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
NCT ID: NCT02542696
Last Updated: 2023-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
496 participants
INTERVENTIONAL
2015-08-31
2022-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
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
Used to treat up to 5 "OFF" episodes per day
Interventions
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APL-130277
Used to treat up to 5 "OFF" episodes per day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the "more than one affected relative" criterion)
3. Clinically meaningful response to L-Dopa as determined by the Investigator.
4. 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).
5. No planned medication change(s) or surgical intervention anticipated during the course of study.
6. 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.
7. 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.
8. Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
9. MMSE score \> 25.
10. 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;
* Cervical cap with spermicide;
* Diaphragm with spermicide;
* Contraceptive sponge.
11. Male subjects must be either surgically sterile, agree to be sexually inactive or use a double-barrier method of birth control (eg, condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration.
12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures.
13. Able to understand the consent form, and to provide written informed consent.
1. Completion of any of the following studies: CTH-201, CTH-203, CTH-300, or CTH 302; and, in the opinion of the Investigator, would benefit from continued treatment with APL 130277.
2. No major changes in concomitant PD medications since completion of any of the following studies: CTH-201, CTH-203, CTH-300, or CTH 302. Any change in PD medications since the previous study should be discussed with the Medical Monitor to determine subject eligibility in the current study.
3. 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;
* Cervical cap with spermicide;
* Diaphragm with spermicide;
* Contraceptive sponge.
4. Male subjects must be either surgically sterile, agree to be sexually inactive or use a double-barrier method of birth control (eg, condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration.
5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures.
6. Able to understand the consent form, and to provide written informed consent.
1. Completion of the CTH-301 study under protocol version 3.00, and in the opinion of the Investigator, would benefit from continued treatment with APL 130277.
2. 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;
* Cervical cap with spermicide;
* Diaphragm with spermicide;
* Contraceptive sponge.
3. Male subjects must be either surgically sterile, agree to be sexually inactive or use a double-barrier method of birth control (eg, condom and diaphragm with spermicide, condom with cervical cap and spermicide) from first study drug administration until 90 days after final drug administration.
4. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures.
5. Able to understand the consent form, and to provide written informed consent.
Exclusion Criteria
2. Previous treatment with any of the following: a neurosurgical procedure for PD; continuous s.c. apomorphine infusion; Duodopa/Duopa; or APL-130277.
3. 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.
4. Contraindications to APOKYN®, or hypersensitivity to apomorphine hydrochloride or any of the ingredients of APOKYN® (notably sodium metabisulfite).
5. Female who is pregnant or lactating.
6. Participation in a clinical trial within 30 days prior to the initial Screening Visit (SV1).
7. Receipt of any investigational (ie, unapproved) medication within 30 days prior to the initial Screening Visit (SV1).
8. Currently taking selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron, palonosetron, alosetron), dopamine antagonists (excluding quetiapine or clozapine) or dopamine depleting agents.
9. Drug or alcohol dependency in the past 12 months.
10. 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.
11. Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
12. 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.
13. History of clinically significant hallucinations during the past 6 months.
14. History of clinically significant impulse control disorder(s).
15. Dementia that precludes providing informed consent or would interfere with participation in the study.
16. Current suicidal ideation within one year prior to the second Screening Visit (SV2) as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C-SSRS or attempted suicide within the last 5 years.
17. Donation of blood or plasma in the 30 days prior to first dosing.
18. Presence of canker or mouth sores in the 30 days prior to the initial Screening Visit (SV1), or other clinically significant oral pathology in the opinion of the Investigator. The Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling a patient into the study.
1. Female who is pregnant or lactating.
2. Presence of any major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis (including clinically significant hallucinations during the past 6 months) or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
3. Presence of any clinically significant medical (including but not limited to CNS, cardiovascular, hepatic, pulmonary, metabolic, or renal events), surgical, or laboratory abnormality that would make study participation unsafe or make treatment compliance difficult. Clinical significance to be determined by the Investigator.
4. Receipt of any investigational (ie, unapproved) medication or participation in any clinical trial of an investigational product since completing a previous study using APL 130277.
5. Development of canker or mouth sores within 14 days of completing a previous study using APL-130277. For other clinically significant oral pathology, the Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling such a subject into the study. Clinical significance to be determined by the Investigator. The eligibility of subjects who have experienced AEs related to the oral cavity during the previous study using APL-130277, should be reviewed with the medical monitor and approval obtained.
6. Current suicidal ideation within one year of the screening visit, as evidenced by answering "yes" to Question 4 or 5 on the suicidal ideation portion of the C SSRS at Screening or attempted suicide within 5 years.
