Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH

Wayne State University1 site in 1 country8 target enrollmentMarch 2013

ConditionsInfantile Spasms

InterventionsACTH

DrugsACTH

Overview

Phase: Phase 4
Intervention: ACTH
Conditions: Infantile Spasms
Sponsor: Wayne State University
Enrollment: 8
Locations: 1
Primary Endpoint: Neuroinflammation in cortical and/or subcortical structures
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to investigate the presence of neuroinflammation in children with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its response to ACTH treatment by repeating the PK PET scan after treatment.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

July 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wayne State University

Responsible Party

Principal Investigator

Harry T Chugani

Professor

Wayne State University

Eligibility Criteria

Inclusion Criteria

•A clinical diagnosis of 'cryptogenic IS'
•Normal MRI
•No other neurological disorder

Exclusion Criteria

•Abnormal MRI
•No anti-inflammatory medication 48 hrs prior to PK PET scans
•Parent/guardian unable to give written consent

Arms & Interventions

Infantile Spasms

Intervention: ACTH

Outcomes

Primary Outcomes

Neuroinflammation in cortical and/or subcortical structures

Time Frame: up to 6 weeks

Neuroinflammation in cortical and/or subcortical structures of the brain in patients with Infantile Spasms will be evaluated with 11-C-PK11195 PET scan at the baseline and 2 weeks after the completion of ACTH treatment (given over 4 weeks), i.e., 6 weeks after the baseline PET scan.