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Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment

Primary Purpose

Spasms, Infantile, Epilepsy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
carbamazepine
corticotropin
nitrazepam
pyridoxine
valproic acid
Surgery
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasms, Infantile focused on measuring infantile spasms, epilepsy, neurologic and psychiatric disorders, rare disease, seizures

Eligibility Criteria

0 Years - 2 Years (Child)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: Disease Characteristics Infantile spasms or seizures with diagnosis based on the following: short muscular contractions leading to flexion or extension; Single or repetitive electroencephalogram (EEG) consistent with diagnosis, i.e., hypsarrhythmia, modified hypsarrhythmia, multifocal spike and wave abnormalities; developmental quotient less than 70 Zone of cortical abnormality in 1 lobe, contiguous multilobes, or 1 hemisphere; confirmed by historical, neurological, and physical evidence, including EEG, closed circuit televised EEG, computed tomography, magnetic resonance imaging, and/or positron-emission tomography; at least 2 abnormal test/imaging results required No treatable seizure etiology such as metabolic disease or infection Prior/Concurrent Therapy Failed standard therapy, i.e., refractory to corticotropin (at least 40 IU/day for 14 days) as follows: persistent infantile spasms OR recurrent spasms after discontinuation or taper OR complications requiring dose modification At least 1 month of standard antiepileptic drug with documented therapeutic blood levels Patient Characteristics No medical contraindication to surgery English-speaking family

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS), University of California, Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004758
    Brief Title
    Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1993 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    National Institute of Neurological Disorders and Stroke (NINDS), University of California, Los Angeles

    4. Oversight

    5. Study Description

    Brief Summary
    OBJECTIVES: I. Evaluate the efficacy of surgical resection of an identifiable zone of cortical abnormality versus multiple drug therapy in children with infantile spasms refractory to standard therapy. II. Assess how infantile spasms interfere with development and whether this is partially reversible. III. Determine the predictors of good surgical outcome and whether surgery permanently controls seizures and improves development.
    Detailed Description
    PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to 1 of 2 treatment groups. The first group undergoes sequential antiepileptic therapy with pyridoxine, corticotropin, valproic acid, carbamazepine, and nitrazepam. The sequence of administration may be altered based on drugs taken prior to entry. Any drug may be omitted due to medical contraindications or prior use at study doses or higher. The second group undergoes surgical resection of the zone of cortical abnormality. A functional hemispherectomy is performed for hemiparesis or diffuse unihemispheric dysfunction. If seizures are controlled in the first group at 3 months, the current medication is maintained; if seizures are not controlled, sequential therapy continues to completion. Patients experiencing uncontrolled seizures at 6 months cross to surgery. Surgical patients experiencing uncontrolled seizures at 3 months or persistent seizures after taper of pre-study antiepileptics cross to drug therapy. All patients are followed at 6 months and 1, 2, 3, 5, 7, and 10 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spasms, Infantile, Epilepsy
    Keywords
    infantile spasms, epilepsy, neurologic and psychiatric disorders, rare disease, seizures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Allocation
    Randomized
    Enrollment
    30 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    carbamazepine
    Intervention Type
    Drug
    Intervention Name(s)
    corticotropin
    Intervention Type
    Drug
    Intervention Name(s)
    nitrazepam
    Intervention Type
    Drug
    Intervention Name(s)
    pyridoxine
    Intervention Type
    Drug
    Intervention Name(s)
    valproic acid
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    2 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    PROTOCOL ENTRY CRITERIA: Disease Characteristics Infantile spasms or seizures with diagnosis based on the following: short muscular contractions leading to flexion or extension; Single or repetitive electroencephalogram (EEG) consistent with diagnosis, i.e., hypsarrhythmia, modified hypsarrhythmia, multifocal spike and wave abnormalities; developmental quotient less than 70 Zone of cortical abnormality in 1 lobe, contiguous multilobes, or 1 hemisphere; confirmed by historical, neurological, and physical evidence, including EEG, closed circuit televised EEG, computed tomography, magnetic resonance imaging, and/or positron-emission tomography; at least 2 abnormal test/imaging results required No treatable seizure etiology such as metabolic disease or infection Prior/Concurrent Therapy Failed standard therapy, i.e., refractory to corticotropin (at least 40 IU/day for 14 days) as follows: persistent infantile spasms OR recurrent spasms after discontinuation or taper OR complications requiring dose modification At least 1 month of standard antiepileptic drug with documented therapeutic blood levels Patient Characteristics No medical contraindication to surgery English-speaking family
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    W. Donald Shields
    Organizational Affiliation
    University of California, Los Angeles
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment

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