Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease

Parkinson's Disease (PD) Clinical Trial

— ROSSINI  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06107426
• Other study ID #: P22-487
• Status: Recruiting
• Start date: January 24, 2024
• Est. completion date: May 13, 2029

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: Lars Bergmann
• Phone: +49(0)170 4538568
• Email: lars.bergmann[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting. ABBV-951 (foslevodopa/foscarbidopa) is an approved drug for the treatment of Parkinson's Disease. Approximately 450 adult participants with PD (300 participants new to ABBV-951, up to 150 participants transitioning from open-label extension study) will be enrolled across approximately 60 sites. Decision to treat with ABBV-951 (or continue the treatment in Cohort B) will be made by the doctor prior to any decision to approach the participant to participate in this study. All participants will receive subcutaneous infusion of ABBV-951 for approximately 3 years. Participants will attend regular clinic visits during the course of the study. The effect of the treatment will be checked by medical assessments, and completing questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: May 13, 2029
• Est. primary completion date: May 13, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease (PD)

Locations

Country	Name	City	State
Denmark	Rigshospitalet Glostrup /ID# 252035	Glostrup	Hovedstaden
Germany	Kliniken Beelitz GmbH /ID# 252665	Beelitz-Heilstaetten
Germany	Knappschaftskrankenhaus Bottrop /ID# 252274	Bottrop
Germany	Krankenhaus Martha-Maria Halle-Doelau /ID# 260372	Halle (Saale)	Sachsen-Anhalt
Germany	Klinikum Ernst von Bergmann /ID# 252375	Potsdam	Brandenburg
Germany	Parkinson-Klinik Ortenau GmbH & Co KG /ID# 252376	Wolfach
Spain	Hospital Universitario Virgen de las Nieves /ID# 257588	Granada
Spain	Hospital Universitario Virgen del Rocio /ID# 254437	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

Denmark,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in OFF Time (hours)	The mean change from baseline to each scheduled visit in the number of hours spent in OFF time will be estimated using a mixed-effect model repeated-measures (MMRM).	Up to approximately 3 years

External Links

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