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NCT05916157 Clinical Trial

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

Parkinson's Disease (PD) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05916157
Other study ID # P23-529
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 30, 2023
Est. completion date July 5, 2026

Study information
Verified date April 2024
Source AbbVie
Contact AbbVie GK Clinical Trial Registration Desk
Phone +81-3-4577-1111
Email abbvie_jpn_info_clingov@abbvie.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date July 5, 2026
Est. primary completion date July 5, 2026
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Okatsu Hospital /ID# 262781 Kagoshima-shi Kagoshima
Japan University Hospital, Kyoto Prefectural University of Medicine /ID# 267445 Kyoto
Japan Shiga Medical University Hospital /ID# 265637 Otsu Shiga
Japan Ryugasaki Saiseikai Hospital /ID# 264435 Ryugasaki Ibaraki
Japan Juntendo University Hospital /ID# 264438 Tokyo

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

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