Evaluation of Neuroinflammation in Children With Infantile Spasms

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.

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Key information

Conditions

Infantile Spasms Brain Diseases Central Nervous System Diseases Epilepsy Epilepsy, Generalized Epileptic Syndromes Inflammation Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spasms, Infantile

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTH

Drug

PK PET scan before and after ACTH treatment

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.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2017
First posted: Mar 20, 2014
Registry last updated: Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed