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

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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)

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

Trial documents
2

Trial contacts and locations

65

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Data sourced from clinicaltrials.gov

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