Infusion of Apomorphine: Long-term Safety Study (INFUS-ON)

MDD US Operations

Status and phase

Active, not recruiting

Phase 3

Conditions

Idiopathic Parkinson's Disease

Treatments

Drug: apomorphine infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT02339064

USWM-AP2-3000

Details and patient eligibility

About

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.

Full description

This Phase 3, multicenter, open-label study will assess the long-term safety and tolerability of continuous subcutaneous infusion of apomorphine in advanced Parkinson's disease (PD) patients whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for PD.

Further, this study will assess the clinical effectiveness of continuous apomorphine subcutaneous infusion in reducing "off" time in advanced PD patients and to assess the clinical effectiveness of continuous subcutaneous infusion of apomorphine in improving "on" time without resulting in an increase in troublesome dyskinesias.

Enrollment

99 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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