A Phase 2/3 interventional study of Apomorphine Injectable Solution and Placebo in Parkinson Disease, sponsored by University of Calgary. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of Calgary · Phase 2/3, Interventional, and Treatment
To study the effects of acute apomorphine vs. placebo administration on different Parkinson's disease pain types.
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.
4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University of Calgary is the lead sponsor of 686 studies on the registry; 189 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
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Exclusion Criteria:
Any contraindication to receiving apomorphine injections:
Drug: Apomorphine Injectable Solution
Drug: Placebo
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
0.9% saline placebo injection Other Names: • Saline
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.
Time frame: 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.
Time frame: 0, 1 and 2 weeks
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.
Time frame: 0, 1 and 2 weeks
Number of adverse events
Adverse events assessed for safety purposes at each study visit.
Time frame: 0, 1 and 2 weeks
Plan to share: No
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University of Calgary