Clinical trial 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
Official title: A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson's Disease (aPD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's Disease (PD)
advanced Parkinson's disease (aPD)
ABBV-951
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 250
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants who are prescribed ABBV-951 for the treatment of advanced Parkinson's disease (aPD).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Experiencing Infusion Site Infections
timeFrame: Up to 52 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Matsuyama
country: Japan
facility: Saiseikai Matsuyama Hospital /ID# 276259
state: Ehime
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center /ID# 269115
state: Hokkaido
city: Ryugasaki
country: Japan
facility: Ryugasaki Saiseikai Hospital /ID# 264435
state: Ibaraki
city: Tsukuba-shi
country: Japan
facility: University of Tsukuba Hospital /ID# 268353
state: Ibaraki
city: Kagoshima-shi
country: Japan
facility: Okatsu Hospital /ID# 262781
state: Kagoshima
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 267445
state: Kyoto
city: Sendai
country: Japan
facility: Sendai Nishitaga National Hospital /ID# 268349
state: Miyagi
city: Miyakonojo-shi
country: Japan
facility: Fujimoto General Hospital /ID# 277287
state: Miyazaki
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital /ID# 265637
state: Shiga
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital /ID# 269116
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 264438
state: Tokyo
city: Nakano-ku
country: Japan
facility: Nitobe Memorial Nakano General Hospital /ID# 275668
state: Tokyo
city: Xiaoping City
country: Japan
facility: National Center of Neurology and Psychiatry - Kodaira /ID# 267372
state: Tokyo
city: Kyoto
country: Japan
facility: National Hospital Organization Utano Hospital /ID# 268350
city: Okayama
country: Japan
facility: Okayama Neurology Clinic /ID# 269117
city: Toyonaka
country: Japan
facility: Municipal Toyonaka Hospital /ID# 271277
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: