Intra-Cellular Therapies, Inc.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria, who are experiencing wearing off symptoms and levodopa-induced dyskinesia.
The study will be conducted in three periods: * Screening Period (up to 4 weeks) during which patient eligibility will be assessed; * Double-blind Treatment Period (4 weeks) in which all patients will be randomized to receive placebo or Lenrispodun 30 mg/day in 1:1 ratio. * Safety Follow-up Period (1 week) in which all patients will return to the clinic for a safety follow-up visit approximately one week after the last dose of study treatment.
Inclusion Criteria: 1. Male or female between 40 years of age and older 2. Body mass index of 19.0-40.0 kg/m2; 3. Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria; 4. Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state; 5. Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following: 1. Have been on a stable and optimal dose of levodopa (levodopa + DDCI combination: minimum dose of levodopa equivalent to 100 mg three times daily)…
Lenrispodun 30 mg tablets administered orally, once daily.
Matching tablets administered orally, once daily.