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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT01367964
Date of registration:	03/06/2011
Prospective Registration:	Yes
Primary sponsor:	Ann & Robert H Lurie Children's Hospital of Chicago
Public title:	Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH) PREVENT-WS
Scientific title:	Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)
Date of first enrolment:	July 2011
Target sample size:	28
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT01367964
Study type:	Interventional
Study design:	Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
United States

Contacts

Name:	Sookyong Koh, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine

Name:	Doulgas R Nordli, Jr, MD
Address:
Telephone:
Email:
Affiliation:	Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine

Name:	John J. Millichap, MD
Address:
Telephone:
Email:
Affiliation:	Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine

Key inclusion & exclusion criteria

Inclusion criteria:

- Infants with pre-hypsarhythmia (Type 3 EEG) between 2 months to 12 months of age.

Exclusion criteria:

- Infants with any of the following diagnoses:

- A previous history of infantile spasms;

- Known inborn error of metabolism;

- Other symptomatic epileptic encephalopathy (e.g. Ohtahara syndrome).

Age minimum: 2 Months
Age maximum: 12 Months
Gender: All

Health Condition(s) or Problem(s) studied

West Syndrome

Intervention(s)

Drug: adrenocorticotropin hormone

Primary Outcome(s)

Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH. [Time Frame: 1 month]

Secondary Outcome(s)

Secondary ID(s)

2011-14518

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Thrasher Research Fund

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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