1. Female who is pregnant or lactating.
2. Presence of any major psychiatric disorder including, but not limited to, dementia, bipolar disorder, psychosis (including clinically significant hallucinations during the past 6 months) or any disorder that, in the opinion of the Investigator, requires ongoing treatment that would make study participation in unsafe or make treatment compliance difficult.
3. Presence of any clinically significant medical (including but not limited to CNS, cardiovascular, hepatic, pulmonary, metabolic, or renal events), surgical, or laboratory abnormality that would make study participation unsafe or make treatment compliance difficult. Clinical significance to be determined by the Investigator.
4. Receipt of any investigational (ie, unapproved) medication or participation in any clinical trial since completing the CTH 301 study.
5. Development of canker or mouth sores since completing the CTH 301 study. For other clinically significant oral pathology, the Investigator should follow-up with an appropriate specialist on any finding, if indicated, before enrolling such a patient into the study. Clinical significance to be determined by the Investigator.
6. Current suicidal ideation as evidenced by answering "yes" to Question 4 or 5 on the suicidal ideation portion of the C-SSRS at the Screening Visit Phase 2 (SVP2).
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 Center/Barrow Neurological Institute
Phoenix, Arizona, United States
Movement Disorders Center of Arizona
Scottsdale, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, 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
University of Colorado School of Medicine
Aurora, Colorado, 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
Suncoast Neuroscience Associates Inc.
St. Petersburg, Florida, United States
USF Parkinson's Disease and Movement Disorder Center
Tampa, Florida, United States
Emory University Department of Neurology
Atlanta, Georgia, United States
GRU Movement Disorders
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
NorthShore Neurological Institute B043D
Glenview, Illinois, United States
Central DuPage Hospital - Neurodegenerative Clinic - Movement Disorders Center
Winfield, Illinois, United States
University of Iowa Dept. of Neurology
Iowa City, Iowa, United States
Kansas University Medical Center-Department of Neurology
Kansas City, Kansas, United States
University of Kentucky
Lexington, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Michigan State University - Dept. of Neurology
East Lansing, Michigan, United States
QUEST Research Institute
Farmington Hills, Michigan, United States
Henry Ford Hospital
West Bloomfield, Michigan, United States
Park Nicolet Institute - Stuthers Parkinson's Center
Golden Valley, Minnesota, United States
SUNY Downstate Medical Center, Department of Neurology
Brooklyn, New York, United States
Bendheim Parkinson's and Movement Disorder Center (Mount Sinai Medical Center)
New York, New York, United States
Columbia University Medical Center - Neurological Institute, Movement Disorders
New York, New York, United States
Duke University - Movement Disorders Clinic
Durham, North Carolina, 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 Ohio State University Wexner Medical Center
Columbus, Ohio, United States
UT Gardner-McMaster Parkinson's Center
Toledo, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Jefferson University Hospital Philadelphia
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
East Texas Medical Center
Tyler, Texas, United States
University of Virginia Adult Neurology
Charlottesville, Virginia, United States
Sentara Neuroscience Institute
Virginia Beach, Virginia, United States
Evergreen Health
Kirkland, Washington, United States
Swedish Neuroscience Research
Seattle, Washington, United States
Medical University Innsbruck Neurology Department
Innsbruck, , Austria
Wilhelminenspital Department of Neurology
Vienna, , Austria
UHN Toronto Western Hospital
Toronto, Ontario, Canada
Centre d'Investigation Clinique, CIC 1436, CHU Purpan
Toulouse, , France
St. Josef-Hospital, Klinikum der Ruhr-Universitaet-Bochum, Neurologische Klinik
Bochum, , Germany
Universitätsklinikum Ulm Neurologisches Studienzentrum im RKU
Ulm, , Germany
Ospedali Riuniti di Ancona
Ancona, , Italy
Centro Ricerche San Raffaele
Cassino, , Italy
Aging Research Center, Ce.S.I. University Foundation, Chieti-Pescara Behavioural Neurology & Movement Disorders Unit
Chieti, , Italy
IRCCS San Raffaele Pisana - Clinical Trial Center
Rome, , Italy
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitari General de Catalunya
Sant Cugat Del Vallés, , Spain
Kings College, The Maurice Wohl Neuroscience Institute
London, Greater London, United Kingdom
Manchester University
Salford, Greater Manchester, United Kingdom
Newcastle University
Newcastle upon Tyne, Northumberland, United Kingdom
Forth Valley Royal Hospital
Larbert, Stirlingshire, United Kingdom
Fairfield General Hospital
Bury, , United Kingdom
Royal Devon & Exeter NHS Foundation Trust
Exeter, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Imperial College Healthcare Trust NHS
London, , United Kingdom
Plymouth University
Plymouth, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000637-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTH-301
Identifier Type: -
Identifier Source: org_study_id