Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease

NCT02542696 | Completed Phase 3 Results DMC

• 2 other identifiers: CTH-3012016-000637-43
• Study Type: interventional
• Target: 496
• Locations: 8 countries
• Sites: 70

Brief Summary

An Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients With Parkinson's Disease

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of Safety and Tolerability Data Collected, Based on Number of Participants With Adverse Events in the LTS Phase

  Number of Participants (%) with Adverse Events in the LTS Phase

  up to approximately 3 years

Secondary Outcomes (18)

• The Percentage of Instances Where a Full "ON" Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 24 Visit (LTS V4) of the LTS Phase Based on the Home Dosing Diary Entries.

  Week 24

• The Percentage of Instances Where a Full "ON" Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 36 Visit (LTS V5) of the LTS Phase Based on the Home Dosing Diary Entries.

  Week 36

• The Percentage of Instances Where a Full "ON" Response Was Achieved Within 30 Minutes After Self-administration of Study Medication at Week 48 Visit (LTS V6) of the LTS Phase Based on the Home Dosing Diary Entries.

  Week 48

• Percentage of Subjects With a Subject-rated Full "ON" Response Within 30 Minutes at Week 24 Visit (LTS V4) of the LTS Phase.

  Week 24

• Percentage of Subjects With a Subject-rated Full "ON" Response Within 30 Minutes at Week 36 Visit (LTS V5) of the LTS Phase.

  Week 36

Study Arms (1)

APL-130277

EXPERIMENTAL

APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)

Drug: APL-130277

Interventions

APL-130277 DRUG

Used to treat up to 5 "OFF" episodes per day

Also known as: Apomorphine Hydrochloride, Sublingual Thin Film

APL-130277

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age.
• Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the "more than one affected relative" criterion)
• Clinically meaningful response to L-Dopa 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 at least 3 times per day, for at least 4 weeks before the initial Screening Visit (SV1). Adjunctive PD medication regimens must be maintained at a stable dose for at least 4 weeks prior to the initial Screening Visit (SV1) with the exception that MAO-B inhibitors must be maintained at a stable level for at least 8 weeks prior to the initial Screening Visit (SV1).
• No planned medication change(s) or surgical intervention anticipated during the course of study.
• Subject 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.
• Subject and/or caregiver must be trained in performing home dosing diary assessments of the motor state and must be able to recognize "ON" and "OFF" states.
• Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
• MMSE score \> 25.
• If female and of childbearing potential, must agree to be sexually abstinent or use one of the following highly effective methods of birth control:
• Hormonal contraceptives (eg, combined oral contraceptives, patch, vaginal ring, injectables, and implants);
• Intrauterine contraceptive system;
• Surgical sterilization or partner sterile (must have documented proof); AND
• One of the following effective methods of birth control:
• Male/female condom;

You may not qualify if:

• Atypical or secondary parkinsonism.
• Previous treatment with any of the following: a neurosurgical procedure for PD; continuous s.c. apomorphine infusion; Duodopa/Duopa; or APL-130277.
• Treatment with any form of s.c. apomorphine within 7 days prior to the second Screening Visit (SV2). 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).
• Female who is pregnant or lactating.
• Participation in a clinical trial within 30 days prior to the initial Screening Visit (SV1).
• Receipt of any investigational (ie, unapproved) medication within 30 days prior to the initial Screening Visit (SV1).
• Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents.
• Drug or alcohol dependency in the past 12 months.
• Subject has a history of malignancy within 5 years prior to the Screening visit, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
• 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.

Sponsors & Collaborators

• Sumitomo Pharma America, Inc.: lead

Study Sites (70)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

Muhammed Ali Parkinson and Movement Disorder Center/Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Movement Disorders Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

Location

The Parkinson's and Movement Disorder Institute

Fountain Valley, California, 92708, United States

Location

UC Irvine Health Gottschalk Medical Plaza

Irvine, California, 92697, United States

Location

Keck Medical Center at USC

Los Angeles, California, 90033, United States

Location

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Parkinsons Disease and Movement Disorders Center

Boca Raton, Florida, 33486, United States

Location

University of Miami, Miller School of Medicine

Miami, Florida, 33136, United States

Location

Parkinson's Disease Treatment Center of Southwest Florida

Port Charlotte, Florida, 33980, United States

Location

Suncoast Neuroscience Associates Inc.

