An Open-Label Study in Subjects with Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient Setting (M15-739)
Neal Hermanowicz, MD
UCI Main Campus (Hewitt Hall & Gottschalk) and UC Irvine Medical Center
The purpose of this research study is to learn whether ABBV-951, a novel drug delivered subcutaneously during four weeks in subjects with Parkinson’s disease (PD), is locally and safe, well-tolerated and able to control PD symptoms at its best dose options (otherwise known as “titration”).
You can participate in this study if you:
- Are between 30 and 85 years old, inclusive.
- Have been diagnosed with Parkinson’s disease and are responsive to levodopa treatment.
- Are currently taking carbidopa/levodopa orally.
- Are able to recognize “ON” and “OFF” states (motor fluctuations) and have a minimum of 2.5 hours of “OFF” time per day.
You cannot participate in this study if you:
- Have any skin conditions or disorders that may interfere with study procedures.
- Have any other clinically significant unstable medical conditions.
- Are currently taking any prohibited medications such as, but not limited to: apomorphine, reserpine, tetrabenazine, amphetamines, fluphenazine, loxapine, haloperidol, clonidine, doxazosin. Please note that this is not a complete list of prohibited medications for this study. The study team will provide you with a complete list of medications that are not allowed for this study.
Your participation in this study will last between 38 to 58 days, depending on how long you have been taking the current doses of your medications for Parkinson’s disease. Your PD medications have to remain unchanged for at least 30 days before you begin participating in this study. This study will involve eight required clinic visits with the possibility of three additional clinic visits during Study Days 3-5, which is part of the “Titration Period.”
While researchers hope ABBV-951 will be more effective than the standard (usual) treatment, there is no proof of this yet. Therefore, the Parkinson’s symptoms may or may not improve in response to the treatment.
You will not be paid for taking part in this study. You may have some expenses from being in the study, such as travel expenses, hotel bills, bus fare or parking fees when you visit the study center. You will be reimbursed for these expenses.
Breana Chew, Department of Neurology Clinical Trials Unit