This study is in progress, not accepting new patients

Infusion of Apomorphine: Long-term Safety Study

a study on Parkinson's Disease

Summary

Eligibility
for people ages 30 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Jeff Bronstein (ucla)

Description

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.

Official Title

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

Details

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.

Keywords

Idiopathic Parkinson's Disease, Parkinson's disease,, apomorphine, Apokyn, dopamine agonist, levodopa, advanced, PD, carbidopa, pramipexole, ropinirole, rotigotine, MAO-B inhibitors, COMT inhibitors, off, dyskinesia, Parkinson Disease, apomorphine infusion

Eligibility

You can join if…

Open to people ages 30 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Los Angeles California 90095 United States
  • Los Angeles California 90033 United States

Lead Scientist at University of California Health

  • Jeff Bronstein (ucla)
    Jeff Bronstein, M.D., Ph.D., holds the Fred Silton Family Chair in Movement Disorders.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
ID
NCT02339064
Phase
Phase 3 Parkinson's Disease Research Study
Study Type
Interventional
Participants
About 99 people participating
Last Updated