Apomorphine Effects on Pain in Parkinson's Disease

NCT ID: NCT04879134

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2023-07-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Apomorphine Injections

Group Type: EXPERIMENTAL

Apomorphine Injectable Solution

Intervention Type: DRUG

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 Injections

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% saline placebo injection

Other Names:

• Saline

Interventions

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

Intervention Type: DRUG

Placebo

0.9% saline placebo injection

Other Names:

• Saline

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paladin Labs Inc.

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Veronica Bruno

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronica Bruno, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Movement Disorder Program, Foothills Medical Center, Alberta Health Services

Calgary, Alberta, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Veronica Bruno, MD, MPH

Role: CONTACT

veronica.bruno@ucalgary.ca

403-220-7572

Beatrice Anghelescu

Role: CONTACT

bamanghe@ucalgary.ca

403-220-7572

Facility Contacts

Veronica Bruno, MD, MPH

Role: primary

Other Identifiers

REB20-0423

Identifier Type: -

Identifier Source: org_study_id