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

USWM-AP2-3000

This is a Phase 3, multicenter, open-label, safety and tolerability study of continuous apomorphine infusion in subjects with advanced Parkinson's Disease (PD) whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD.

2015-02-01

2018-12-01

2024-12-01

Active (not recruiting)

Early phase I

99

Inclusion Criteria: * Advanced idiopathic PD consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria * Overall motor control is unsatisfactory in the opinion of the Investigator and subject despite optimized treatment with available therapies, which must include a stable regimen of daily maintenance levodopa (or levodopa/carbidopa), and at least one of the following other classes of therapies: * Dopamine agonists (note: APOKYN intermittent injection is not to be considered here) * Monoamine oxidase B \[MAO B\] inhibitors * Catechol-O-methyltransferase (COMT) inhibitors * Deep brain stimulation (DBS) * Levodopa/carbidopa intestinal gel surgery (Duopa, Duodopa) * Other - amantadine at doses of up to 400 mg per day) * Experiences "off" periods averaging ≥3.0 hours per waking day * Other criteria will be discussed in detail with potential subjects by site Investigator Exclusion Criteria: * Planned surgical intervention for the treatment of Parkinson's disease during participation in the study * History of hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN PFS, including sodium metabisulfite * Known, suspected, or planned pregnancy or lactation. * Recent history (within the previous 12 months) of alcohol or substance abuse * History of impulsive/compulsive behaviors primarily associated with the use of dopamine agonists * History of previously treated or current diagnosis of malignant melanoma * Exhibits certain signs and symptoms of cardiovascular disease * Other criteria will be discussed in detail with potential subjects by site Investigator

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 99, 'type': 'ACTUAL'}}

2024-04-25