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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
John J Millichap, MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01367964
First received: June 3, 2011
Last updated: February 3, 2015
Last verified: February 2015
History of Changes
  Purpose
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 Intervention
West Syndrome
 Drug: adrenocorticotropin hormone

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Treatment of Infants at High Risk of Developing West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)

Resource links provided by NLM:

MedlinePlus related topics: Hormones
U.S. FDA Resources

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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).
Estimated Enrollment: 28
Study Start Date: July 2011
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility
Ages Eligible for Study:   2 Months to 12 Months   (Child)
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01367964

Contacts
Contact: John J. Millichap, MD 312-227-3540 jmillichap@luriechildrens.org
Contact: Sookyong Koh, MD, PhD 312-227-3540 skoh@luriechildrens.org

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: John J Millichap, MD    312-227-3540    jmillichap@luriechildrens.org   
Contact: Sookyong Koh, MD, PhD    312-227-3540    skoh@luriechildrens.org   
Principal Investigator: John J Millichap, MD         
Principal Investigator: Sookyong Koh, MD, PhD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Thrasher Research Fund
Investigators
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
  More Information

Publications:

Responsible Party: John J Millichap, MD, Attending Physician, Division of Neurology, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01367964     History of Changes
Other Study ID Numbers: 2011-14518 
Study First Received: June 3, 2011
Last Updated: February 3, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Hypsarrhythmia
Spasms, Infantile
West Syndrome

Additional relevant MeSH terms:
Syndrome
Spasms, Infantile
Disease
Pathologic Processes
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 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

ClinicalTrials.gov processed this record on September 28, 2016