Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's Disease
NCT ID: NCT02469090
Last Updated: 2020-07-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
141 participants
INTERVENTIONAL
2015-06-18
2017-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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APL-130277
APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
APL-130277
Use to treat up to 5 "OFF" episodes per day
Placebo
Matching placebo for APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
Placebo
placebo
Interventions
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APL-130277
Use to treat up to 5 "OFF" episodes per day
Placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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CNS Medical Director
Role: STUDY_DIRECTOR
Sumitomo Pharma America, Inc.
Locations
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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
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Jefferson University Hospital Philadelphia
Philadelphia, Pennsylvania, United States
University of Virginia, Adult Neurology
Charlottesville, Virginia, United States
Evergreen Health
Kirkland, Washington, United States
UHN Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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References
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Olanow CW, Factor SA, Espay AJ, Hauser RA, Shill HA, Isaacson S, Pahwa R, Leinonen M, Bhargava P, Sciarappa K, Navia B, Blum D; CTH-300 Study investigators. Apomorphine sublingual film for off episodes in Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 study. Lancet Neurol. 2020 Feb;19(2):135-144. doi: 10.1016/S1474-4422(19)30396-5. Epub 2019 Dec 7.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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CTH-300
Identifier Type: -
Identifier Source: org_study_id
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