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Active (not recruiting) Phase 3 NCT04379050

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

Phase 3 – large-scale trial before approval
Conditions: Parkinson's Disease (PD)

Sponsor: AbbVie

trial.available_in: БГ
Overview
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.
Who can participate
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.
Locations 12
Australia (1)
Concord Repatriation General Hospital /ID# 215943
Concord , New South Wales
Belgium (1)
Universitair Ziekenhuis Leuven /ID# 215684
Leuven , Vlaams-Brabant
Canada (1)
University of Calgary /ID# 215369
Calgary , Alberta
Denmark (1)
Bispebjerg and Frederiksberg Hospital /ID# 215391
Copenhagen NV , Capital Region
Italy (1)
IRCCS Centro Neurolesi Bonino Pulejo /ID# 215422
Messina
Japan (1)
National Hospital Organization Asahikawa Medical Center /ID# 218762
Asahikawa-shi , Hokkaido
Netherlands (1)
St. Antonius Ziekenhuis /ID# 215396
Nieuwegein , Utrecht
Russia (1)
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 218869
Saint Petersburg , Sankt-Peterburg
Spain (1)
Complejo Hospitalario Universitario A Coruña /ID# 215426
A Coruña , A Coruna
Sweden (1)
Skane University Hospital Lund /ID# 215385
Lund , Skåne County
United Kingdom (1)
Derriford Hospital and the Royal Eye Infirmary /ID# 217390
Plymouth , Devon
United States (1)
University of Alabama at Birmingham - Main /ID# 215597
Birmingham , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
30 Years
Healthy volunteers
No
Start date
08.06.2020
Completion date
01.04.2026
Registry ID
NCT04379050
Source
anzctr
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