Clinical trial NCT04379050: Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
Official title: An Open-label Extension of Study M15-741 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: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's Disease (PD)
ABBV-951
Levodopa/Carbidopa (LD/CD)
Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2020-05-07
Enrollment: 130
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741.

ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide.

Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily during the Primary Treatment Period and during the optional Extended Treatment Period.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Participants who have Parkinson's Disease and who have successfully completed the parent study M15-741.
* Participants willing and able to comply with procedures required in the protocol.

Exclusion Criteria:

- Participants, if judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AE)
timeFrame: Up To Week 96
measure: Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale
timeFrame: Up To Week 96
measure: Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale
timeFrame: Up To Week 96
measure: Change in Clinical Laboratory Test Data
timeFrame: Up To Week 96
measure: Change in Vital Signs Measurements
timeFrame: Up To Week 96
measure: Change From Baseline in Electrocardiograms (ECGs)
timeFrame: Up To Week 96
Secondary outcomes:
measure: Average Normalized Daily "Off" Time
timeFrame: Up To Week 96
measure: Average Normalized Daily "On" Time
timeFrame: Up To Week 96
measure: Parkinson's Disease (PD) Symptoms Measurement
timeFrame: Up To Week 96
measure: Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39)
timeFrame: Up To Week 96
measure: Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L)
timeFrame: Up To Week 96
measure: Cognitive Impairment Measurement
timeFrame: Up To Week 96
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 215597
state: Alabama
city: Sun City
country: United States
facility: Banner Sun Health Research Institute /ID# 215579
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Hospital /ID# 215625
state: Colorado
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412
state: Florida
city: Indianapolis
country: United States
facility: Indiana Clinical Research Cent /ID# 216490
state: Indiana
city: Kansas City
country: United States
facility: Univ Kansas Med Ctr /ID# 215624
state: Kansas
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 215472
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 216834
state: New Hampshire
city: Raleigh
country: United States
facility: M3 Wake Research Inc. /ID# 215596
state: North Carolina
city: Portland
country: United States
facility: Legacy Medical Group - Neurology /ID# 215536
state: Oregon
city: Houston
country: United States
facility: Baylor College of Medicine /ID# 215401
state: Texas
city: Round Rock
country: United States
facility: Central Texas Neurology Consul /ID# 217013
state: Texas
city: San Antonio
country: United States
facility: Univ Texas HSC San Antonio /ID# 215400
state: Texas
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center /ID# 215535
state: Washington
city: Spokane
country: United States
facility: Inland Northwest Research /ID# 215533
state: Washington
city: Concord
country: Australia
facility: Concord Repatriation General Hospital /ID# 215943
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 215941
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital /ID# 215940
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital /ID# 215942
state: Victoria
city: Nedlands
country: Australia
facility: Perron Institute /ID# 215944
state: Western Australia
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 215684
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 215686
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 215685
city: Calgary
country: Canada
facility: University of Calgary - Movement Disorders Clinic /ID# 215369
state: Alberta
city: Lévis
country: Canada
facility: Clinique Neuro Levis /ID# 215371
state: Quebec
city: Copenhagen NV
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital /ID# 215391
state: Hovedstaden
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital - Skejby /ID# 215392
state: Midtjylland
city: Odense
country: Denmark
facility: Odense University Hospital /ID# 215390
state: Syddanmark
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm /ID# 215405
state: Baden-Wuerttemberg
city: Haag i.OB
country: Germany
facility: curiositas ad sanum /ID# 215404
state: Bayern
city: Beelitz-Heilstaetten
country: Germany
facility: Kliniken Beelitz GmbH /ID# 215403
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova /ID# 215421
city: Asahikawa-shi
country: Japan
facility: National Hospital Organization Asahikawa Medical Center /ID# 218762
state: Hokkaido
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 217415
state: Osaka
city: Kodaira-shi
country: Japan
facility: National Center of Neurology and Psychiatry /ID# 218763
state: Tokyo
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis /ID# 215396
city: Sestroretsk
country: Russian Federation
facility: City Clinical Hospital #40 /ID# 218870
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 218869
state: Sankt-Peterburg
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña /ID# 215426
state: A Coruna
city: Elche
country: Spain
facility: Hospital General Universitario de Elche /ID# 215425
state: Alicante
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge /ID# 215427
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 215429
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 215431
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 215428
city: Lund
country: Sweden
facility: Skane University Hospital Lund /ID# 215385
state: Skane Lan
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset - Huddinge /ID# 215386
state: Stockholms Lan
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset /ID# 215387
state: Vastra Gotalands Lan
city: Plymouth
country: United Kingdom
facility: Derriford Hospital and the Royal Eye Infirmary /ID# 217390
state: Devon
city: Dundee
country: United Kingdom
facility: NHS Tayside /ID# 217389
state: Scotland
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust /ID# 217388
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: