At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 244 enrolled
Drug / intervention
ABBV-951drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease
In Brief
A Phase 3 clinical trial evaluating ABBV-951 for Parkinson's Disease (PD). Completed, enrolled 244 participants across 65 sites in 13 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease (PD)
CountriesAustralia, Belgium, Canada, Denmark, Germany, Italy, Japan, Netherlands, Russia, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartApr 2019
Primary CompletionAug 2022
TodayJul 2026
First PostedDec 19, 2018
Enrollment StartApr 29, 2019
Primary CompletionAug 17, 2022
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.5 years ago
Interventions
ABBV-951drug
Solution for continuous subcutaneous infusion (CSCI)