Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease

Parkinson's Disease (PD) Clinical Trial

Official title:

An Open-Label Extension of Studies M15-736 and M20-339 to Evaluate the Safety and Tolerability of 24-Hour Daily Exposure of ABBV-951 in Subjects With Advanced Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04750226
• Other study ID #: M20-098
• Secondary ID: 2019-004204-35
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 18, 2021
• Est. completion date: May 16, 2025

Study information

• Verified date: September 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given as an infusion under the skin for the treatment of Parkinson's Disease. Adult participants with advanced PD and who have completed M15-736 or M20-339 study will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 60 sites in the United States and Australia. Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of ABBV-951 for 96 weeks 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 visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical and remote telephone assessments, blood tests, checking for side effects, and completing questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: May 16, 2025
• Est. primary completion date: May 16, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Completion of the parent study, Study M15-736 or Study M20-339.

Exclusion Criteria:

• Participant considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease (PD)

Intervention

Drug:
• ABBV-951
Solution for continuous subcutaneous infusion (CSCI).

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital /ID# 218417	Adelaide	South Australia
Australia	Liverpool Hospital /ID# 221693	Liverpool	New South Wales
Australia	The Royal Melbourne Hospital /ID# 218419	Parkville	Victoria
Australia	Gold coast University Hospital /ID# 221694	SouthPort	Queensland
Australia	Westmead Hospital /ID# 218418	Westmead	New South Wales
United States	University of Colorado Hospital /ID# 218486	Aurora	Colorado
United States	St. David's Healthcare Partnership, L.P., LLP /ID# 248148	Austin	Texas
United States	University of Alabama at Birmingham - Main /ID# 217814	Birmingham	Alabama
United States	Alpine Clinical Research Center /ID# 218461	Boulder	Colorado
United States	St Elizabeth's Medical Center - Brighton /ID# 223082	Brighton	Massachusetts
United States	Rush University Medical Center /ID# 217807	Chicago	Illinois
United States	University of Chicago Medical /ID# 218611	Chicago	Illinois
United States	Houston Pulmonary Sleep and Allergy Associates /ID# 218473	Cypress	Texas
United States	Denver Neurological Research, LLC /ID# 217811	Denver	Colorado
United States	CenExel Rocky Mountain Clinical Research, LLC /ID# 217731	Englewood	Colorado
United States	KCA Neurology - Franklin /ID# 222811	Franklin	Tennessee
United States	Neuro Pain Medical Center /ID# 217720	Fresno	California
United States	Texas Movement Disorder Specialists /ID# 218610	Georgetown	Texas
United States	Prisma Health-Upstate /ID# 217803	Greenville	South Carolina
United States	Baylor College of Medicine - Baylor Medical Center /ID# 217728	Houston	Texas
United States	St. Luke's Hosp. of Kansas City /ID# 218604	Kansas City	Missouri
United States	Northwell Health /ID# 218600	Lake Success	New York
United States	Global Neurosciences Institute /ID# 218472	Lawrenceville	New Jersey
United States	Loma Linda University Medical /ID# 217724	Loma Linda	California
United States	University of California, Los Angeles /ID# 218460	Los Angeles	California
United States	Visionary Investigators Network - Miami /ID# 217726	Miami	Florida
United States	Medical College of Wisconsin /ID# 217721	Milwaukee	Wisconsin
United States	University of South Alabama /ID# 218467	Mobile	Alabama
United States	Vanderbilt University Medical Center /ID# 217722	Nashville	Tennessee
United States	The Orthopedic Foundation /ID# 218608	New Albany	Ohio
United States	Renstar Medical Research /ID# 217837	Ocala	Florida
United States	Neurology Associates Ormond Beach /ID# 217800	Ormond Beach	Florida
United States	SC3 Research Group - Pasadena /ID# 223018	Pasadena	California
United States	Thomas Jefferson University Hospital /ID# 218594	Philadelphia	Pennsylvania
United States	University of Pennsylvania /ID# 218605	Philadelphia	Pennsylvania
United States	Muhammad Ali Parkinson Center /ID# 218609	Phoenix	Arizona
United States	Xenoscience, Inc /ID# 222515	Phoenix	Arizona
United States	Parkinson's Disease Treatment Center of Southwest Florida /ID# 222679	Port Charlotte	Florida
United States	Coastal Neurology /ID# 222893	Port Royal	South Carolina
United States	Legacy Medical Group - Neurology /ID# 217804	Portland	Oregon
United States	M3 Wake Research Inc. /ID# 218482	Raleigh	North Carolina
United States	Neurological Associates - Forest Ave /ID# 218458	Richmond	Virginia
United States	Washington University-School of Medicine /ID# 217723	Saint Louis	Missouri
United States	University of Utah Health Care /ID# 218597	Salt Lake City	Utah
United States	University of California, San /ID# 218595	San Diego	California
United States	Movement Disorders Center of Arizona /ID# 218471	Scottsdale	Arizona
United States	Inland Northwest Research /ID# 222520	Spokane	Washington
