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Trial · Interventional

CompletedPhase 4Registry data

Evaluation of Neuroinflammation in Children With Infantile Spasms

NCTNCT02092883 (opens ClinicalTrials.gov in a new tab)Other id25QNC
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Overview

Status
Completed
Phase
Phase 4
Enrollment
8 participants (actual)
Sponsor
Wayne State University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Mar 2013
Primary completion
Jul 2016
Completion
Jul 2017
First posted
20 Mar 2014 (estimated)
Last update posted
7 Nov 2017
Conditions
Infantile Spasms

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201320142015201620172018
  1. Ph 4

    Evaluation of Neuroinflammation in Children With Infantile Spasms

    NCT02092883

    Mar 2013 to Jul 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ACTHDrug

Arms1

  • Experimental

    Infantile Spasms

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Neuroinflammation in cortical and/or subcortical structures

    Time frame · up to 6 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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