Evaluation of Neuroinflammation in Children With Infantile Spasms

Phase 4

Completed

• Conditions: Infantile Spasms
• Interventions: Drug: ACTH

• Registration Number: NCT02092883
• Lead Sponsor: Wayne State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-18
• Study First Posted: 2014-03-20
• Primary Completion: 2016-07
• Study Completion: 2017-07
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-03
• Last Update Posted: 2017-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infantile Spasms	ACTH	-

Primary Outcome Measures

Name	Time	Method
Neuroinflammation in cortical and/or subcortical structures	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.

Trial Locations

Locations (1)

Children's Hospital of Michigan; 🇺🇸 Detroit, Michigan, United States