Study of an extended-release investigational drug for the treatment of Parkinson's disease
Researchers want to find out if an investigational drug can help people with Parkinson's disease. The study drug is being tested to see if it is safe and tolerable, and to see if it relieves the symptoms of Parkinson's disease. Interested subjects will be screened for eligibility. Those who meet entry criteria will be enrolled in the study and randomly (like a flip of a coin) assigned to 1 of 4 doses of active study drug or to placebo. A placebo is a capsule that looks like the study drug but has no active ingredient. It is planned that about 350 people with Parkinson's disease will be in this study in up to 34 research centers (up to 8 subjects may be enrolled at Rush University Medical Center). Participation in this study will last for up to 33 weeks and subjects will be required to come to the medical center for at least 7 study visits.
You may be eligible to participate in this study if you:
-
Diagnosed with idiopathic Parkinson's disease
-
Male or female at least 30 years old at the time of PD diagnosis
-
No exposure to levodopa or certain other medications for more than 30 days and not within 4 weeks prior to study enrollment
-
Able to understand and willing to provide written informed consent to participate
You will be excluded from this study if you:
-
Pregnant or breastfeeding
-
Diagnosed with atypical Parkinsonism or any known secondary parkinsonian syndrome
-
Prior functional neurosurgical treatment for PD or if such procedures are anticipated during study participation
-
Use of nonselective MAO inhibitors
-
Use of dopamine agonists 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 e-mail, please include the title of the study in your message.