Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257046
• Other study ID #: ITI-214-105
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 28, 2017
• Est. completion date: September 28, 2018

Study information

• Verified date: December 2018
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 28, 2018
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Major Inclusion Criteria:

• Clinical diagnosis of idiopathic Parkinson's disease (PD)

• Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3

• Maintenance on stable PD therapy

Major Exclusion Criteria:

• Clinical signs of dementia

• Suicidal ideation or behavior

• Considered medically inappropriate for study participation

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• ITI-214
Oral

Other:
• Placebo
Oral

Locations

Country	Name	City	State
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Duke Early Phase Research Unit	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory biomarkers	Pharmacodynamics	7 days
Primary	Number of patients with reported or observed treatment-related adverse events	Safety and tolerability	7 days
Secondary	Maximum Plasma Concentration (Cmax)	Pharmacokinetics	7 days
Secondary	Area of the Curve (AUC)	Pharmacokinetics	7 days
Secondary	Motor and non-motor symptoms as assessed by the MDS-UPDRS	Pharmacodynamics	7 days