Trial record 4 of 17 for:
"X-linked infantile spasm syndrome"
Evaluation of Neuroinflammation in Children With Infantile Spasms
Verified March 2014 by Wayne State University
Information provided by (Responsible Party):
Harry T Chugani, Wayne State University
First received: March 14, 2014
Last updated: March 18, 2014
Last verified: March 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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH
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:
| Study Start Date:
| Estimated Primary Completion Date:
||July 2015 (Final data collection date for primary outcome measure)
Experimental: Infantile Spasms
PK PET scan before and after ACTH treatment
|Genders Eligible for Study:
- A clinical diagnosis of 'cryptogenic IS'
- Normal MRI
- No other neurological disorder
- Abnormal MRI
- No anti-inflammatory medication 48 hrs prior to PK PET scans
- Parent/guardian unable to give written consent
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02092883
|Children's Hospital of Michigan
|Detroit, Michigan, United States, 48201 |
|Contact: Harry T Chugani, MD 313-993-2605 firstname.lastname@example.org |
|Principal Investigator: Ajay Kumar, MD,PhD,DNB |
|Principal Investigator: Harry T Chugani, MD |
Wayne State University
No publications provided
||Harry T Chugani, Professor, Wayne State University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 14, 2014
||March 18, 2014
||United States: Food and Drug Administration
Keywords provided by Wayne State University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs