An Observational Study of Subcutaneous Infusion of ABBV-951 to Assess Change in Disease Activity and Adverse Events In Adult Japanese Participants With Advanced Parkinson's Disease

A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson's Disease (aPD)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05916157

Enrollment

250

Registered

2023-06-23

Start date

2023-11-30

Completion date

2027-01-01

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease (PD)

Keywords

Parkinson's Disease (PD), advanced Parkinson's disease (aPD), ABBV-951

Brief summary

Parkinson's disease (PD) is a neurological condition, which affects the brain. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to assess how safe and effective ABBV-951 is in treating participants with Parkinson's disease in real world setting. ABBV-951 is an approved drug being developed for the treatment of PD in Japan. Approximately 250 adult participants over 15 years with a diagnosis of PD who are prescribed ABBV-951 by their physicians will be enrolled in this study across Japan. Participants will receive ABBV-951 as prescribed their physician and followed for 52 weeks. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosed with advanced Parkinson's disease (aPD). * Prescribed ABBV-951 as physicians' decision according to the approved label for treatment of aPD. * Given informed consent (or by her/his legal representative, if it's a requirement from the participating hospital/clinic) for participating this study.

Exclusion criteria

* Prior treatment with ABBV-951 for PD. * Currently participating in interventional clinical trials.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Experiencing Infusion Site Infections	Up to 52 Weeks	Percentage of participants with infusion site infections following the commencement of ABBV-951 will be assessed.

Countries

Japan

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results