Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Parkinson Disease, Off Episodes

In brief

A 12-week, prospective, multi-center, randomized, double-blind, placebo controlled, Phase 3 study in L-Dopa responsive PD patients with motor fluctuations ("OFF" episodes), designed to determine the efficacy, safety and tolerability of APL-130277.

Key facts

Study ID

NCT02469090

Run by

Sumitomo Pharma America, Inc.

People needed

141

Starts

2015-06-18

Expected to finish

2017-12-11

Last updated by the study team

2020-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ≥ 18 years of age.
• Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria.
• Clinically meaningful response to L-Dopa with well-defined early morning "OFF" episodes, as determined by the Investigator.
• Receiving stable doses of L-Dopa/carbidopa (immediate or CR) administered at least 4 times per day OR Rytary™ administered 3 times per day, for at least 4 weeks before the initial Screening Visit
• No planned medication change(s) or surgical intervention anticipated during the course of study.
• Patients must experience at least one well defined "OFF" episode per day with a total daily "OFF" time duration of ≥ 2 hours during the waking day, based on patient self-assessment.
• Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
• MMSE score > 25.

You may not qualify if…

• A patient will not be eligible for study entry if any of the following exclusion criteria are met:
• Atypical or secondary parkinsonism.
• Previous treatment with any of the following: a neurosurgical procedure for PD; continuous s.c. apomorphine infusion; or Duodopa/Duopa.
• Treatment with any form of s.c. apomorphine within 7 days prior to the initial Screening Visit (SV1). Patients that stopped s.c. apomorphine for any reason other than systemic safety concerns or lack of efficacy may be considered.
• Contraindications to APOKYN®, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN® (notably sodium metabisulfite); Tigan® (trimethobenzamide hydrochloride; patients from US sites only); or domperidone (patients from non-US sites only).
• Participation in a clinical trial within 30 days prior to the initial Screening Visit (SV1).
• Currently taking selective 5HT3 antagonists (i.e., ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents.
• Drug or alcohol dependency in the past 12 months.
• History of malignant melanoma.
• Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
• Major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
• History of clinically significant hallucinations during the past 6 months.
• History of clinically significant impulse control disorder(s).
• Dementia that precludes providing informed consent or would interfere with participation in the study.

Where it is running

• University of Alabama, Birmingham — Birmingham, Alabama, United States
• Muhammed Ali Parkinson and Movement Disorder CenterBarrow Neurological — Phoenix, Arizona, United States
• Movement Disorders Center of Arizona — Scottsdale, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• The Parkinson's and Movement Disorder Institute — Fountain Valley, California, United States
• UC Irvine Health Gottschalk Medical Plaza — Irvine, California, United States
• Keck Medical Center at USC — Los Angeles, California, United States
• The Research Center of Southern California — Oceanside, California, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Parkinsons Disease and Movement Disorders Center — Boca Raton, Florida, United States
• University of Miami, Miller School of Medicine — Miami, Florida, United States
• Parkinson's Disease Treatment Center of Southwest Florida — Port Charlotte, Florida, United States
• USF Parkinson's Disease and Movement Disorder Center — Tampa, Florida, United States
• Emory University Department of Neurology — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Central DuPage Hospital - Neurodegenerative Clinic - Movement Disorders Center — Winfield, Illinois, United States
• Kansas University Medical Center - Department of Neurology — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• QUEST Research Institute — Farmington Hills, Michigan, United States
• Northern Michigan Neurology — Traverse City, Michigan, United States
• Henry Ford Hospital — West Bloomfield, Michigan, United States
• Columbia University Medical Center - Neurological Institute, Movement Disorders — New York, New York, United States
• Raleigh Neurology Associates, P.A. — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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