ABBV-951 for Parkinson's Disease
(ROSSINI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the effectiveness of ABBV-951 for treating individuals with advanced Parkinson's disease (PD), a brain condition that causes tremors, stiffness, and slow movements. ABBV-951, administered as a subcutaneous infusion (a shot under the skin), is already approved for PD treatment, but this study examines its real-world application. Participants will receive the treatment for about three years and attend regular check-ups to monitor their progress. Suitable candidates are adults with PD who respond to levodopa, a common PD medication, and either have never used ABBV-951 or have used it in past studies without major issues. As a Phase 4 trial, this study highlights that ABBV-951 is already FDA-approved and proven effective, aiming to understand how the treatment benefits more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study doctor to understand how your current medications might interact with the trial treatment.
What is the safety track record for ABBV-951?
Research has shown that ABBV-951 (foslevodopa/foscarbidopa) is generally safe and well-tolerated by people with Parkinson's Disease. In a study with 141 participants at 57 locations, this treatment was compared to the usual oral medication, carbidopa/levodopa. The results focused on safety and tolerability, which were found to be acceptable.
ABBV-951 is approved in 34 countries, and over 2,100 patients worldwide have started using it. This wide approval suggests that the treatment has consistently demonstrated safety across different groups. While all medications can have side effects, the approval and widespread use of ABBV-951 indicate a reliable safety profile for most patients.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for Parkinson's disease, which often involve oral medications like levodopa, ABBV-951 is unique because it is delivered through a subcutaneous infusion. This method allows for continuous drug delivery, which can result in more stable drug levels and potentially better symptom control. Researchers are excited about ABBV-951 because it uses a prodrug of levodopa and carbidopa, which might offer improved absorption and fewer side effects compared to traditional oral formulations. This could mean a smoother management of symptoms for patients, reducing the fluctuations that many experience with current treatments.
What is the effectiveness track record for ABBV-951 in treating Parkinson's Disease?
Research has shown that ABBV-951, a treatment administered under the skin, effectively addresses advanced Parkinson's disease. Studies have found it manages movement problems better than traditional pills. Patients experienced improved movement, reduced stiffness, and fewer tremors. It also improved sleep and overall quality of life. These findings suggest that ABBV-951 offers significant benefits for those dealing with Parkinson's symptoms.678910
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous infusion of ABBV-951 for Parkinson's Disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-951
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Citations
NCT06107426 | Real-World Study of ABBV-951 ...
The purpose of this study is to evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting.
Real-World Study of ABBV-951 Subcutaneous Infusion to ...
Real-world study of ABBV-951 subcutaneous infusion to assess change in disease activity in adult participants with Parkinson's disease.
AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa ...
"These data are promising and demonstrate positive results on a key endpoint used to assess efficacy of treatments for patients with ...
Continuous Subcutaneous Foslevodopa/Foscarbidopa in ...
Reduction in early morning akinesia, improved sleep outcomes, and overall improvement in HRQoL measures are among the added benefits of ...
Efficacy and Safety of Novel Continuous Subcutaneous ...
On the foslevodopa/carbidopa ABBV-951 infusion, Aldred reported a mean (SD) change from baseline of −6.8 (13.6) at the end of 12 months. Soileau ...
NCT03781167 | A Study to Evaluate the Safety and ...
The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).
7.
news.abbvie.com
news.abbvie.com/2024-06-25-AbbVie-Provides-U-S-Regulatory-Update-on-ABBV-951-Foscarbidopa-FoslevodopaAbbVie Provides U.S. Regulatory Update on ABBV-951 ...
ABBV-951 has been approved in 34 countries and over 2,100 patients worldwide have started treatment. AbbVie continues to work with regulatory ...
A Study to Evaluate the Safety and Tolerability of ABBV ...
The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).
216962Orig1s000 - accessdata.fda.gov
efficacy, safety and tolerability of ABBV-951 to oral carbidopa/levodopa in advanced. Parkinson's disease patients”. Subjects: 141. Sites: 57 ...
Study Protocol
For details, please see the safety data in the ABBV-951 investigator's brochure.1. ABBV-951 metabolizes into LD and CD, sharing the same characteristics of ...
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