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

NCT ID: NCT05916157

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease (PD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ABBV-951

Participants will receive ABBV-951 as prescribed by their physician.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Saiseikai Matsuyama Hospital /ID# 276259

Matsuyama, Ehime, Japan

Site Status RECRUITING

National Hospital Organization Asahikawa Medical Center /ID# 269115

Asahikawa, Hokkaido, Japan

Site Status RECRUITING

Ryugasaki Saiseikai Hospital /ID# 264435

Ryūgasaki, Ibaraki, Japan

Site Status RECRUITING

University of Tsukuba Hospital /ID# 268353

Tsukuba, Ibaraki, Japan

Site Status RECRUITING

Okatsu Hospital /ID# 262781

Kagoshima, Kagoshima-ken, Japan

Site Status RECRUITING

University Hospital Kyoto Prefectural University of Medicine /ID# 267445

Kyoto, Kyoto, Japan

Site Status RECRUITING

Sendai Nishitaga National Hospital /ID# 268349

Sendai, Miyagi, Japan

Site Status RECRUITING

Fujimoto General Hospital /ID# 277287

Miyakonojo-shi, Miyazaki, Japan

Site Status RECRUITING

Shiga University of Medical Science Hospital /ID# 265637

Ōtsu, Shiga, Japan

Site Status RECRUITING

Dokkyo Medical University Hospital /ID# 269116

Mibu, Tochigi, Japan

Site Status RECRUITING

Juntendo University Hospital /ID# 264438

Bunkyo-ku, Tokyo, Japan

Site Status RECRUITING

Nitobe Memorial Nakano General Hospital /ID# 275668

Nakano-ku, Tokyo, Japan

Site Status RECRUITING

National Center of Neurology and Psychiatry - Kodaira /ID# 267372

Xiaoping City, Tokyo, Japan

Site Status RECRUITING

National Hospital Organization Utano Hospital /ID# 268350

Kyoto, , Japan

Site Status RECRUITING

Okayama Neurology Clinic /ID# 269117

Okayama, , Japan

Site Status RECRUITING

Municipal Toyonaka Hospital /ID# 271277

Toyonaka, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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AbbVie GK Clinical Trial Registration Desk

Role: CONTACT

+81-3-4577-1111

Related Links

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Other Identifiers

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P23-529

Identifier Type: -

Identifier Source: org_study_id

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