St. Petersburg, Florida, 33713, United States

Location

USF Parkinson's Disease and Movement Disorder Center

Tampa, Florida, 33613, United States

Location

Emory University Department of Neurology

Atlanta, Georgia, 30329, United States

Location

GRU Movement Disorders

Augusta, Georgia, 30912, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NorthShore Neurological Institute B043D

Glenview, Illinois, 60026, United States

Location

Central DuPage Hospital - Neurodegenerative Clinic - Movement Disorders Center

Winfield, Illinois, 60190, United States

Location

University of Iowa Dept. of Neurology

Iowa City, Iowa, 52242, United States

Location

Kansas University Medical Center-Department of Neurology

Kansas City, Kansas, 66160, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Michigan State University - Dept. of Neurology

East Lansing, Michigan, 48824, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Henry Ford Hospital

West Bloomfield, Michigan, 48322, United States

Location

Park Nicolet Institute - Stuthers Parkinson's Center

Golden Valley, Minnesota, 55427, United States

Location

SUNY Downstate Medical Center, Department of Neurology

Brooklyn, New York, 11203, United States

Location

Bendheim Parkinson's and Movement Disorder Center (Mount Sinai Medical Center)

New York, New York, 10029, United States

Location

Columbia University Medical Center - Neurological Institute, Movement Disorders

New York, New York, 10032, United States

Location

Duke University - Movement Disorders Clinic

Durham, North Carolina, 27705, United States

Location

Raleigh Neurology Associates, P.A.

Raleigh, North Carolina, 27607, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

UT Gardner-McMaster Parkinson's Center

Toledo, Ohio, 43614, United States

Location

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

Jefferson University Hospital Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

East Texas Medical Center

Tyler, Texas, 75701, United States

Location

University of Virginia Adult Neurology

Charlottesville, Virginia, 322903, United States

Location

Sentara Neuroscience Institute

Virginia Beach, Virginia, 23456, United States

Location

Evergreen Health

Kirkland, Washington, 98034, United States

Location

Swedish Neuroscience Research

Seattle, Washington, 98122, United States

Location

Medical University Innsbruck Neurology Department

Innsbruck, A-6020, Austria

Location

Wilhelminenspital Department of Neurology

Vienna, 1160, Austria

Location

UHN Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Centre d'Investigation Clinique, CIC 1436, CHU Purpan

Toulouse, 31059, France

Location

St. Josef-Hospital, Klinikum der Ruhr-Universitaet-Bochum, Neurologische Klinik

Bochum, 44791, Germany

Location

Universitätsklinikum Ulm Neurologisches Studienzentrum im RKU

Ulm, 89081, Germany

Location

Ospedali Riuniti di Ancona

Ancona, 60126, Italy

Location

Centro Ricerche San Raffaele

Cassino, 03043, Italy

Location

Aging Research Center, Ce.S.I. University Foundation, Chieti-Pescara Behavioural Neurology & Movement Disorders Unit

Chieti, 66100, Italy

Location

IRCCS San Raffaele Pisana - Clinical Trial Center

Rome, 00163, Italy

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari General de Catalunya

Sant Cugat Del Vallés, 08195, Spain

Location

Kings College, The Maurice Wohl Neuroscience Institute

London, Greater London, United Kingdom

Location

Manchester University

Salford, Greater Manchester, M68HD, United Kingdom

Location

Newcastle University

Newcastle upon Tyne, Northumberland, NE4 5PL, United Kingdom

Location

Forth Valley Royal Hospital

Larbert, Stirlingshire, FK54WR, United Kingdom

Location

Fairfield General Hospital

Bury, BL9 7TD, United Kingdom

Location

Royal Devon & Exeter NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3EX, United Kingdom

Location

Imperial College Healthcare Trust NHS

London, W68RF, United Kingdom

Location

Plymouth University

Plymouth, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Apomorphine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Aporphines; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings

Results Point of Contact

• Title: CNS Medical Director
• Organization: Sumitomo Pharma America, Inc.

clinicaltrialdisclosure@sunovion.com

1-866-503-6351

Study Officials

• CNS Medical Director

  Sumitomo Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2015
• First Posted: September 7, 2015
• Study Start: August 31, 2015
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: November 22, 2023
• Results First Posted: November 22, 2023

Record last verified: 2023-10

Locations

DE (2); AU (2); IT (4); GB (10); ES (2); FR (1); CA (1); US (48)