Recruiting
Phase 2
Phase 3

Apomorphine

Sponsor:

University of Calgary

Code:

NCT04879134

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Apomorphine Injectable Solution

Placebo

Study Details

Brief summary:

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

Conditions

Parkinson Disease

Study ID

NCT04879134

Start date

Feb 28, 2022

Status verified date

May, 2022

Completion date

Jul, 2023

Anticipated

Primary completion date

Feb, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Apomorphine Injections

placebo comparator: Placebo Injections

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

Placebo

0.9% saline placebo injection

Other Names:

• Saline

Primary outcome measure

  • Changes in Unified Parkinson Disease Rating Scale [ Time Frame: 0, 1 and 2 weeks ]
  • Change in Likert Visual Analogue Scale [ Time Frame: 0, 1 and 2 weeks ]

Central Contacts and Locations

Central contacts

Veronica Bruno, MD, MPH

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

Beatrice Anghelescu

403-220-7572bamanghe@ucalgary.ca

Locations

Movement Disorder Program, Foothills Medical Center, Alberta Health Services

Recruiting

Calgary, Alberta, Canada, T2N4N1

More Information

Sponsor

University of Calgary

Last update posted

May 18, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2022-05-18.