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

NCT04379050 | Completed Phase 3 FDA Drug

• 2 other identifiers: M15-7372019-004235-23
• Study Type: interventional
• Target: 130
• Locations: 13 countries
• Sites: 51

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.

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's Disease (PD); ABBV-951; Levodopa/Carbidopa (LD/CD); Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP)

Outcome Measures

Primary Outcomes (6)

• Percentage of Participants With Adverse Events (AE)

  An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study drug or device as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Adverse Events of Special Interest (AESI) - polyneuropathy, weight loss, hallucinations/psychosis, and somnolence will be monitored throughout the study.

  Up To Week 96

• Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale

  The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an eight-point numeric scale used to assess irritation at the infusion site area (0 being "no evidence of irritation" and 7 being "strong reaction spreading beyond the test site").

  Up To Week 96

• Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale

  The Infusion Site Evaluation Scale will be used to assess infusion sites. Infusion Site Evaluation Scale is an A to G letter grade scale, used to assess irritation at the infusion site area (A being "no finding" to G being "Small petechial erosions and/or scabs").

  Up To Week 96

• Change in Clinical Laboratory Test Data

  Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study.

  Up To Week 96

• Change in Vital Signs Measurements

  Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.

  Up To Week 96

• Change From Baseline in Electrocardiograms (ECGs)

  Change from baseline in 12-lead ECGs on heart rate, RR interval, PR interval, QRS duration, and QT interval will be monitored throughout the study.

  Up To Week 96

Secondary Outcomes (6)

• Average Normalized Daily "Off" Time

  Up To Week 96

• Average Normalized Daily "On" Time

  Up To Week 96

• Parkinson's Disease (PD) Symptoms Measurement

  Up To Week 96

• Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39)

  Up To Week 96

• Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L)

  Up To Week 96

Study Arms (1)

ABBV-951

EXPERIMENTAL

Participants will receive ABBV-951 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for up to 96 weeks.

Drug: ABBV-951

Interventions

ABBV-951 DRUG

Solution for continuous subcutaneous infusion (CSCI).

Also known as: Foscarbidopa, Foslevodopa

ABBV-951

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (51)

University of Alabama at Birmingham - Main /ID# 215597

Birmingham, Alabama, 35233, United States

Location

Banner Sun Health Research Institute /ID# 215579

Sun City, Arizona, 85351, United States

Location

University of Colorado Hospital /ID# 215625

Aurora, Colorado, 80045, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412

Boca Raton, Florida, 33486, United States

Location

Indiana Clinical Research Cent /ID# 216490

Indianapolis, Indiana, 46202, United States

Location

Univ Kansas Med Ctr /ID# 215624

Kansas City, Kansas, 66160, United States

Location

Washington University-School of Medicine /ID# 215472

St Louis, Missouri, 63110, United States

Location

Dartmouth-Hitchcock Medical Center /ID# 216834

Lebanon, New Hampshire, 03756, United States

Location

M3 Wake Research - Raleigh /ID# 215596

Raleigh, North Carolina, 27612-8106, United States

Location

Legacy Medical Group - Neurology /ID# 215536

Portland, Oregon, 97232-2003, United States

Location

Baylor College of Medicine /ID# 215401

Houston, Texas, 77030, United States

Location

Central Texas Neurology Consul /ID# 217013

Round Rock, Texas, 78681, United States

Location

Univ Texas HSC San Antonio /ID# 215400

San Antonio, Texas, 78229-3901, United States

Location

Booth Gardner Parkinson's Care Center /ID# 215535

Kirkland, Washington, 98034-3029, United States

Location

Inland Northwest Research /ID# 215533

Spokane, Washington, 99202-1342, United States

Location

Concord Repatriation General Hospital /ID# 215943

Concord, New South Wales, 2139, Australia

Location

Westmead Hospital /ID# 215941

Westmead, New South Wales, 2145, Australia

Location

Duplicate_Royal Adelaide Hospital /ID# 215940

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital /ID# 215942

Melbourne, Victoria, 3004, Australia

Location

Perron Institute /ID# 215944

Nedlands, Western Australia, 6009, Australia

Location

Universitair Ziekenhuis Leuven /ID# 215684

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Duplicate_Algemeen Ziekenhuis Sint-Jan Brugge /ID# 215686

