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Evaluation of Neuroinflammation in Children With Infantile Spasms

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ClinicalTrials.gov Identifier: NCT02092883
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Infantile Spasms Drug: ACTH Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH
Study Start Date : March 2013
Primary Completion Date : July 2016
Study Completion Date : July 2017


Arms and Interventions

Arm Intervention/treatment
Experimental: Infantile Spasms Drug: ACTH
PK PET scan before and after ACTH treatment


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02092883


Locations
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Wayne State University
More Information

Publications:
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
First Posted: March 20, 2014    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by Harry T Chugani, Wayne State University:
Infantile Spasms
Neuroinflammation
PK11195
PET
ACTH

Additional relevant MeSH terms:
Spasm
Muscle Cramp
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
PK 11195
Antineoplastic Agents