Observing the effects of ABBV-951 in adults with advanced Parkinson's disease
A Post-marketing Observational Study for ABBV-951 in Patients Diagnosed With Advanced Parkinson's Disease (aPD)
This study is testing how safe and effective a new treatment called ABBV-951 is for adults with advanced Parkinson's disease over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 16 sites (Matsuyama, Ehime and 15 other locations) |
| Trial ID | NCT05916157 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of ABBV-951 in treating adults with advanced Parkinson's disease in a real-world setting. Approximately 250 participants diagnosed with advanced Parkinson's disease will be enrolled across various locations in Japan, receiving ABBV-951 as prescribed by their physicians. Participants will be monitored for changes in disease activity and any adverse events over a period of 52 weeks, with study visits conducted either on-site or virtually. The study does not impose any additional burden on participants beyond standard care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with advanced Parkinson's disease who have been prescribed ABBV-951 by their physicians.
Not a fit: Patients who have previously been treated with ABBV-951 for Parkinson's disease or are currently participating in other interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of ABBV-951 for patients with advanced Parkinson's disease.
How similar studies have performed: While this study is observational and focuses on an approved drug, similar studies assessing real-world effectiveness of treatments for Parkinson's disease have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Matsuyama, Ehime and 15 other locations
- Saiseikai Matsuyama Hospital /ID# 276259 — Matsuyama, Ehime, Japan (Recruiting)
- National Hospital Organization Asahikawa Medical Center /ID# 269115 — Asahikawa, Hokkaido, Japan (Recruiting)
- Ryugasaki Saiseikai Hospital /ID# 264435 — Ryūgasaki, Ibaraki, Japan (Recruiting)
- University of Tsukuba Hospital /ID# 268353 — Tsukuba, Ibaraki, Japan (Recruiting)
- Okatsu Hospital /ID# 262781 — Kagoshima, Kagoshima-ken, Japan (Recruiting)
- University Hospital Kyoto Prefectural University of Medicine /ID# 267445 — Kyoto, Kyoto, Japan (Recruiting)
- Sendai Nishitaga National Hospital /ID# 268349 — Sendai, Miyagi, Japan (Recruiting)
- Fujimoto General Hospital /ID# 277287 — Miyakonojo-shi, Miyazaki, Japan (Recruiting)
- Shiga University of Medical Science Hospital /ID# 265637 — Ōtsu, Shiga, Japan (Recruiting)
- Dokkyo Medical University Hospital /ID# 269116 — Mibu, Tochigi, Japan (Recruiting)
- Juntendo University Hospital /ID# 264438 — Bunkyo-ku, Tokyo, Japan (Recruiting)
- Nitobe Memorial Nakano General Hospital /ID# 275668 — Nakano-ku, Tokyo, Japan (Recruiting)
- National Center of Neurology and Psychiatry - Kodaira /ID# 267372 — Xiaoping City, Tokyo, Japan (Recruiting)
- National Hospital Organization Utano Hospital /ID# 268350 — Kyoto, Japan (Recruiting)
- Okayama Neurology Clinic /ID# 269117 — Okayama, Japan (Recruiting)
- Municipal Toyonaka Hospital /ID# 271277 — Toyonaka, Japan (Recruiting)
Study contacts
- Study coordinator: AbbVie GK Clinical Trial Registration Desk
- Email: abbvie_jpn_info_clingov@abbvie.com
- Phone: +81-3-4577-1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.