Clinical trial NCT03781167: A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
Official title: A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's Disease (PD)
ABBV-951
Levodopa/Carbidopa
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-12-19
Enrollment: 244
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).

This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.


Eligibility criteria: Inclusion Criteria:

* Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
* Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion Criteria:

* Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
* Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
measure: Number of Participants With Adverse Events of Special Interest
timeFrame: From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
measure: Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale
timeFrame: Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52
measure: Hematocrit (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Hemoglobin (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Neutrophils (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Lymphocytes (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Monocytes (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Absolute Platelet Count (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Creatinine (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Sodium (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Potassium (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Calcium (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Albumin (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Glucose (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Magnesium (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, and 52
measure: Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, and 52
measure: Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, and 52
measure: pH (Urinalysis): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Specific Gravity (Urinalysis): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 26, 39, and 52
measure: Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
measure: Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
measure: Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
timeFrame: Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
measure: Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
timeFrame: Baseline, Day 1 (postdose), Weeks 6 and 52
measure: Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
timeFrame: Baseline, Day 1 (postdose), Weeks 6 and 52
measure: Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
timeFrame: Baseline, Day 1 (postdose), Weeks 6 and 52
measure: Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
timeFrame: Baseline, Day 1 (postdose), Weeks 6 and 52
measure: Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
timeFrame: Baseline, Day 1 (postdose), Weeks 6 and 52
measure: Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
timeFrame: Baseline, Day 1 (postdose), Weeks 6 and 52
measure: Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
timeFrame: Baseline, Day 1 (postdose), Weeks 6 and 52
Secondary outcomes:
measure: Average Daily Normalized "Off" Time: Change From Baseline to End of Study
timeFrame: Baseline, Weeks 1, 6, 13, 26, 39, and 52
measure: Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
timeFrame: Baseline, Weeks 1, 6, 13, 26, 39, and 52
measure: Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
timeFrame: Baseline, Weeks 1, 6, 13, 26, 39, and 52
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
timeFrame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
timeFrame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
timeFrame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
timeFrame: Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
measure: Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 13, 26, 39, and 52
measure: Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 13, 26, 39, and 52
measure: The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
timeFrame: Baseline, Weeks 6, 13, 26, 39, and 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 207996
state: Alabama
city: Sun City
country: United States
facility: Banner Sun Health Res Inst /ID# 208811
state: Arizona
city: Fountain Valley
country: United States
facility: The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital /ID# 207968
state: Colorado
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 208812
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Clinical Research Cent /ID# 207952
state: Indiana
city: Kansas City
country: United States
facility: Univ Kansas Med Ctr /ID# 208963
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center /ID# 207603
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital /ID# 207993
state: Massachusetts
city: Saint Paul
country: United States
facility: Health Partners /ID# 207950
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri /ID# 209043
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 207525
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 207972
state: New Hampshire
city: Raleigh
country: United States
facility: Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 209784
state: North Carolina
city: Portland
country: United States
facility: Legacy Medical Group - Neurology /ID# 208031
state: Oregon
city: Greenville
country: United States
facility: Prisma Health Cancer Institute-Faris Road /ID# 207650
state: South Carolina
city: Dallas
country: United States
facility: Neurology Consultants of Dallas - LBJ Fwy /ID# 207619
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine /ID# 207620
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consul /ID# 216918
state: Texas
city: San Antonio
country: United States
facility: Univ Texas HSC San Antonio /ID# 208958
state: Texas
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center /ID# 208026
state: Washington
city: Spokane
country: United States
facility: Inland Northwest Research /ID# 208122
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin /ID# 207999
state: Wisconsin
city: Concord
country: Australia
facility: Concord Repatriation General Hospital /ID# 207628
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 207633
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 207634
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Health /ID# 207632
state: Victoria
city: Nedlands
country: Australia
facility: Perron Institute /ID# 207627
state: Western Australia
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 209058
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 208178
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 208177
city: Calgary
country: Canada
facility: University of Calgary - Movement Disorders Clinic /ID# 207342
state: Alberta
city: Quebec City
country: Canada
facility: Centre de Recherche St-Louis /ID# 207344
state: Quebec
city: Copenhagen NV
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital /ID# 207669
state: Hovedstaden
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital /ID# 207668
state: Midtjylland
city: Odense C
country: Denmark
facility: Odense University Hospital /ID# 207871
state: Syddanmark
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm /ID# 208602
state: Baden-Wuerttemberg
city: Beelitz-Heilstaetten
country: Germany
facility: Kliniken Beelitz GmbH /ID# 208600
city: Haag
country: Germany
facility: InnKlinikum Haag /ID# 208601
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo /ID# 207975
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 207955
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova /ID# 208077
city: Asahikawa-shi
country: Japan
facility: National Hospital Organization Asahikawa Medical Center /ID# 210914
state: Hokkaido
city: Kyoto-shi
country: Japan
facility: National Hospital Organization Utano National Hospital /ID# 210912
state: Kyoto
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 210913
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 210915
state: Tokyo
city: Kodaira-shi
country: Japan
facility: National Center of Neurology and Psychiatry /ID# 210911
state: Tokyo
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum /ID# 208168
state: Zuid-Holland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis /ID# 208529
city: Sestroretsk
country: Russian Federation
facility: City Clinical Hospital #40 /ID# 216301
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 216303
state: Sankt-Peterburg
city: Elche
country: Spain
facility: Hospital General Universitario de Elche /ID# 209777
state: Alicante
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge /ID# 209539
state: Barcelona
city: A Coruna
country: Spain
facility: Hospital Universitario A Coruna - CHUAC /ID# 212147
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 208240
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 208242
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 208241
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 208239
city: Lund
country: Sweden
facility: Skane University Hospital Lund /ID# 207811
state: Skane Lan
city: Stockholm
country: Sweden
facility: Centrum for neurologi /ID# 207716
state: Stockholms Lan
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital /ID# 207718
state: Vastra Gotalands Lan
city: Dundee
country: United Kingdom
facility: NHS Tayside /ID# 209242
state: Scotland
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 208413
city: Plymouth
country: United Kingdom
facility: University Hospital Plymouth NHS Trust /ID# 208447
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: