ABBV-951 Versus Oral Carbidopa/Levodopa
Condition: Parkinson’s disease
Key Inclusion Criteria:
- At least 30 years old with a diagnosis of idiopathic Parkinson’s disease (PD) that is responsive to levodopa
- Must be taking a minimum of 400 mg/day of levodopa equivalents and have motor symptoms inadequately controlled by current therapy, identifiable "off" and "on" states (motor fluctuations), and 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
- Patient or caregiver demonstrates the understanding and correct use of the study’s delivery system
Key Exclusion Criteria:
- Clinically significant, unstable medical conditions
- Recent history of drug or alcohol abuse that would interfere with study procedures
- History of allergic reaction or significant sensitivity to levodopa
Full Study Name
A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients (IRB no. 00000487)
The purpose of this study is to determine how well an investigational drug called ABBV-951 works to control Parkinson's disease symptoms compared to oral carbidopa (CD)/levodopa (LD). The study also aims to examine whether ABBV-951 is well-tolerated in individuals with Parkinson's disease. ABBV-951 is a solution of CD/LD.
After meeting the requirements for screening and the stabilization period, participants will be randomly assigned to one of two treatment groups. The first group will receive ABBV-951 solution and placebo (inactive substance) capsules, and the second group will receive placebo solution and CD/LD IR (immediate release) capsules. ABBV-951 and the placebo used in this study are delivered via a wearable pump that can be carried with the participant.