A Phase 1/2 interventional study of ITI-214 and Placebo in Parkinson Disease, sponsored by Intra-Cellular Therapies, Inc.. Completed at 2 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-12-20.
Sponsored by Intra-Cellular Therapies, Inc. · Phase 1/2, Interventional, and Treatment
This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ITI-214.
Major Inclusion Criteria:
Major Exclusion Criteria:
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Drug: ITI-214
Administered once daily for 7 days
Other: Placebo
Oral
Oral
Number of patients with reported or observed treatment-related adverse events
Safety and tolerability
Time frame: 7 days
Maximum Plasma Concentration (Cmax)
Pharmacokinetics
Time frame: 7 days
Area of the Curve (AUC)
Pharmacokinetics
Time frame: 7 days
Motor and non-motor symptoms as assessed by the MDS-UPDRS
Pharmacodynamics
Time frame: 7 days
Exploratory biomarkers
Pharmacodynamics
Time frame: 7 days
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Intra-Cellular Therapies, Inc.