Evaluation of Neuroinflammation in Children With Infantile Spasms

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02092883

Enrollment

Registered

2014-03-20

Start date

2013-03-31

Completion date

2017-07-31

Last updated

2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile Spasms

Keywords

Infantile Spasms, Neuroinflammation, PK11195, PET, ACTH

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.

Interventions

DRUGACTH

PK PET scan before and after ACTH treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026