Apomorphine Effects on Pain in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Apomorphine Effect on Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Cross-over Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879134
• Other study ID #: REB20-0423
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 28, 2022
• Est. completion date: July 2023

Study information

• Verified date: May 2022
• Source: University of Calgary
• Contact: Veronica Bruno, MD, MPH
• Phone: 403-220-7572
• Email: veronica.bruno[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Apomorphine Injectable Solution
Patients will receive the treatment while they are in an OFF period, without the effect of any antiparkinsonian medication. For this study, the initial dose of apomorphine or placebo will be 2 mg. We selected an initial standardized dose based on the pharmacological characteristics of apomorphine. Assessments will be completed 30 and 60 minutes after the initial dose. At 60 minutes from the first dose, a 3 mg dose will be administered, and again, assessments will be completed after 30 and 60 minutes. The total given dosage will be 5 mg. Blood pressure and pulse will be checked every 20 minutes after injections. Other Names: Movapo
• Placebo
0.9% saline placebo injection Other Names: • Saline

Locations

Country	Name	City	State
Canada	Movement Disorder Program, Foothills Medical Center, Alberta Health Services	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	Paladin Labs Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Unified Parkinson Disease Rating Scale	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.	0, 1 and 2 weeks
Primary	Change in Likert Visual Analogue Scale	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.	0, 1 and 2 weeks
Secondary	Change in Clinical Global Impression Scale	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.	0, 1 and 2 weeks
Secondary	Number of adverse events	Adverse events assessed for safety purposes at each study visit.	0, 1 and 2 weeks