Safety and Efficacy Study of an Extended Release Treatment for Levodopa-Induced Dyskinesia in Parkinson’s Disease
This study will evaluate the safety, effectiveness and tolerability of three dose levels of an extended release treatment of levodopa-induced dyskineisa (LID). The three doses of the study drug are similar to doses of an already approved by the FDA for treatment of PD; however doses in this study are higher than those usually prescribed for PD. One of the goals of this clinical study is to understand what dose of study drug may work best for treatment of LID. It is anticipated that 80 subjects will participate in this study at about 25 centers (with up to four subjects at Rush). Subjects who agree to participate will be in the study for about three months, will need to come to Rush for eight study visits and will have one telephone visit.
You may be eligible to participate in this study if you:
- Have a diagnosis of Parkinson disease
- Are 30 to 80 years of age, inclusive
- Are ambulatory or ambulatory-aided (e.g., walker or cane) ability while ON, such that study assessment can be completed.
- Have a knowledgeable and reliable caregiver/study partner who can accompany you to study visits and assist with completion of study instruments, as needed and allowed.
- Have followed a stable regime of antiparkinson medication for at least 30 days prior to screening
You will be excluded from this study if you:
- Have secondary or atypical parkinsonism
- Have a history of neurosurgical intervention for Parkinson disease
- Have been treated with any other investigational drugs or investigational devices within 30 days prior to screening
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.