NCT00166621

Brief Summary

The purpose of this study is to determine the efficacy, safety, and population pharmacokinetics and determinants of drug responses to buspirone in children with autism using a randomized, double blind, cross over study in children ages 2 to 6 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

First QC Date

September 9, 2005

Last Update Submit

July 19, 2011

Conditions

Autism

Keywords

AutismNeuroplasticity

Outcome Measures

Primary Outcomes (4)

  • Safety will be measured by obtaining clinical laboratory tests, vital signs and evaluating probably or definitely related adverse events.

  • Population pharmacokinetics will be conducted to measure plasma concentrations in relation to the drug responses to buspirone.

  • The primary efficacy outcome will be the overall severity score from the Clinical Global Impressions assessment obtained from two raters, (parent and examiner)

  • Comparisons of allele, and genotype frequencies between responders and non-responders will be done for each polymorphism using Fisher's exact test to best predict response to buspirone.

Interventions

BuspironeDRUG

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meet study definition for the diagnosis of autistic disorder
  • Age 2 to 6 (male or female)
  • Informed Consent

You may not qualify if:

  • Clinical or lab evidence of renal or hepatic disease
  • Treatment with any medication known to alter the activity of the CYP3A4 enzyme including ketoconazole, itraconazole, grapefruit juice, erythromycin, clarithromycin, cimetidine, verapamil, diltiazem, rifampin, phenytoin, phenobarbital, or carbamazepine within the previous 3 months
  • Use of centrally acting drugs during the 6 weeks prior or during the study
  • Presence or history of neurological disorders, including seizure disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PET Center/Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

March 1, 2004

Study Completion

August 1, 2005

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

US(1)