Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT04879134
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04879134
Study Brief:
Protocol Section:
NCT04879134