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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

Recruiting
Conditions
Parkinson's Disease (PD)
Registration Number
NCT05916157
Lead Sponsor
AbbVie
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
250
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Experiencing Infusion Site InfectionsUp to 52 Weeks

Percentage of participants with infusion site infections following the commencement of ABBV-951 will be assessed.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (15)

Municipal Toyonaka Hospital /ID# 271277

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Toyonaka, Japan

Saiseikai Matsuyama Hospital /ID# 276259

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Matsuyama, Ehime, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 267445

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Kyoto-shi, Kyoto, Japan

National Hospital Organization Asahikawa Medical Center /ID# 269115

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Asahikawa, Hokkaido, Japan

Ryugasaki Saiseikai Hospital /ID# 264435

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Ryugasaki, Ibaraki, Japan

University of Tsukuba Hospital /ID# 268353

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Tsukuba-shi, Ibaraki, Japan

Okatsu Hospital /ID# 262781

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Kagoshima-shi, Kagoshima, Japan

Sendai Nishitaga National Hospital /ID# 268349

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Sendai, Miyagi, Japan

Shiga University of Medical Science Hospital /ID# 265637

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Otsu, Shiga, Japan

Dokkyo Medical University Hospital /ID# 269116

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Mibu, Tochigi, Japan

Juntendo University Hospital /ID# 264438

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Bunkyo-ku, Tokyo, Japan

Nitobe Memorial Nakano General Hospital /ID# 275668

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Nakano-ku, Tokyo, Japan

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

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Xiaoping City, Tokyo, Japan

National Hospital Organization Utano Hospital /ID# 268350

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Kyoto, Japan

Okayama Neurology Clinic /ID# 269117

πŸ‡―πŸ‡΅

Okayama, Japan

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