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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT02092883
Date of registration:	14/03/2014
Prospective Registration:	No
Primary sponsor:	Wayne State University
Public title:	Evaluation of Neuroinflammation in Children With Infantile Spasms
Scientific title:	Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH
Date of first enrolment:	March 2013
Target sample size:	8
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02092883
Study type:	Interventional
Study design:	Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
United States

Contacts

Key inclusion & exclusion 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

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Infantile Spasms

Intervention(s)

Drug: ACTH

Primary Outcome(s)

Neuroinflammation in cortical and/or subcortical structures [Time Frame: up to 6 weeks]

Secondary Outcome(s)

Secondary ID(s)

25QNC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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