A Phase 3, Open-Label Study of the Safety, Efficacy, and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients with Unsatisfactory Control on Available Therapy (Infusion)
Brief description of study
We are asking you to be part of this research study because you have Parkinson’s disease (PD). By doing this study, we hope to learn more about the long-term safety of Apomorphine Continuous Infusion (APOKYN® PFS) in patients with advanced PD. APOKYN® (apomorphine hydrochloride injection) is a new formulation of an already FDA approved drug. This is a drug that already being used to treat Parkinson’s Disease (PD) via a “subcutaneous injection”, meaning a short needle is used to inject the medication into the tissue layer in between the skin and the muscle. This study aims to evaluate a new delivery system (continuous infusions) for the already approved medication. The continuous infusion aims to administer the apomorphine hydrochloride under the skin via a constant low level of drug introduced through a small needle in your abdomen [stomach]. This new delivery system is considered “investigational” because it has not yet been approved by the FDA.
Detailed description of study
Study visits: Screening Period (up to 35 days duration); Baseline Period (at least 14 days, within the 35-day Screening Period); Dose Initiation and Titration Period (4-6 clinic visits within a 51-day window; in addition, up to 3 unscheduled visits will be permitted during that window); Treatment Maintenance Period (52 weeks per subject, with visit intervals of 2 to 8 weeks); and Treatment Extension Period (visits will occur at 6-month intervals until study drug becomes commercially available or the study is stopped, per Sponsor discretion). The following will be performed for the purposes of this research study and are not considered standard care: Use of apomorphine hydrochloride injection Extra blood draws and clinic visits; Extra pregnancy testing; Extra ECG recordings; Dermatologic exams for melanoma (skin cancer); and Completion of multiple questionnaires and scales by you (caregiver, if applicable) and study staff. During this study, you will not be permitted to begin any additional treatment for PD. You will be receiving 2 drugs during this research study: apomorphine hydrochloride (study drug) and trimethobenzamide (drug to prevent nausea and vomiting).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Parkinson's disease, Dyskinesias, parkinson's disease
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Age: Between 30 Years - 100 Years
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Gender: All
Updated on
04 Apr 2024.
Study ID: 825082
