M15-737 - extension SC ABBV-951 in subjects with Parkinson's disease
Research type
Research Study
Full 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.
IRAS ID
284577
Contact name
K. Ray Chaudhuri
Contact email
Sponsor organisation
Abbvie Deutschland GmbH & Co. KG
Eudract number
2019-004235-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 15 days
Research 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 for 96 weeks or until premature discontinuation. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and remote assessments during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0291
Date of REC Opinion
15 Sep 2020
REC opinion
Further Information Favourable Opinion