ABBV-951 Infusion for Parkinson's Disease

Not currently recruiting at 80 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Unsuitable candidate, 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 (PD), a brain condition causing symptoms like tremors and slow movement. The trial aims to determine if ABBV-951, administered as a continuous infusion under the skin, is safe and effective. Participants will receive this treatment for about 96 weeks, with regular hospital visits and check-ups. This trial is open to those who have completed specific previous studies on PD. Participants may experience more visits and assessments compared to usual care. As a Phase 3 trial, this is the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment for PD.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. It's 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?

Earlier research found that ABBV-951, a treatment for Parkinson's disease, is well-tolerated by patients. Reports show that over 2,100 people worldwide have used ABBV-951, and it has been approved in 34 countries, suggesting a good safety record. Although some side effects occurred, these studies primarily focused on the treatment's safety and tolerability. Results indicate that most patients managed the treatment without major issues. However, this treatment is still under study and not yet approved in the U.S. for Parkinson's disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Unlike traditional oral or injected medications for Parkinson's disease, ABBV-951 is administered through continuous subcutaneous infusion. This delivery method ensures a steady release of medication, which can help maintain more consistent symptom control throughout the day. Researchers are excited about ABBV-951 because it may offer improved management of motor fluctuations compared to current treatments like levodopa or dopamine agonists, potentially leading to better quality of life for patients.

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

Research has shown that ABBV-951, a new treatment administered as an infusion under the skin, offers potential benefits for people with advanced Parkinson's disease. In earlier studies, ABBV-951 improved patients' movement smoothness and reduced fluctuations in movement control compared to traditional oral medications. Patients using ABBV-951 also reported an enhanced overall quality of life. These findings suggest that ABBV-951 might manage some challenging symptoms of Parkinson's disease more effectively than current treatments. This offers hope that it could be a valuable option for those with advanced Parkinson's. Participants in this trial will receive ABBV-951 through continuous subcutaneous infusion for 96 weeks. ^{1 6 7 8 9}

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 M15-736 or M20-339 study. It's not open to those whom the investigator deems unsuitable for receiving ABBV-951.

Inclusion Criteria

Completion of the parent study, Study M15-736 or Study M20-339.

Exclusion Criteria

Participant considered by the investigator to be an unsuitable candidate 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 96 weeks

96 weeks

Regular visits at hospital or clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extended Treatment (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-951

Trial Overview The trial tests ABBV-951, an unapproved drug delivered as a continuous subcutaneous infusion over 96 weeks, potentially followed by an extended period. The focus is on safety and effectiveness in reducing Parkinson's symptoms.

How Is the Trial Designed?

Group I: ABBV-951 Experimental Treatment 1 Intervention

Participants will receive ABBV-951 by continuous subcutaneous infusion (CSCI) for 96 weeks during the Primary Treatment Period and during the optional Extended Treatment Period.

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/2021-10-28-AbbVie-Announces-ABBV-951-Foslevodopa-Foscarbidopa-Showed-Improvement-in-Controlling-Motor-Fluctuations-Compared-to-Oral-Levodopa-Carbidopa-Medication-in-Pivotal-Phase-3-Trial-in-Patients-with-Advanced-Parkinsons-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 advanced ...

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. 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 ...

8. 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 ...

9. 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 ...