ABBV-951 for Parkinson's Disease

Not currently recruiting at 97 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: ABBV-951

Disqualifiers: Not completed M15-741, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABBV-951 for individuals with advanced Parkinson's disease, which causes symptoms like tremors and slow movement. The researchers aim to determine if this drug, delivered through an infusion under the skin, is safe, effective, and tolerable, building on a previous study. Participants will receive the treatment continuously for 24 hours each day, with progress monitored through medical tests and assessments. This study targets those who completed the earlier ABBV-951 study and can manage the higher demands of regular clinic visits and remote check-ins. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that ABBV-951 is likely to be safe for humans?

Research has shown that ABBV-951, a new treatment for Parkinson's disease, has undergone safety evaluations. In one study, researchers monitored for safety issues and found none. Over 2,100 patients worldwide have started using ABBV-951, and it has received approval in 34 countries, suggesting it is considered safe.

ABBV-951 is administered as a continuous infusion under the skin, which might be more demanding than usual treatments. However, it aims to alleviate symptoms like tremors and stiffness, common in Parkinson's disease. While all treatments carry some risks, current data indicates that ABBV-951 is generally well-tolerated by patients. Regular check-ins during the trial will monitor any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABBV-951 for Parkinson's Disease because it offers a unique delivery method compared to current treatments. Unlike traditional oral medications, ABBV-951 is administered through continuous subcutaneous infusion, which can provide a steady release of medication, potentially leading to more consistent symptom control. This method could improve the quality of life for patients by reducing the fluctuations in symptoms that are common with current treatment options. Additionally, ABBV-951 may offer enhanced efficacy for advanced Parkinson's patients who no longer respond well to oral medications.

What evidence suggests that ABBV-951 might be an effective treatment for Parkinson's disease?

Research has shown that ABBV-951 could be a promising treatment for Parkinson's disease. Studies have found that it may improve patients' movement and enhance their quality of life. ABBV-951 combines two medicines, levodopa and carbidopa, administered as a continuous infusion under the skin. This method aims to maintain steady medication levels in the body, potentially reducing symptoms like tremors and stiffness. Although still under investigation, ABBV-951 has received approval in 34 countries, and over 2,100 patients have begun treatment worldwide. Early findings suggest that ABBV-951 might be effective and safe for many with advanced Parkinson's disease. ^{1 3 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults with advanced Parkinson's Disease who have already completed the parent study M15-741. They should be willing and able to follow the study procedures, including regular clinic visits and remote assessments.

Inclusion Criteria

Participants willing and able to comply with procedures required in the protocol

I have Parkinson's Disease and completed the M15-741 study.

Exclusion Criteria

Participants judged by the investigator to be unsuitable candidates to continue to receive ABBV-951 for any reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Primary Treatment

Participants receive continuous subcutaneous infusion of ABBV-951 for 24 hours daily

Up to 96 weeks

Regular clinic visits and remote assessments via phone calls

Extended Treatment (optional)

Participants may continue receiving ABBV-951 in an optional extended treatment period

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-951

Trial Overview The trial continues testing ABBV-951, an unapproved drug delivered as a continuous subcutaneous infusion over 24 hours daily. It aims to assess its safety, effectiveness, and tolerability in managing Parkinson's symptoms.

How Is the Trial Designed?

Group I: ABBV-951 Experimental Treatment 1 Intervention

Participants will receive ABBV-951 solution by continuous subcutaneous infusion (CSCI), at the discretion of the investigator, for up to 96 weeks.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06107426

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.

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=P22-487

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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04750226

NCT04750226 | Study To Assess Adverse Events and ... This study will assess how safe and effective ABBV-951 is in adult participants with PD. Adverse events and change in disease activity is evaluated.

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/08919887251335011

Efficacy and Safety of Novel Continuous Subcutaneous ... ND0612 and ABBV-951 are promising options for enhancing motor control and quality of life in PD patients.

5. news.abbvie.com news.abbvie.com/2024-06-25-AbbVie-Provides-U-S-Regulatory-Update-on-ABBV-951-Foscarbidopa-Foslevodopa

AbbVie 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 ...

6. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M15-741

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).

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40253616/

Efficacy and Safety of Novel Continuous Subcutaneous ... ConclusionsND0612 and ABBV-951 are promising options for enhancing motor control and quality of life in PD patients. However, further research ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04380142

NCT04380142 | Study Comparing Continuous ... Some symptoms of PD are tremors, stiffness, and slowness of movement. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral ...