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
- Conditions
- Parkinson's Disease (PD)
- Interventions
- Drug: ABBV-951
- Registration Number
- NCT04379050
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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.
- Participants, if judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ABBV-951 ABBV-951 Participants will receive ABBV-951 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for up to 96 weeks.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events (AE) Up To Week 96 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.
Percentage Of Participants With Numeric Grade Equal To Or Higher Than 5 On The Infusion Site Evaluation Scale Up To Week 96 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").
Change in Vital Signs Measurements Up To Week 96 Number of participants with clinically significant change from baseline in vital signs will be reported throughout the study.
Change From Baseline in Electrocardiograms (ECGs) Up To Week 96 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.
Change in Clinical Laboratory Test Data Up To Week 96 Number of participants with clinically significant change from baseline in laboratory parameters (hematology, biochemistry, coagulation, and urinalysis) will be reported throughout the study.
Percentage Of Participants With Letter Grade Equal To Or Higher Than D On The Infusion Site Evaluation Scale Up To Week 96 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").
- Secondary Outcome Measures
Name Time Method Average Normalized Daily "On" Time Up To Week 96 Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary.
Parkinson's Disease (PD) Symptoms Measurement Up To Week 96 PD symptoms will be assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV.
The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39) Up To Week 96 Quality of life is assessed by the PD Questionnaire-39 items (PDQ-39). PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to participants with PD, and which may not be included in general health status questionnaires.
Each item is scored on a 5-point scale.Average Normalized Daily "Off" Time Up To Week 96 Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary.
Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L) Up To Week 96 Health-related quality of life is assessed by the EuroQol 5-dimensions questionnaire (EQ-5D-5L).
EQ-5D-5L is a standardized instrument that consists of 2 parts: the EQ-5D descriptive system and the EQ visual analogue-scale (EQVAS).Cognitive Impairment Measurement Up To Week 96 Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is used to assess orientation, attention, immediate and short term recall, language, and ability to follow simple verbal and written commands. The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 0 to 30, with higher scores indicating better function.
Trial Locations
- Locations (51)
Washington University-School of Medicine /ID# 215472
🇺🇸Saint Louis, Missouri, United States
Central Texas Neurology Consul /ID# 217013
🇺🇸Round Rock, Texas, United States
Booth Gardner Parkinson's Care Center /ID# 215535
🇺🇸Kirkland, Washington, United States
Concord Repatriation General Hospital /ID# 215943
🇦🇺Concord, New South Wales, Australia
The Alfred Hospital /ID# 215942
🇦🇺Melbourne, Victoria, Australia
Royal Adelaide Hospital /ID# 215940
🇦🇺Adelaide, South Australia, Australia
Universitaetsklinikum Ulm /ID# 215405
🇩🇪Ulm, Baden-Wuerttemberg, Germany
curiositas ad sanum /ID# 215404
🇩🇪Haag i.OB, Bayern, Germany
Kliniken Beelitz GmbH /ID# 215403
🇩🇪Beelitz-Heilstaetten, Germany
IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422
🇮🇹Messina, Italy
Azienda Ospedaliera di Padova /ID# 215421
🇮🇹Padova, Italy
National Hospital Organization Asahikawa Medical Center /ID# 218762
🇯🇵Asahikawa-shi, Hokkaido, Japan
Osaka University Hospital /ID# 217415
🇯🇵Suita-shi, Osaka, Japan
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 218869
🇷🇺St. Petersburg, Sankt-Peterburg, Russian Federation
Complejo Hospitalario Universitario A Coruña /ID# 215426
🇪🇸A Coruña, A Coruna, Spain
Hospital Universitari de Bellvitge /ID# 215427
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Skane University Hospital Lund /ID# 215385
🇸🇪Lund, Skane Lan, Sweden
Karolinska Universitetssjukhuset - Huddinge /ID# 215386
🇸🇪Huddinge, Stockholms Lan, Sweden
King's College Hospital NHS Foundation Trust /ID# 217388
🇬🇧London, United Kingdom
NHS Tayside /ID# 217389
🇬🇧Dundee, Scotland, United Kingdom
Baylor College of Medicine /ID# 215401
🇺🇸Houston, Texas, United States
Perron Institute /ID# 215944
🇦🇺Nedlands, Western Australia, Australia
Hospital General Universitario de Elche /ID# 215425
🇪🇸Elche, Alicante, Spain
Clinique Neuro Levis /ID# 215371
🇨🇦Lévis, Quebec, Canada
National Center of Neurology and Psychiatry /ID# 218763
🇯🇵Kodaira-shi, Tokyo, Japan
Universitair Ziekenhuis Leuven /ID# 215684
🇧🇪Leuven, Vlaams-Brabant, Belgium
St. Antonius Ziekenhuis /ID# 215396
🇳🇱Nieuwegein, Netherlands
AZ Sint-Jan Brugge /ID# 215686
🇧🇪Brugge, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 215685
🇧🇪Liege, Belgium
City Clinical Hospital #40 /ID# 218870
🇷🇺Sestroretsk, Sankt-Peterburg, Russian Federation
University of Calgary - Movement Disorders Clinic /ID# 215369
🇨🇦Calgary, Alberta, Canada
Derriford Hospital and the Royal Eye Infirmary /ID# 217390
🇬🇧Plymouth, Devon, United Kingdom
Bispebjerg and Frederiksberg Hospital /ID# 215391
🇩🇰Copenhagen NV, Hovedstaden, Denmark
Aarhus Universitetshospital - Skejby /ID# 215392
🇩🇰Aarhus, Midtjylland, Denmark
Odense University Hospital /ID# 215390
🇩🇰Odense, Syddanmark, Denmark
University of Alabama at Birmingham - Main /ID# 215597
🇺🇸Birmingham, Alabama, United States
Univ Texas HSC San Antonio /ID# 215400
🇺🇸San Antonio, Texas, United States
Sahlgrenska Universitetssjukhuset /ID# 215387
🇸🇪Göteborg, Vastra Gotalands Lan, Sweden
University of Colorado Hospital /ID# 215625
🇺🇸Aurora, Colorado, United States
Banner Sun Health Research Institute /ID# 215579
🇺🇸Sun City, Arizona, 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
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
Inland Northwest Research /ID# 215533
🇺🇸Spokane, Washington, United States
Westmead Hospital /ID# 215941
🇦🇺Westmead, New South Wales, Australia
Hospital Universitario Virgen de las Nieves /ID# 215431
🇪🇸Granada, Spain
Hospital Santa Creu i Sant Pau /ID# 215429
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocio /ID# 215428
🇪🇸Sevilla, Spain