Prevention of West Syndrome With Low-dose Adrenocorticotropin Hormone (ACTH)
NCT ID: NCT01367964
Last Updated: 2018-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
28 participants
INTERVENTIONAL
2011-07-31
2018-12-31
Brief Summary
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Detailed Description
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Aim. To determine whether a low dose ACTH improves EEG, we will repeat EEG one month after a 2 week course of daily ACTH.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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ACTH treatment
Infants with a Type 3 EEG (pre-hypsarhythmia) will be treated with ACTH for 2 weeks.
adrenocorticotropin hormone
ACTH 16 units intramuscular injection once daily for 2 weeks
Interventions
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adrenocorticotropin hormone
ACTH 16 units intramuscular injection once daily for 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* A previous history of infantile spasms;
* Known inborn error of metabolism;
* Other symptomatic epileptic encephalopathy (e.g. Ohtahara syndrome).
2 Months
12 Months
ALL
No
Sponsors
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Thrasher Research Fund
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Responsible Party
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John J Millichap, MD
Attending Physician, Division of Neurology
Principal Investigators
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John J. Millichap, MD
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Sookyong Koh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Doulgas R Nordli, Jr, MD
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H. Lurie Children's Hospital of Chicago and Northwestern University Feinberg School of Medicine
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Countries
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References
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SOREL L, DUSAUCY-BAULOYE A. [Findings in 21 cases of Gibbs' hypsarrhythmia; spectacular effectiveness of ACTH]. Acta Neurol Psychiatr Belg. 1958 Feb;58(2):130-41. No abstract available. French.
Okumura A, Watanabe K. Clinico-electrical evolution in pre-hypsarrhythmic stage: towards prediction and prevention of West syndrome. Brain Dev. 2001 Nov;23(7):482-7. doi: 10.1016/s0387-7604(01)00291-1.
Suzuki M, Okumura A, Watanabe K, Negoro T, Hayakawa F, Kato T, Itomi K, Kubota T, Maruyama K. The predictive value of electroencephalogram during early infancy for later development of West syndrome in infants with cystic periventricular leukomalacia. Epilepsia. 2003 Mar;44(3):443-6. doi: 10.1046/j.1528-1157.2003.29202.x.
Philippi H, Wohlrab G, Bettendorf U, Borusiak P, Kluger G, Strobl K, Bast T. Electroencephalographic evolution of hypsarrhythmia: toward an early treatment option. Epilepsia. 2008 Nov;49(11):1859-64. doi: 10.1111/j.1528-1167.2008.01715.x. Epub 2008 Jul 9.
Watanabe K, Iwase K, Hara K. The evolution of EEG features in infantile spasms: a prospective study. Dev Med Child Neurol. 1973 Oct;15(5):584-96. doi: 10.1111/j.1469-8749.1973.tb05169.x. No abstract available.
Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10. doi: 10.1016/0197-2456(89)90015-9.
Related Links
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Lurie Children's Epilepsy Center
Other Identifiers
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2011-14518
Identifier Type: -
Identifier Source: org_study_id
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