An Open-Label Extension Of Study M15-736 To Evaluate The Safety And Tolerability Of 24-Hour Daily Exposure Of ABBV-951 In Subjects With Advanced Parkinson’s Disease
Sponsor:
Brief Summary:
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/carbidopa (LD/CD) 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 study will be enrolled. Approximately 130
participants will be enrolled in the study in approximately 80 sites in the United States and
Australia.
Participants will receive continuous subcutaneous infusion (CSCI) (under the skin) of
ABBV-951 for 96 weeks.
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.
Criteria
– Completion of the parent study, Study M15-736.
Exclusion Criteria:
– Participant considered by the investigator to be an unsuitable candidate to receive
ABBV-951 for any reason.
Locations
- Parkinson’s and Movement /ID# 217806, Fountain Valley, California, United States, 92708
- Neuro Pain Medical Center /ID# 217720, Fresno, California, United States, 93710-5473
- Loma Linda University Medical /ID# 217724, Loma Linda, California, United States, 92354
- Collaborative Neuroscience Net /ID# 222523, Long Beach, California, United States, 90806
- University of California, Los Angeles /ID# 218460, Los Angeles, California, United States, 90095
- SC3 Research Group – Pasadena /ID# 223018, Pasadena, California, United States, 91105-3149
- University of California, San /ID# 218595, San Diego, California, United States, 92037
- Cedars-Sinai Medical Center – West Hollywood /ID# 218607, West Hollywood, California, United States, 90048
