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

NCT ID: NCT04379050

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2026-04-30

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABBV-951

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

Group Type: EXPERIMENTAL

ABBV-951

Intervention Type: DRUG

Solution for continuous subcutaneous infusion (CSCI).

Interventions

ABBV-951

Solution for continuous subcutaneous infusion (CSCI).

Intervention Type: DRUG

Other Intervention Names

Foscarbidopa; Foslevodopa

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

University of Alabama at Birmingham - Main /ID# 215597

Birmingham, Alabama, United States

Banner Sun Health Research Institute /ID# 215579

Sun City, Arizona, United States

University of Colorado Hospital /ID# 215625

Aurora, Colorado, United States

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

Boca Raton, Florida, United States

Indiana Clinical Research Cent /ID# 216490

Indianapolis, Indiana, United States

Univ Kansas Med Ctr /ID# 215624

Kansas City, Kansas, United States

Washington University-School of Medicine /ID# 215472

St Louis, Missouri, United States

Dartmouth-Hitchcock Medical Center /ID# 216834

Lebanon, New Hampshire, United States

M3 Wake Research Inc. /ID# 215596

Raleigh, North Carolina, United States

Legacy Medical Group - Neurology /ID# 215536

Portland, Oregon, United States

Baylor College of Medicine /ID# 215401

Houston, Texas, United States

Central Texas Neurology Consul /ID# 217013

Round Rock, Texas, United States

Univ Texas HSC San Antonio /ID# 215400

San Antonio, Texas, United States

Booth Gardner Parkinson's Care Center /ID# 215535

Kirkland, Washington, United States

Inland Northwest Research /ID# 215533

Spokane, Washington, United States

Concord Repatriation General Hospital /ID# 215943

Concord, New South Wales, Australia

Westmead Hospital /ID# 215941

Westmead, New South Wales, Australia

Duplicate_Royal Adelaide Hospital /ID# 215940

Adelaide, South Australia, Australia

The Alfred Hospital /ID# 215942

Melbourne, Victoria, Australia

Perron Institute /ID# 215944

Nedlands, Western Australia, Australia

Universitair Ziekenhuis Leuven /ID# 215684

Leuven, Vlaams-Brabant, Belgium

Duplicate_Algemeen Ziekenhuis Sint-Jan Brugge /ID# 215686

Bruges, West-Vlaanderen, Belgium

Duplicate_Groupe Sante CHC - Clinique du MontLegia /ID# 215685

Liège, , Belgium

University of Calgary /ID# 215369

Calgary, Alberta, Canada

Clinique Neuro Levis /ID# 215371

Lévis, Quebec, Canada

Bispebjerg and Frederiksberg Hospital /ID# 215391

Copenhagen NV, Capital Region, Denmark

Aarhus Universitetshospital - Skejby /ID# 215392

Aarhus, Central Jutland, Denmark

Odense University Hospital /ID# 215390

Odense, Region Syddanmark, Denmark

Universitaetsklinikum Ulm /ID# 215405

Ulm, Baden-Wurttemberg, Germany

curiositas ad sanum /ID# 215404

Haag i.OB, Bavaria, Germany

Kliniken Beelitz GmbH /ID# 215403

Beelitz-Heilstätten, , Germany

IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422

Messina, , Italy

Azienda Ospedale-Universita Padova /ID# 215421

Padua, , Italy

National Hospital Organization Asahikawa Medical Center /ID# 218762

Asahikawa-shi, Hokkaido, Japan

Duplicate_Osaka University Hospital /ID# 217415

Suita-shi, Osaka, Japan

National Center of Neurology and Psychiatry /ID# 218763

Kodaira-shi, Tokyo, Japan

St. Antonius Ziekenhuis /ID# 215396

Nieuwegein, Utrecht, Netherlands

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

Saint Petersburg, Sankt-Peterburg, Russia

City Clinical Hospital #40 /ID# 218870

Sestroretsk, Sankt-Peterburg, Russia

Complejo Hospitalario Universitario A Coruña /ID# 215426

A Coruña, A Coruna, Spain

Hospital General Universitario de Elche /ID# 215425

Elche, Alicante, Spain

Hospital Universitari de Bellvitge /ID# 215427

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Santa Creu i Sant Pau /ID# 215429

Barcelona, , Spain

Hospital Universitario Virgen de las Nieves /ID# 215431

Granada, , Spain

Hospital Universitario Virgen del Rocio /ID# 215428

Seville, , Spain

Skane University Hospital Lund /ID# 215385

Lund, Skåne County, Sweden

Karolinska Universitetssjukhuset - Huddinge /ID# 215386

Huddinge, Stockholm County, Sweden

Sahlgrenska Universitetssjukhuset /ID# 215387

Gothenburg, Västra Götaland County, Sweden

Derriford Hospital and the Royal Eye Infirmary /ID# 217390

Plymouth, Devon, United Kingdom

NHS Tayside /ID# 217389

Dundee, Scotland, United Kingdom

King's College Hospital NHS Foundation Trust /ID# 217388

London, , United Kingdom

Countries

United States; Australia; Belgium; Canada; Denmark; Germany; Italy; Japan; Netherlands; Russia; Spain; Sweden; United Kingdom

Other Identifiers

2019-004235-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-737

Identifier Type: -

Identifier Source: org_study_id