ABBV-951 for Parkinson's Disease

Recruiting at 82 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

130 Participants Needed

Trial Summary

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.

What is the purpose of this trial?

This trial is testing a new drug called ABBV-951 for adults with advanced Parkinson's disease. The drug is given in a way to help control symptoms. Participants will be monitored through periodic check-ins to ensure the drug's safety and effectiveness.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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