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)
1 other identifier
observational
250
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Typical duration for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2023
CompletedFirst Posted
Study publicly available on registry
June 23, 2023
CompletedStudy Start
First participant enrolled
November 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
May 15, 2026
May 1, 2026
3.1 years
June 15, 2023
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
ABBV-951
Participants will receive ABBV-951 as prescribed by their physician.
Eligibility Criteria
Adult participants who are prescribed ABBV-951 for the treatment of advanced Parkinson's disease (aPD).
You may qualify if:
- 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.
You may not qualify if:
- Prior treatment with ABBV-951 for PD.
- Currently participating in interventional clinical trials.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (17)
Saiseikai Matsuyama Hospital /ID# 276259
Matsuyama, Ehime, 791-8026, Japan
National Hospital Organization Asahikawa Medical Center /ID# 269115
Asahikawa, Hokkaido, 070-0901, Japan
Hakodate Municipal Hospital /ID# 276757
Hakodate-shi, Hokkaido, 041-8680, Japan
Ryugasaki Saiseikai Hospital /ID# 264435
Ryūgasaki, Ibaraki, 305-0854, Japan
University of Tsukuba Hospital /ID# 268353
Tsukuba, Ibaraki, 305-8576, Japan
Okatsu Hospital /ID# 262781
Kagoshima, Kagoshima-ken, 890-0067, Japan
University Hospital Kyoto Prefectural University of Medicine /ID# 267445
Kyoto, Kyoto, 602-8566, Japan
Sendai Nishitaga National Hospital /ID# 268349
Sendai, Miyagi, 982-8555, Japan
Fujimoto General Hospital /ID# 277287
Miyakonojo-shi, Miyazaki, 885-0055, Japan
Shiga University of Medical Science Hospital /ID# 265637
Ōtsu, Shiga, 520-2192, Japan
Dokkyo Medical University Hospital /ID# 269116
Mibu, Tochigi, 321-0293, Japan
Juntendo University Hospital /ID# 264438
Bunkyo-ku, Tokyo, 113-8431, Japan
Nitobe Memorial Nakano General Hospital /ID# 275668
Nakano-ku, Tokyo, 164-0011, Japan
National Center of Neurology and Psychiatry - Kodaira /ID# 267372
Xiaoping City, Tokyo, 187-8551, Japan
National Hospital Organization Utano Hospital /ID# 268350
Kyoto, 616-8255, Japan
Okayama Neurology Clinic /ID# 269117
Okayama, 702-8005, Japan
Municipal Toyonaka Hospital /ID# 271277
Toyonaka, 560-0055, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2023
First Posted
June 23, 2023
Study Start
November 30, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
May 15, 2026
Record last verified: 2026-05