Evaluation of Neuroinflammation in Children With Infantile Spasms

Infantile Spasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092883
• Other study ID #: 25QNC
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2014
• Last updated: November 3, 2017
• Start date: March 2013
• Est. completion date: July 2017

Study information

• Verified date: November 2017
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infantile Spasms
• Muscle Cramp
• Spasm
• Spasms, Infantile

Intervention

Drug:
• ACTH
PK PET scan before and after ACTH treatment

Locations

Country	Name	City	State
United States	Children's Hospital of Michigan	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ajay Kumar, Vijay N. Tiwari, Otto Muzik, Pulak K. Chakraborty, Harry T Chugani. In-Vivo Measurement of Brain Inflammation with [11C]-[R]-PK-11195 Positron Emission Tomography in Children with Epileptic Disorders. Epilepsy Currents 2014;14:330 (abs)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroinflammation in cortical and/or subcortical structures	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.	up to 6 weeks