NCT01367964

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 16, 2018

Status Verified

November 1, 2018

Enrollment Period

7.4 years

First QC Date

June 3, 2011

Last Update Submit

November 14, 2018

Conditions

West Syndrome

Keywords

HypsarrhythmiaSpasms, InfantileWest Syndrome

Outcome Measures

Primary Outcomes (1)

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

    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).

    1 month

Study Arms (1)

ACTH treatment

EXPERIMENTAL

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

Drug: adrenocorticotropin hormone

Interventions

adrenocorticotropin hormoneDRUG

ACTH 16 units intramuscular injection once daily for 2 weeks

Also known as: H.P. Acthar® Gel (repository corticotropin injection)
ACTH treatment

Eligibility Criteria

Age2 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (6)

  • 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.

    PMID: 13532578BACKGROUND

  • 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.

    PMID: 11701242BACKGROUND

  • 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.

    PMID: 12614401BACKGROUND

  • 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.

    PMID: 18631366BACKGROUND

  • 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.

    PMID: 4358106BACKGROUND

  • 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.

    PMID: 2702835BACKGROUND

Related Links

MeSH Terms

Conditions

Spasms, Infantile

Condition Hierarchy (Ancestors)

Epilepsy, GeneralizedEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician, Division of Neurology

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 7, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 16, 2018

Record last verified: 2018-11

Locations

US(1)