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Apomorphine Effects on Pain in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Apomorphine Injectable Solution
Placebo
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Movement Disorder Program, Foothills Medical Center, Alberta Health ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Apomorphine Injections

Placebo Injections

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Number of adverse events
Adverse events assessed for safety purposes at each study visit.

Full Information

First Posted
May 4, 2021
Last Updated
May 16, 2022
Sponsor
University of Calgary
Collaborators
Paladin Labs Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04879134
Brief Title
Apomorphine Effects on Pain in Parkinson's Disease
Official Title
Apomorphine Effect on Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
Paladin Labs Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
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
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apomorphine Injections
Arm Type
Experimental
Arm Title
Placebo Injections
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Apomorphine Injectable Solution
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
0.9% saline placebo injection Other Names: • Saline
Primary Outcome Measure Information:
Title
Changes in Unified Parkinson Disease Rating Scale
Description
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.
Time Frame
0, 1 and 2 weeks
Title
Change in Likert Visual Analogue Scale
Description
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.
Time Frame
0, 1 and 2 weeks
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression Scale
Description
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.
Time Frame
0, 1 and 2 weeks
Title
Number of adverse events
Description
Adverse events assessed for safety purposes at each study visit.
Time Frame
0, 1 and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Bruno, MD, MPH
Phone
403-220-7572
Email
veronica.bruno@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Beatrice Anghelescu
Phone
403-220-7572
Email
bamanghe@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Bruno, MD, MPH
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Movement Disorder Program, Foothills Medical Center, Alberta Health Services
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Bruno, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Apomorphine Effects on Pain in Parkinson's Disease

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