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NCT03257046 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Intra-Cellular Therapies.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT03257046 is a Phase 1 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 40 participants.

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The verdict

NCT03257046, a Phase 1 study, has completed, sponsored by Intra-Cellular Therapies.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study 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.

Interventions

  • OTHER Placebo
  • DRUG ITI-214

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-09-28
Est. Completion 2018-09-28
Phase Phase 1

Sponsor

Intra-Cellular Therapies

37 total trials

What the Registry Record Tells You About NCT03257046

The ClinicalTrials.gov registry entry for NCT03257046 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03257046 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03257046 about?

NCT03257046 is a clinical study titled "Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease". 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.

What is the current status of trial NCT03257046?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2017-09-28. Estimated completion is 2018-09-28.

What interventions are being tested in trial NCT03257046?

The interventions under investigation include: Placebo (OTHER), ITI-214 (DRUG).

Who is sponsoring clinical trial NCT03257046?

This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.