Evaluation of Neuroinflammation in Children With Infantile Spasms

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Wayne State University
Information provided by (Responsible Party):
Harry T Chugani, Wayne State University
ClinicalTrials.gov Identifier:
First received: March 14, 2014
Last updated: December 17, 2014
Last verified: December 2014

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.

Condition Intervention Phase
Infantile Spasms
Drug: ACTH
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH

Resource links provided by NLM:

Further study details as provided by Wayne State University:

Primary Outcome Measures:
  • Neuroinflammation in cortical and/or subcortical structures [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 10
Study Start Date: March 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infantile Spasms Drug: ACTH
PK PET scan before and after ACTH treatment


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02092883

United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Harry T Chugani, MD    313-993-2605    hchugani@pet.wayne.edu   
Principal Investigator: Ajay Kumar, MD,PhD,DNB         
Principal Investigator: Harry T Chugani, MD         
Sponsors and Collaborators
Wayne State University
  More Information

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)

Responsible Party: Harry T Chugani, Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT02092883     History of Changes
Other Study ID Numbers: 25QNC
Study First Received: March 14, 2014
Last Updated: December 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Wayne State University:
Infantile Spasms

Additional relevant MeSH terms:
Spasms, Infantile
Brain Diseases
Central Nervous System Diseases
Epilepsy, Generalized
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 09, 2015