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
- Interventions
- Drug: APL-130277
- Registration Number
- NCT02542696
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 496
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description APL-130277 APL-130277 APL-130277 sublingual thin film (10 mg, 15 mg, 20 mg, 25 mg, 30 mg and 35 mg)
- Primary Outcome Measures
Name Time Method Evaluation of Safety and Tolerability Data Collected, Based on Number of Participants With Adverse Events in the LTS Phase up to approximately 3 years Number of Participants (%) with Adverse Events in the LTS Phase
- Secondary Outcome Measures
Name Time Method 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
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 Percentage of Subjects With a Subject-rated Full "ON" Response Within 30 Minutes at Week 48 Visit (LTS V6) of the LTS Phase. Week 48 Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. Week 24, 15 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. Week 24, 30 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
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 Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. Week 24, 60 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 90 Minutes After Dosing at Week 24 Visit (LTS V4) of the LTS Phase. Week 24, 90 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase. Week 36, 15 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase. Week 36, 30 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase. Week 36, 60 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 90 Minutes After Dosing at Week 36 Visit (LTS V5) of the LTS Phase. Week 36, 90 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 15 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase. Week 48, 15 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 30 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase. Week 48, 30 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 60 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase. Week 48, 60 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Mean Change From Pre-dose in MDS-UPDRS Part III Motor Examination (MDS UPDRS MOTOR) Score at 90 Minutes After Dosing at Week 48 Visit (LTS V6) of the LTS Phase. Week 48, 90 mins after dosing The summary score used here is Part III motor examination score. Higher MDS-UPDRS scores reflect worse motor function. MDS-UPDRS III is a total of 18 questions with 33 individual items, each item ranges from 0-4 (0=normal, 1=slight, 2=mild, 3= moderate, and 4=severe). The MDS-UPDRS III motor score is the summation of all these 33 individual item scores, and hence ranges from 0-132. Score drops over time imply improvement in motor function (higher values represent a worse outcome).
Trial Locations
- Locations (70)
Keck Medical Center at USC
🇺🇸Los Angeles, California, United States
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
UC Irvine Health Gottschalk Medical Plaza
🇺🇸Irvine, California, United States
Michigan State University - Dept. of Neurology
🇺🇸East Lansing, Michigan, United States
UT Gardner-McMaster Parkinson's Center
🇺🇸Toledo, Ohio, United States
East Texas Medical Center
🇺🇸Tyler, Texas, United States
Imperial College Healthcare Trust NHS
🇬🇧London, United Kingdom
Bendheim Parkinson's and Movement Disorder Center (Mount Sinai Medical Center)
🇺🇸New York, New York, United States
SUNY Downstate Medical Center, Department of Neurology
🇺🇸Brooklyn, New York, United States
Hospital Universitari General de Catalunya
🇪🇸Sant Cugat del Vallés, Spain
Central DuPage Hospital - Neurodegenerative Clinic - Movement Disorders Center
🇺🇸Winfield, Illinois, United States
Parkinson's Disease Treatment Center of Southwest Florida
🇺🇸Port Charlotte, Florida, United States
Universitätsklinikum Ulm Neurologisches Studienzentrum im RKU
🇩🇪Ulm, Germany
Columbia University Medical Center - Neurological Institute, Movement Disorders
🇺🇸New York, New York, United States
Raleigh Neurology Associates, P.A.
🇺🇸Raleigh, North Carolina, United States
Jefferson University Hospital Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Kings College, The Maurice Wohl Neuroscience Institute
🇬🇧London, Greater London, United Kingdom
GRU Movement Disorders
🇺🇸Augusta, Georgia, United States
NorthShore Neurological Institute B043D
🇺🇸Glenview, Illinois, United States
St. Josef-Hospital, Klinikum der Ruhr-Universitaet-Bochum, Neurologische Klinik
🇩🇪Bochum, Germany
QUEST Research Institute
🇺🇸Farmington Hills, Michigan, United States
UHN Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Sentara Neuroscience Institute
🇺🇸Virginia Beach, Virginia, United States
University of Iowa Dept. of Neurology
🇺🇸Iowa City, Iowa, United States
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Henry Ford Hospital
🇺🇸West Bloomfield, Michigan, United States
Centro Ricerche San Raffaele
🇮🇹Cassino, Italy
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Plymouth University
🇬🇧Plymouth, United Kingdom
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Houston Methodist Neurological Institute
🇺🇸Houston, Texas, United States
University of Miami, Miller School of Medicine
🇺🇸Miami, Florida, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Swedish Neuroscience Research
🇺🇸Seattle, Washington, United States
Muhammed Ali Parkinson and Movement Disorder Center/Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Duke University - Movement Disorders Clinic
🇺🇸Durham, North Carolina, United States
Wilhelminenspital Department of Neurology
🇦🇹Wien, Austria
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Medical University Innsbruck Neurology Department
🇦🇹Innsbruck, Austria
Newcastle University
🇬🇧Newcastle-upon-Tyne, Northumberland, United Kingdom
Royal Devon & Exeter NHS Foundation Trust
🇬🇧Exeter, United Kingdom
Ospedali Riuniti di Ancona
🇮🇹Ancona, Italy
IRCCS San Raffaele Pisana - Clinical Trial Center
🇮🇹Rome, Italy
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Fairfield General Hospital
🇬🇧Bury, United Kingdom
The Parkinson's and Movement Disorder Institute
🇺🇸Fountain Valley, California, United States
Movement Disorders Center of Arizona
🇺🇸Scottsdale, Arizona, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Parkinsons Disease and Movement Disorders Center
🇺🇸Boca Raton, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Emory University Department of Neurology
🇺🇸Atlanta, Georgia, United States
Suncoast Neuroscience Associates Inc.
🇺🇸Saint Petersburg, Florida, United States
Kansas University Medical Center-Department of Neurology
🇺🇸Kansas City, Kansas, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Park Nicolet Institute - Stuthers Parkinson's Center
🇺🇸Golden Valley, Minnesota, United States
The Movement Disorder Clinic of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
University of Virginia Adult Neurology
🇺🇸Charlottesville, Virginia, United States
Evergreen Health
🇺🇸Kirkland, Washington, United States
Centre d'Investigation Clinique, CIC 1436, CHU Purpan
🇫🇷Toulouse, France
Aging Research Center, Ce.S.I. University Foundation, Chieti-Pescara Behavioural Neurology & Movement Disorders Unit
🇮🇹Chieti, Italy
Forth Valley Royal Hospital
🇬🇧Larbert, Stirlingshire, United Kingdom
Manchester University
🇬🇧Salford, Greater Manchester, United Kingdom
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
USF Parkinson's Disease and Movement Disorder Center
🇺🇸Tampa, Florida, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States