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NCT Number: NCT05916157

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) 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Parkinson's Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saiseikai Matsuyama Hospital /ID# 276259, Matsuyama, Ehime, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Percentage of Participants Experiencing Infusion Site Infections

    Time frame: Up to 52 Weeks

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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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