effects on Pain in Parkinson's Disease
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Paladin Labs Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
To study the effects of acute apomorphine vs. placebo administration on different Parkinson's disease pain types.
Detailed Description
Apomorphine is the only anti-parkinsonian agent compatible with levodopa in improving Parkinson's disease (PD) motor symptoms. Besides, it has positive effects on some of the nonmotor symptoms of the ...
Eligibility Criteria
Inclusion
- Subjects with PD according to the MDS Clinical diagnostic criteria for Parkinson's disease.
- Participants on antiparkinsonian medication in advanced stages of the disease and experiencing OFF periods and pain.
- Apomorphine treatment naïve subjects or not received any within the last six months.
- Stable PD and pain medications for at least 30 days.
- Competence to self-report pain severity in the King's Parkinson's disease Pain Scale and a Likert Visual Analogue Scale.
Exclusion
- Subjects who are unable to self-report pain severity in the selected scales. Patients that may require a translator or are illiterate will be included if they can self-report pain severity.
- Subjects with a diagnosis of dementia (Montreal Cognitive Assessment \<20).
- Subject with poorly controlled orthostatic hypotension.
- Subjects associated with another medical condition, e.g., any cardiovascular, renal or hepatic impairment, hematological or psychiatric diseases.
- Any contraindication to receiving apomorphine injections:
- Subjects who are hypersensitive to apomorphine or any ingredient in the formulation or component of the container (hydrochloric acid concentrated, sodium bisulfite (E222), and water)
- Subjects using concomitant drugs of the 5HT3 antagonist class including (e.g., ondansetron, granisetron, palonosetron)
- Subjects using concomitant antihypertensive medications or vasodilators
- Subjects with prolonged QT on an electrocardiogram.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04879134
Start Date
February 28 2022
End Date
July 1 2023
Last Update
May 18 2022
Active Locations (1)
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1
Movement Disorder Program, Foothills Medical Center, Alberta Health Services
Calgary, Alberta, Canada, T2N4N1