Apomorphine Effects on Pain in Parkinson's Disease

Phase 2

• Conditions: Parkinson Disease
• Interventions: Drug: Placebo; Drug: Apomorphine Injectable Solution

• Registration Number: NCT04879134
• Lead Sponsor: University of Calgary

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 disease, such as urinary disturbances and sleep. Apomorphine is usually well tolerated as it produces limited side effects. Knowledge about the effects of apomorphine on pain in PD is scarce. Evidence on this topic has only been reported in case reports or small studies but represents a potentially important use of the drug. We hypothesize that apomorphine may be a rational, safe, and useful treatment for subjects with pain in PD, including different subtypes. Within this framework, the present study will evaluate the effect of acute apomorphine vs. placebo administration on different PD pain types.

Study Timeline

• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-10
• Study Start: 2022-02-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18
• Primary Completion: 2023-02
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Injections	Placebo	-
Apomorphine Injections	Apomorphine Injectable Solution	-

Primary Outcome Measures

Name	Time	Method
Changes in Unified Parkinson Disease Rating Scale	0, 1 and 2 weeks	Measures changes of symptom severity, treatment response and the efficacy of treatments. Part 1 (non-motor experiences of daily living), Part 2 (motor experiences of daily living), Part 3 (motor examination) and Part 4 (motor complications). The maximum score for all the parts is 272. Higher scores are indicative of worse outcomes.
Change in Likert Visual Analogue Scale	0, 1 and 2 weeks	The measure of global pain change perceived by the patients. The most simple Likert Visual Analogue Scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). There are no numerical values on this scale however, a positioning towards the left of the scale indicates a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	0, 1 and 2 weeks	Adverse events assessed for safety purposes at each study visit.
Change in Clinical Global Impression Scale	0, 1 and 2 weeks	Changes in scores on the Clinical Global Impression (CGI) scale. CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).CGI scores range from 1 (very much improved) through to 7 (very much worse). Treatment response ratings should take account of both therapeutic efficacy and treatment-related adverse events and range from 0 (marked improvement and no side-effects) and 4 (unchanged or worse and side-effects outweigh the therapeutic effects). Each component of the CGI is rated separately; the instrument does not yield a global score.

Trial Locations

Locations (1)

Movement Disorder Program, Foothills Medical Center, Alberta Health Services; 🇨🇦 Calgary, Alberta, Canada