Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease
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
1 other identifier
interventional
40
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 parkinson-disease
Started Sep 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedStudy Start
First participant enrolled
September 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 28, 2018
CompletedDecember 20, 2018
December 1, 2018
11 months
August 14, 2017
December 18, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with reported or observed treatment-related adverse events
Safety and tolerability
7 days
Secondary Outcomes (3)
Maximum Plasma Concentration (Cmax)
7 days
Area of the Curve (AUC)
7 days
Motor and non-motor symptoms as assessed by the MDS-UPDRS
7 days
Other Outcomes (1)
Exploratory biomarkers
7 days
Study Arms (6)
1 mg ITI-214
EXPERIMENTALAdministered once daily for 7 days
3 mg ITI-214
EXPERIMENTALAdministered once daily for 7 days
10 mg ITI-214
EXPERIMENTALAdministered once daily for 7 days
30 mg ITI-214
EXPERIMENTALAdministered once daily for 7 days
90 mg ITI-214
EXPERIMENTALAdministered once daily for 7 days
Placebo
PLACEBO COMPARATORAdministered once daily for 7 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Clinical signs of dementia
- Suicidal ideation or behavior
- Considered medically inappropriate for study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Duke Early Phase Research Unit
Durham, North Carolina, 27708, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kimberly Vanover, PhD
Intra-Cellular Therapies, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2017
First Posted
August 22, 2017
Study Start
September 28, 2017
Primary Completion
September 6, 2018
Study Completion
September 28, 2018
Last Updated
December 20, 2018
Record last verified: 2018-12