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Evaluating ABBV-951 for treating advanced Parkinson's Disease in adults

A Global Real-World Evidence Study on the Long-term Effectiveness of ABBV-951 in Advanced Parkinson´s Disease in Routine Clinical Practice (ROSSINI: Real-world Outcomes With continuouS Subcutaneous Levodopa INfusIon)

Observational AbbVie · NCT06107426

This study is testing a treatment called ABBV-951 to see how well it works for adults with advanced Parkinson's Disease in everyday settings.

Quick facts

Study typeObservational
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Locations54 sites (Sun City, Arizona and 53 other locations)
Trial IDNCT06107426 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of ABBV-951, a treatment for advanced Parkinson's Disease (PD), in a real-world setting. Approximately 450 adult participants will be enrolled across 60 sites, with some being new to ABBV-951 and others transitioning from previous studies. The decision to treat with ABBV-951 will be made by the treating physician prior to participant enrollment. Additionally, a sub-study will include 40 participants who are naïve to ABBV-951 treatment.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with levodopa-responsive idiopathic Parkinson's Disease who are either naïve to ABBV-951 or transitioning from previous studies.

Not a fit: Patients who do not meet the eligibility criteria for ABBV-951 therapy or those with significant safety risks from prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the real-world effectiveness of ABBV-951 for managing advanced Parkinson's Disease symptoms.

How similar studies have performed: Other studies evaluating treatments for Parkinson's Disease have shown varying degrees of success, but this specific approach with ABBV-951 is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Eligibility for ABBV-951 therapy in accordance with the approved local label in the participating country and local reimbursement regulations, if applicable.
* Diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD).
* Participant must be either:

  * Cohort A: Naïve to ABBV-951
  * Cohort B: Pre-treated with ABBV-951, specifically, participants of Open-Label Extension Studies M15-737 and M20-098 who completed these studies without significant protocol deviations and who did not experience an adverse event (AE) that in the investigator's opinion may indicate an unacceptable safety risk.
* Decision to treat with ABBV-951 (or continue the treatment in Cohort B) made by the clinician prior to any decision to approach the participant to participate in this study.
* Prior to any study-related procedures being performed, the participant, or legal authorized representative (LAR) has voluntarily signed an Authorization for Use/Disclosure of Data (AUDD)/informed consent form (ICF) according to national regulations after the study has been explained and the participant has had the opportunity to have questions answered.

Exclusion Criteria:

* Any condition included in the contraindications section of the approved local ABBV-951 label in the participating country.
* Mini-Mental State Examination (MMSE) score \< 24.

  * If the participant has a score of 19-23, he/she can be included if based on the investigator´s judgment the participant is able to handle the therapy and follow the study procedures with the help of a permanent caregiver.
* Participation in a concurrent interventional clinical trial from enrollment and throughout the study.
* History of significant skin conditions or disorders per investigator´s judgment. In case of temporary affections like recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations, the participant should not be included if the investigator considers these as interfering with the infusion of study drug or with study assessments.

Where this trial is running

Sun City, Arizona and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Parkinson's DiseaseAdvance Parkinson's DiseaseABBV-951Foslevodopa/foscarbidopa
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.