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Trial record 1 of 1 for:    NCT01367964
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Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH) (PREVENT-WS)

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ClinicalTrials.gov Identifier: NCT01367964
Recruitment Status : Active, not recruiting
First Posted : June 7, 2011
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
John J Millichap, MD, Ann & Robert H Lurie Children's Hospital of Chicago

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.

Condition or disease Intervention/treatment Phase
West Syndrome Drug: adrenocorticotropin hormone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)
Study Start Date : July 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: ACTH treatment
Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.
Drug: adrenocorticotropin hormone
ACTH 16 units intramuscular injection once daily for 2 weeks
Other Name: H.P. Acthar® Gel (repository corticotropin injection)




Primary Outcome Measures :
  1. Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH. [ Time Frame: 1 month ]
    If pre-hypsarhythmia (Type 3) is detected, ACTH treatment is given for 2 weeks and an EEG is performed one month later. Primary outcome is improvement in EEG (as defined by assigned type).



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Ages Eligible for Study:   2 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367964


Locations
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United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Thrasher Research Fund
Investigators
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Principal Investigator: John J. Millichap, MD Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Principal Investigator: Sookyong Koh, MD, PhD Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Principal Investigator: Doulgas R Nordli, Jr, MD Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine

Additional Information:
Publications:
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Responsible Party: John J Millichap, MD, Attending Physician, Division of Neurology, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01367964    
Other Study ID Numbers: 2011-14518
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018
Keywords provided by John J Millichap, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
Hypsarrhythmia
Spasms, Infantile
West Syndrome
Additional relevant MeSH terms:
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Spasms, Infantile
Syndrome
Disease
Pathologic Processes
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epileptic Syndromes
Hormones
Adrenocorticotropic Hormone
Melanocyte-Stimulating Hormones
beta-Endorphin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action