United States	University of South Florida /ID# 218481	Tampa	Florida
United States	The Movement Disorder Clinic of Oklahoma /ID# 218580	Tulsa	Oklahoma
United States	Georgetown University Hospital /ID# 218599	Washington	District of Columbia
United States	Cedars-Sinai Medical Center-West Hollywood /ID# 218607	West Hollywood	California
United States	Premiere Research Institute - Palm Beach /ID# 218743	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Adverse Event (AEs)	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 this treatment. An 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above.	Up to Week 96
Primary	Percentage of Participants with AEs of Special Interest (AESIs)	AESIs are defined as AEs from "special situations," such as accidental or intentional overdose, medication error, occupational or accidental exposure, off-label use, drug abuse, drug misuse, or drug withdrawal, all which must be reported whether associated with an AE or not.	Up to Week 96
Primary	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
Primary	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
Primary	Change From Baseline in Suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	C-SSRS is a systematically administered instrument designed to assess suicidal behavior and ideation, track and assess all suicidal events, and assess the lethality of attempts. Any participant who has suicidal behavior or suicidal ideation with plan since the last C-SSRS completed, will be evaluated immediately by the investigator.	Up To Week 96
Primary	Change From Baseline in Impulsive-Compulsive Disorders and related behaviors as assessed in Parkinson's Disease- Rating Scale (QUIP-RS)	The QUIP-RS is a brief, self-completed or rater-administered rating scale to assess the severity of symptoms of impulse control disorders (ICDs) and related behaviors reported to occur in PD. The QUIP-RS uses a 5-point Likert scale that requires individuals to rate the severity of each symptom based on its frequency.	Up To Week 96
Primary	Change From Baseline in Cognitive Impairment as Assessed by the Mini-Mental State Examination (MMSE)	Cognitive impairment is assessed by the Mini-Mental State Examination (MMSE). MMSE is a brief 30-point questionnaire, administered by a trained rater, that provides a quantitative measure of cognitive status in adults and is used widely to screen for cognitive impairment and to estimate the severity of cognitive impairment at a given point in time, to follow the course of changes in a patient over time, and to document response to treatment.	Up To Week 96
Primary	Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed.	Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed..	Up to Week 96
Primary	Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements like Systolic and Diastolic Blood Pressure will be Assessed	Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.	Up to Week 96
Primary	Change From Baseline in Electrocardiograms (ECGs)	12-lead resting ECGs will be recorded. Parameters include RR interval, PR interval, QT interval, and QRS duration.	Up to Week 96
Secondary	Change From Baseline in Average Normalized "On" Time as Assessed by the Parkinson's Disease (PD) Diary	Change in "On" time without dyskinesia or with non-troublesome dyskinesia as assessed by the PD diary.	Up To Week 96
Secondary	Change From Baseline in Average Daily Normalized "Off" Time as Assessed by the PD Diary	Change in average daily normalized "Off" Time (Hours) is assessed based on PD Diary.	Up To Week 96
Secondary	Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I	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.	Up To Week 96
Secondary	Change From Baseline in Motor Experiences of Daily Living	Motor experiences of daily living is assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. 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.	Up To Week 96
Secondary	Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III	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.	Up To Week 96
Secondary	Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Part 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.	Up To Week 96
Secondary	Change From Baseline in PD Symptoms as Assessed by the MDS-UPDRS Tool Parts I-III	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.	Up To Week 96
Secondary	Change From Baseline in Sleep Symptoms	Sleep symptoms are assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2). The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep.	Up To Week 96
Secondary	Change From Baseline in Quality Of Life as Assessed by the PD Questionnaire-39 item (PDQ-39)	Quality of life is assessed by the PD Questionnaire-39 item (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.	Up To Week 96
Secondary	Change From Baseline in Health-related Quality of Life as Assessed by EQ-5D-5L	Health-related quality of life is assessed by 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 (EQ-VAS).	Up To Week 96
Secondary	Percentage Of Participants With Early Morning "Off" Assessed by the PD Diary as Percentage of Participants with early morning "Off" Upon Waking Up	Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.	Up To Week 96