Infusion of Apomorphine: Long-term Safety Study

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: US WorldMeds LLC
• Treatments: Apomorphine

Criteria

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