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Evaluation of Neuroinflammation in Children With Infantile Spasms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02092883
Recruitment Status : Completed
First Posted : March 20, 2014
Last Update Posted : November 7, 2017
Information provided by (Responsible Party):
Harry T Chugani, 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
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
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2017

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

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT02092883

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

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Responsible Party: Harry T Chugani, Professor, Wayne State University Identifier: NCT02092883    
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
Additional relevant MeSH terms:
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Muscle Cramp
Spasms, Infantile
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Epileptic Syndromes