A Study to Evaluate an Investigational Drug (NLY01)Treatment to be used in Early-Stage Parkinson’s Disease
Official Title: 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
This research is studying a new drug, NLY01, in a large number of persons to learn about its effects in people with early-stage Parkinson’s disease (PD). Researchers want to know whether NLY01 helps lessen symptoms and signs of early PD, as well as slow the progression of the disease.
You will have a 2 in 3 chance of receiving NLY01 and a 1 in 3 chance of receiving a placebo, sterile salt water that looks like NLY01 but does not contain the study drug.
The total amount of time for you to be in the study will be approximately 45 to 54 weeks.
- Man or woman, at least 30 to 80 years old
- Have early-stage Parkinson's disease
- Not be on any current treatments for PD
- If of reproductive potential, willing and able to use a highly effective form of birth control during the study and for 30 days following last dose of study material
* Other criteria for eligibility apply
- Diagnosis of secondary or atypical parkinsonism
- Onset of any parkinsonian motor sign or symptom >5 years before Screening Visit
- Previous surgical procedure for PD
- Clinically significant medical, surgical, psychiatric, or laboratory abnormality
- Has an ECG or clinical evidence of potentially unstable heart disease
- Medical or recreational use of marijuana or THC-containing compounds within 3 months of the Screening Visit
* Other criteria for exclusion apply