RecruitingNCT05916157

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)

Sponsor

AbbVie

Enrollment

250 participants

Start Date

Nov 30, 2023

Study Type

OBSERVATIONAL

Conditions

Parkinson's Disease (PD)

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.

Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This observational study is following Japanese patients with advanced Parkinson's disease who have been prescribed ABBV-951 — a medication delivered continuously under the skin (subcutaneous infusion) to control motor fluctuations — to track real-world effectiveness and safety. **You may be eligible if...** - You have advanced Parkinson's disease - Your doctor has prescribed ABBV-951 as part of your standard care (per the approved label in Japan) - You are willing to give informed consent **You may NOT be eligible if...** - You have already been treated with ABBV-951 for Parkinson's disease - You are currently enrolled in another interventional clinical trial - You have conditions that make the subcutaneous infusion unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(16)

Saiseikai Matsuyama Hospital /ID# 276259

Matsuyama, Ehime, Japan

National Hospital Organization Asahikawa Medical Center /ID# 269115

Asahikawa, Hokkaido, Japan

Ryugasaki Saiseikai Hospital /ID# 264435

Ryūgasaki, Ibaraki, Japan

University of Tsukuba Hospital /ID# 268353

Tsukuba, Ibaraki, Japan

Okatsu Hospital /ID# 262781

Kagoshima, Kagoshima-ken, Japan

University Hospital Kyoto Prefectural University of Medicine /ID# 267445

Kyoto, Kyoto, Japan

Sendai Nishitaga National Hospital /ID# 268349

Sendai, Miyagi, Japan

Fujimoto General Hospital /ID# 277287

Miyakonojo-shi, Miyazaki, Japan

Shiga University of Medical Science Hospital /ID# 265637

Ōtsu, Shiga, Japan

Dokkyo Medical University Hospital /ID# 269116

Mibu, Tochigi, Japan

Juntendo University Hospital /ID# 264438

Bunkyo-ku, Tokyo, Japan

Nitobe Memorial Nakano General Hospital /ID# 275668

Nakano-ku, Tokyo, Japan

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

Xiaoping City, Tokyo, Japan

National Hospital Organization Utano Hospital /ID# 268350

Kyoto, Japan

Okayama Neurology Clinic /ID# 269117

Okayama, Japan

Municipal Toyonaka Hospital /ID# 271277

Toyonaka, Japan

View Full Details on ClinicalTrials.gov

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NCT05916157

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