Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

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Brief Title

Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

Official Title

Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

Brief Summary

      West syndrome (WS) is a specific type of epilepsy (or seizure disorder) that has three
      features: infantile spasms (type of seizure), loss of milestones, and a specific pattern on
      electroencephalogram (EEG or brain wave test) called hypsarhythmia. The purpose of this study
      is to detect pre-hypsarhythmia in infants at high-risk for WS and determine whether treatment
      with ACTH will prevent WS.
    

Detailed Description

      Hypothesis: Preemptive ACTH will halt the evolution of hypsarhythmia and improve the EEG
      patterns in infants with pre-hypsarhythmic EEG.

      Aim. To determine whether a low dose ACTH improves EEG, we will repeat EEG one month after a
      2 week course of daily ACTH.
    


Study Type

Interventional


Primary Outcome

Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.


Condition

West Syndrome

Intervention

adrenocorticotropin hormone

Study Arms / Comparison Groups

 ACTH treatment
Description:  Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

28

Start Date

July 2011

Completion Date

December 2018

Primary Completion Date

December 2018

Eligibility 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).
      

Gender

All

Ages

2 Months - 12 Months

Accepts Healthy Volunteers

No

Contacts

John J. Millichap, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01367964

Organization ID

2011-14518


Responsible Party

Principal Investigator

Study Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

 Thrasher Research Fund

Study Sponsor

John J. Millichap, MD, Principal Investigator, Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine


Verification Date

November 2018