Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease

AbbVie

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease (PD)

Treatments: Drug: Placebo for Levodopa/Carbidopa (LD/CD); Drug: Levodopa/Carbidopa (LD/CD); Drug: Placebo for ABBV-951; Drug: ABBV-951

Study type: Interventional

Funder types: Industry

Identifiers

NCT04380142

M15-736

2019-003930-18 (EudraCT Number)

Details and patient eligibility

About

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. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in advanced PD participants to achieve reduction in motor fluctuations.

ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world.

In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Enrollment: 174 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive.
• Participant must be taking a minimum of 400 milligrams/day (mg/day) of Levodopa (LD) equivalents and be judged by the investigator to have motor symptoms inadequately controlled by current therapy, have a recognizable/identifiable "Off" and "On" states (motor fluctuations), and have an average "Off" time of at least 2.5 hours/day over 3 consecutive PD Diary days with a minimum of 2 hours each day.
• Participant or caregiver, if applicable, demonstrates the understanding and correct use of the delivery system, including the insertion of the cannula into the participant's abdomen, as assessed by the investigator or designee during the Screening period.

Exclusion criteria

• Clinically significant, unstable medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study drug.
• History of allergic reaction or significant sensitivity to LD or constituents of the study drug (and its excipients) and/or other products in the same class.
• Participant has not received deep brain stimulation, CD/LD enteral suspension, or any other PD medication as continuous daily infusion, whether commercially available or investigational. Previous exposure to ABBV-951 is not allowed.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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174 participants in 2 patient groups

ABBV-951 + Placebo for Levodopa/Carbidopa (LD/CD)

Experimental group

Description:

After an open-label LD/CD Stabilization Period, participants will receive double-blind ABBV-951 by continuous subcutaneous infusion (CSCI) and oral placebo for LD/CD for 12 weeks

Treatment:

Drug: ABBV-951

Drug: Placebo for Levodopa/Carbidopa (LD/CD)

Levodopa/Carbidopa (LD/CD) + Placebo for ABBV-951

Active Comparator group

Description:

After an open-label LD/CD Stabilization Period, participants will receive double-blind oral LD/CD and CSCI of placebo for ABBV-951 for 12 weeks

Treatment:

Drug: Placebo for ABBV-951

Drug: Levodopa/Carbidopa (LD/CD)