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

Parkinson's Disease (PD) Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04379050
• Other study ID #: M15-737
• Secondary ID: 2019-004235-23
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 8, 2020
• Est. completion date: June 19, 2025

Study information

• Verified date: November 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: June 19, 2025
• Est. primary completion date: June 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

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# 215940	Adelaide	South Australia
Australia	Concord Repatriation General Hospital /ID# 215943	Concord	New South Wales
Australia	Alfred Health /ID# 215942	Melbourne	Victoria
Australia	Perron Institute /ID# 215944	Nedlands	Western Australia
Australia	Westmead Hospital /ID# 215941	Westmead	New South Wales
Belgium	AZ Sint-Jan Brugge /ID# 215686	Brugge
Belgium	Universitair Ziekenhuis Leuven /ID# 215684	Leuven	Vlaams-Brabant
Belgium	Groupe Sante CHC - Clinique du MontLegia /ID# 215685	Liege
Canada	University of Calgary - Movement Disorders Clinic /ID# 215369	Calgary	Alberta
Canada	Clinique Neuro Levis /ID# 215371	Lévis	Quebec
Denmark	Aarhus University Hospital /ID# 215392	Aarhus N	Midtjylland
Denmark	Bispebjerg and Frederiksberg Hospital /ID# 215391	Copenhagen NV	Hovedstaden
Denmark	Odense University Hospital /ID# 215390	Odense C	Syddanmark
Germany	Kliniken Beelitz GmbH /ID# 215403	Beelitz-Heilstaetten
Germany	InnKlinikum Haag /ID# 215404	Haag
Germany	Universitaetsklinikum Ulm /ID# 215405	Ulm	Baden-Wuerttemberg
Italy	IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422	Messina
Italy	Azienda Ospedaliera di Padova /ID# 215421	Padova
Japan	National Hospital Organization Asahikawa Medical Center /ID# 218762	Asahikawa-shi	Hokkaido
Japan	National Center of Neurology and Psychiatry /ID# 218763	Kodaira-shi	Tokyo
Japan	Osaka University Hospital /ID# 217415	Suita-shi	Osaka
Netherlands	St. Antonius Ziekenhuis /ID# 215396	Nieuwegein
Russian Federation	City Clinical Hospital #40 /ID# 218870	Sestroretsk	Sankt-Peterburg
Russian Federation	Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 218869	St. Petersburg	Sankt-Peterburg
Spain	Hospital Universitario A Coruna - CHUAC /ID# 215426	A Coruna
Spain	Hospital Santa Creu i Sant Pau /ID# 215429	Barcelona
Spain	Hospital General Universitario de Elche /ID# 215425	Elche	Alicante
Spain	Hospital Universitario Virgen de las Nieves /ID# 215431	Granada
Spain	Hospital Universitario de Bellvitge /ID# 215427	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital Universitario Virgen del Rocio /ID# 215428	Sevilla
Sweden	Sahlgrenska University Hospital /ID# 215387	Gothenburg	Vastra Gotalands Lan
Sweden	Skane University Hospital Lund /ID# 215385	Lund	Skane Lan
Sweden	Karolinska University Hospital /ID# 215386	Stockholm
United Kingdom	NHS Tayside /ID# 217389	Dundee	Scotland
United Kingdom	King's College Hospital NHS Foundation Trust /ID# 217388	London
United Kingdom	University Hospital Plymouth NHS Trust /ID# 217390	Plymouth
United States	University of Colorado Hospital /ID# 215625	Aurora	Colorado
United States	University of Alabama at Birmingham - Main /ID# 215597	Birmingham	Alabama
United States	Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 215412	Boca Raton	Florida
United States	Baylor College of Medicine - Baylor Medical Center /ID# 215401	Houston	Texas
United States	Indiana Clinical Research Cent /ID# 216490	Indianapolis	Indiana
United States	Univ Kansas Med Ctr /ID# 215624	Kansas City	Kansas
United States	Booth Gardner Parkinson's Care Center /ID# 215535	Kirkland	Washington
United States	Dartmouth-Hitchcock Medical Center /ID# 216834	Lebanon	New Hampshire
United States	Legacy Medical Group - Neurology /ID# 215536	Portland	Oregon
United States	M3 Wake Research Inc. /ID# 215596	Raleigh	North Carolina
United States	Central Texas Neurology Consul /ID# 217013	Round Rock	Texas
United States	Washington University-School of Medicine /ID# 215472	Saint Louis	Missouri
United States	Univ Texas HSC San Antonio /ID# 215400	San Antonio	Texas
United States	Inland Northwest Research /ID# 215533	Spokane	Washington
United States	Banner Sun Health Res Inst /ID# 215579	Sun City	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Denmark,  Germany,  Italy,  Japan,  Netherlands,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
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 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
Primary	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
Primary	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	Average Normalized Daily "Off" Time	Average normalized daily "Off" Time (Hours) is assessed based on Parkinson's Disease (PD) Diary.	Up To Week 96
Secondary	Average Normalized Daily "On" Time	Average normalized daily "On" time is assessed based on Parkinson's Disease (PD) Diary.	Up To Week 96
Secondary	Parkinson's Disease (PD) Symptoms Measurement	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.	Up To Week 96
Secondary	Change From Baseline in Quality Of Life Measurement as Assessed by PD Questionnaire-39 (PDQ-39)	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.	Up To Week 96
Secondary	Change From Baseline in Health-related Quality Of Life Measurement as Assessed by EuroQol 5-dimensions questionnaire (EQ-5D-5L)	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).	Up To Week 96
Secondary	Cognitive Impairment Measurement	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.	Up To Week 96