Multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of 36 weeks of treatment with NLY01 in early-stage Parkinson’s disease.
The Booth Gardner Parkinson’s Care Center is conducting a study to determine the effectiveness of a study drug relative to placebo in patients with Parkinson’s disease (PD). Study drug or placebo will be given as a weekly subcutaneous injection over 36 weeks.
Who may be eligible to participate?
Subjects 30 to 80 years of age (inclusive) with a confirmed diagnosis of PD. Onset of any parkinsonian motor sign or symptom must be within 5 years before the Screening Visit. Other inclusion/exclusion criteria apply.
What does participation involve?
Participation in this study will involve subjects attending 10 in-person study visits. After instruction, subjects will self-administer the study drug subcutaneously once per week for 36 weeks (36 doses) with safety follow-up visits approximately 4 weeks and 8 weeks after last injection.
Daniel Burdick, MD, Booth Gardner Parkinson’s Care Center