Apomorphine Effects on Pain in Parkinson's Disease

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the effects of acute apomorphine vs. placebo administration on different Parkinson's disease pain types.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary
• Collaborator: Paladin Labs Inc.
• Treatments: Apomorphine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.