Bruges, West-Vlaanderen, 8000, Belgium

Location

Duplicate_Groupe Sante CHC - Clinique du MontLegia /ID# 215685

Liège, 4000, Belgium

Location

University of Calgary /ID# 215369

Calgary, Alberta, T2N 4Z6, Canada

Location

Clinique Neuro Levis /ID# 215371

Lévis, Quebec, G6W 0M5, Canada

Location

Bispebjerg and Frederiksberg Hospital /ID# 215391

Copenhagen NV, Capital Region, 2400, Denmark

Location

Aarhus Universitetshospital - Skejby /ID# 215392

Aarhus, Central Jutland, 8200, Denmark

Location

Odense University Hospital /ID# 215390

Odense, Region Syddanmark, 5000, Denmark

Location

Universitaetsklinikum Ulm /ID# 215405

Ulm, Baden-Wurttemberg, 89081, Germany

Location

curiositas ad sanum /ID# 215404

Haag i.OB, Bavaria, 83527, Germany

Location

Kliniken Beelitz GmbH /ID# 215403

Beelitz-Heilstätten, 14547, Germany

Location

IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422

Messina, 98124, Italy

Location

Azienda Ospedale-Universita Padova /ID# 215421

Padova, 35128, Italy

Location

National Hospital Organization Asahikawa Medical Center /ID# 218762

Asahikawa-shi, Hokkaido, 070-8644, Japan

Location

Duplicate_Osaka University Hospital /ID# 217415

Suita-shi, Osaka, 565-0871, Japan

Location

National Center of Neurology and Psychiatry /ID# 218763

Kodaira-shi, Tokyo, 187-8551, Japan

Location

St. Antonius Ziekenhuis, Locatie Utrecht /ID# 215396

Utrecht, 3543 AZ, Netherlands

Location

Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 218869

Saint Petersburg, Sankt-Peterburg, 197101, Russia

Location

City Clinical Hospital #40 /ID# 218870

Sestroretsk, Sankt-Peterburg, 197706, Russia

Location

Complejo Hospitalario Universitario A Coruña /ID# 215426

A Coruña, A Coruna, 15006, Spain

Location

Hospital General Universitario de Elche /ID# 215425

Elche, Alicante, 03203, Spain

Location

Hospital Universitari de Bellvitge /ID# 215427

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 215429

Barcelona, 08041, Spain

Location

Hospital Universitario Virgen de las Nieves /ID# 215431

Granada, 18014, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 215428

Seville, 41013, Spain

Location

Skane University Hospital Lund /ID# 215385

Lund, Skåne County, 224 84, Sweden

Location

Karolinska Universitetssjukhuset - Huddinge /ID# 215386

Huddinge, Stockholm County, 141 57, Sweden

Location

Sahlgrenska Universitetssjukhuset /ID# 215387

Gothenburg, Västra Götaland County, 413 46, Sweden

Location

Derriford Hospital and the Royal Eye Infirmary /ID# 217390

Plymouth, Devon, PL6 8DH, United Kingdom

Location

Kings College Hospital NHS Foundation Trust /ID# 217388

London, Greater London, SE5 9RS, United Kingdom

Location

NHS Tayside /ID# 217389

Dundee, Scotland, DD2 1UB, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

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: May 1, 2020
• First Posted: May 7, 2020
• Study Start: June 8, 2020
• Primary Completion: April 17, 2026
• Study Completion: April 17, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

IT (2); NL (1); DE (3); US (15); DK (3); CA (2); ES (6); SE (3); AU (5); JP (3); RU (2); GB (3); BE (3)