Infusion of Apomorphine: Long-term Safety Study



Status:Active, not recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - Any
Updated:3/8/2019
Start Date:February 2015
End Date:October 2019

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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

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.

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.

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
We found this trial at
16
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West Bloomfield, Michigan 48322
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