Apomorphine Effects on Pain in Parkinson's Disease

NCT04879134 | Unknown Phase 2

• 1 other identifier: REB20-0423
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in Clinical Global Impression Scale

  0, 1 and 2 weeks

• Number of adverse events

  0, 1 and 2 weeks

Study Arms (2)

Apomorphine Injections

EXPERIMENTAL

Drug: Apomorphine Injectable Solution

Placebo Injections

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Apomorphine Injectable Solution 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

Apomorphine Injections

Placebo DRUG

0.9% saline placebo injection Other Names: • Saline

Placebo Injections

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Paladin Labs Inc.: collaborator

Study Sites (1)

Movement Disorder Program, Foothills Medical Center, Alberta Health Services

Calgary, Alberta, T2N4N1, Canada

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Veronica Bruno, MD, MPH

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Bruno, MD, MPH

CONTACT

403-220-7572; veronica.bruno@ucalgary.ca

Beatrice Anghelescu

CONTACT

403-220-7572; bamanghe@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Upon entry to the study, all subjects will be assigned to a subject number. Eligible subjects will be randomized to receive either apomorphine injections or placebo on VISIT 2 in a double-blind manner according to a randomization schedule using computerized randomization tables prepared by a blinded clinical nurse. Participants will then cross over to the other treatment group to receive apomorphine or placebo injections on VISIT 3. The specific type of randomization used will be block randomization to ensure equal sample sizes of the apomorphine and placebo groups
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: We will perform a small pilot double-blind, randomized cross-over study evaluating the safety and efficacy of apomorphine injections vs. placebo injections on pain in PD. Subjects, caregivers, and investigators will be blinded to the assignment.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 10, 2021
• Study Start: February 28, 2022
• Primary Completion: February 1, 2023
• Study Completion: July 1, 2023
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)