Apomorphine Effects on Pain in Parkinson's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Parkinson Disease
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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: Triple (Participant, Care Provider, Investigator)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 groupsPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 produce...
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.
Tracking Information
- NCT #
- NCT04879134
- Collaborators
- Paladin Labs Inc.
- Investigators
- Principal Investigator: Veronica Bruno, MD, MPH University of Calgary
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