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Trial record 12 of 13 for:    epilepsy Michigan | Recruiting, Not yet recruiting, Available Studies

Evaluation of Neuroinflammation in Children With Infantile Spasms

This study is currently recruiting participants.
Verified January 2016 by Harry T Chugani, Wayne State University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02092883
First Posted: March 20, 2014
Last Update Posted: January 8, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Harry T Chugani, Wayne State University
  Purpose
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: None (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 Harry T Chugani, Wayne State University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: March 2013
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infantile Spasms Drug: ACTH
PK PET scan before and after ACTH treatment

  Eligibility

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 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

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 Submitted: March 14, 2014
First Posted: March 20, 2014
Last Update Posted: January 8, 2016
Last Verified: January 2016

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

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