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

NCT ID: NCT03257046

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-28

Study Completion Date

2018-09-28

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multiple rising dose in sequential cohorts of 8 patients randomized in a 6:2 ratio to receive ITI-214 or placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 mg ITI-214

Administered once daily for 7 days

Group Type EXPERIMENTAL

ITI-214

Intervention Type DRUG

Oral

3 mg ITI-214

Administered once daily for 7 days

Group Type EXPERIMENTAL

ITI-214

Intervention Type DRUG

Oral

10 mg ITI-214

Administered once daily for 7 days

Group Type EXPERIMENTAL

ITI-214

Intervention Type DRUG

Oral

30 mg ITI-214

Administered once daily for 7 days

Group Type EXPERIMENTAL

ITI-214

Intervention Type DRUG

Oral

90 mg ITI-214

Administered once daily for 7 days

Group Type EXPERIMENTAL

ITI-214

Intervention Type DRUG

Oral

Placebo

Administered once daily for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral

Interventions

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ITI-214

Oral

Intervention Type DRUG

Placebo

Oral

Intervention Type OTHER

Eligibility Criteria

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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

Exclusion Criteria

* Clinical signs of dementia
* Suicidal ideation or behavior
* Considered medically inappropriate for study participation
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intra-Cellular Therapies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly Vanover, PhD

Role: STUDY_DIRECTOR

Intra-Cellular Therapies, Inc.

Locations

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Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

Duke Early Phase Research Unit

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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ITI-214-105

Identifier Type: -

Identifier Source: org_study_id