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NCT00166595 · ClinicalTrials.gov registry record · Phase 1

Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)

A Phase 1 study of Child Development Disorders, Pervasive, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
Phase 1
Development phase
100
Enrollment target
4
Study locations

NCT00166595 is a Phase 1 study of Child Development Disorders, Pervasive that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 100 participants, above the 84-participant average among 4 other Child Development Disorders, Pervasive trials with a reported enrollment target (19% higher). The trial reports 4 study locations across 3 states.

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The verdict

NCT00166595, a Phase 1 study of Child Development Disorders, Pervasive, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
Phase 1
Development phase
100 participants
Enrollment target
4
Study locations

Study Summary

The purpose of this study is to determine if the known differences in genes influence drug metabolizing enzymes and receptors that are involved in risperidone drug action. The study will determine if differences in these genes will change the concentration of risperidone in the blood over time in children in relation to side effects and clinical response to risperidone.

Interventions

  • DRUG Risperidone

Study Locations (4)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • The Ohio State University Medical Center - Columbus

Michigan

  • Children's Hospital of Michigan/Wayne State University - Detroit

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2003-02
Est. Completion 2005-03
Phase Phase 1

What the Registry Record Tells You About NCT00166595

The ClinicalTrials.gov registry entry for NCT00166595 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 84-participant average among 4 other Child Development Disorders, Pervasive trials with a reported enrollment target (19% higher). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Child Development Disorders, Pervasive appearing as the primary indexed condition, and to 1 intervention - of which Risperidone is the first listed.

NCT00166595 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Michigan, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00166595 about?

NCT00166595 is a clinical study titled "Pharmacogenetics of Risperidone in Children With Pervasive Developmental Disorder (PDD)". The purpose of this study is to determine if the known differences in genes influence drug metabolizing enzymes and receptors that are involved in risperidone drug action. The study will determine if differences in these genes will change the concentration of risperidone in the blood over time in ch...

What is the current status of trial NCT00166595?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2003-02. Estimated completion is 2005-03.

What conditions does trial NCT00166595 study?

This clinical trial studies the following conditions: Child Development Disorders, Pervasive.

What interventions are being tested in trial NCT00166595?

The interventions under investigation include: Risperidone (DRUG).

Who is sponsoring clinical trial NCT00166595?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00166595 being conducted?

This trial has 4 study locations across Michigan, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.