Parkinson's Disease (PD)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
An observational study of Parkinson's Disease (PD), run by AbbVie at 17 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Parkinson's Disease (PD)
- How many people
- 250 participants
- Where
- 17 sitesJapan
- Study dates
- 30 Nov 2023to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult participants who are prescribed ABBV-951 for the treatment of advanced Parkinson's disease (aPD).
Who may be able to join
- 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.
Who cannot join
- Prior treatment with ABBV-951 for PD.
- Currently participating in interventional clinical trials.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
National Hospital Organization Asahikawa Medical Center /ID# 269115
Asahikawa, Hokkaido, 070-0901
Juntendo University Hospital /ID# 264438
Bunkyo-ku, Tokyo, 113-8431
Hakodate Municipal Hospital /ID# 276757
Hakodate-shi, Hokkaido, 041-8680
Okatsu Hospital /ID# 262781
Kagoshima, Kagoshima-ken, 890-0067
University Hospital Kyoto Prefectural University of Medicine /ID# 267445
Kyoto, Kyoto, 602-8566
National Hospital Organization Utano Hospital /ID# 268350
Kyoto, 616-8255
Saiseikai Matsuyama Hospital /ID# 276259
Matsuyama, Ehime, 791-8026
Dokkyo Medical University Hospital /ID# 269116
Mibu, Tochigi, 321-0293
Fujimoto General Hospital /ID# 277287
Miyakonojo-shi, Miyazaki, 885-0055
Nitobe Memorial Nakano General Hospital /ID# 275668
Nakano-ku, Tokyo, 164-0011
Okayama Neurology Clinic /ID# 269117
Okayama, 702-8005
Shiga University of Medical Science Hospital /ID# 265637
Ōtsu, Shiga, 520-2192
Ryugasaki Saiseikai Hospital /ID# 264435
Ryūgasaki, Ibaraki, 305-0854
Sendai Nishitaga National Hospital /ID# 268349
Sendai, Miyagi, 982-8555
Municipal Toyonaka Hospital /ID# 271277
Toyonaka, 560-0055
University of Tsukuba Hospital /ID# 268353
Tsukuba, Ibaraki, 305-8576
National Center of Neurology and Psychiatry - Kodaira /ID# 267372
Xiaoping City, Tokyo, 187-8551
About this study
Official title: A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson's Disease (aPD)
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.
Read more
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.
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's Disease (PD), advanced Parkinson's disease (aPD), ABBV-951
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ABBV-951 | Participants will receive ABBV-951 as prescribed by their physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Infusion Site Infections
Percentage of participants with infusion site infections following the commencement of ABBV-951 will be assessed.
Measured: Up to 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start30 Nov 2023
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916157
- Sponsor's protocol ID
- P23-529
- Status last verified
- May 2026
- First submitted
- 15 Jun 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson's Disease (aPD)
- ClinicalTrials.gov ID
- NCT05916157
- Acronym / sponsor ID
- P23-529
- Conditions
- Parkinson's Disease (PD)
- Keywords
- Parkinson's Disease (PD), advanced Parkinson's disease (aPD), ABBV-951
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABBV-951 | – | –Participants will receive ABBV-951 as prescribed by their physician. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult participants who are prescribed ABBV-951 for the treatment of advanced Parkinson's disease (aPD).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Prior treatment with ABBV-951 for PD.
- Currently participating in interventional clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease (PD), run by AbbVie at 17 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Infusion Site Infections (time frame: Up to 52 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.