A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease (PD)

Treatments: Drug: ABBV-951

Study type: Interventional

Funder types: Industry

Identifiers

NCT03781167

M15-741

2018-002144-85 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).

This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

Enrollment: 244 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive
• Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion criteria

• Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study
• Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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244 participants in 2 patient groups

ABBV-951 Low Dose Subgroup

Experimental group

Description:

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was \< 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.

Treatment:

Drug: ABBV-951

ABBV-951 High Dose Subgroup

Experimental group

Description:

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.

Treatment:

Drug: ABBV-951