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CompletedNCT00004758Updated Jun 24, 2005

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

A Phase 2 interventional study of carbamazepine and corticotropin in Spasms, Infantile and Epilepsy, sponsored by National Center for Research Resources (NCRR). Completed. Open to participants aged 0 Years to 2 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by National Center for Research Resources (NCRR) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
0 Years to 2 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Spasms, Infantile
  • Epilepsy

Keywords

  • infantile spasms
  • epilepsy
  • neurologic and psychiatric disorders
  • rare disease
  • seizures
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

National Center for Research Resources (NCRR) is the lead sponsor of 265 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 2 Years
Sexes eligible
All
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Enrollment
30 participants

Interventions

  • Drugcarbamazepine
  • Drugcorticotropin
  • Drugnitrazepam
  • Drugpyridoxine
  • Drugvalproic acid
  • ProcedureSurgery
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004758
Lead sponsor
National Center for Research Resources (NCRR)
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), University of California, Los Angeles
First posted
Feb 25, 2000
Start date
Nov 1993
Last update
Jun 24, 2005

Study contacts

W. Donald Shields
study chair · University of California, Los Angeles
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2001. You cannot join it, but the record below documents what was studied.

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