Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Spasms, Infantile Epilepsy |
Drug: carbamazepine Drug: corticotropin Drug: nitrazepam Drug: pyridoxine Drug: valproic acid Procedure: Surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Estimated Enrollment: | 30 |
| Study Start Date: | November 1993 |
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.
Eligibility| Ages Eligible for Study: | up to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004758 History of Changes |
| Other Study ID Numbers: | 199/11691, UCLA-9508342 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Office of Rare Diseases (ORD):
|
infantile spasms epilepsy neurologic and psychiatric disorders rare disease seizures |
Additional relevant MeSH terms:
|
Epilepsy Spasm Spasms, Infantile Brain Diseases Central Nervous System Diseases Nervous System Diseases Neuromuscular Manifestations Neurologic Manifestations Signs and Symptoms Epilepsy, Generalized Adrenocorticotropic Hormone Anticonvulsants Valproic Acid Carbamazepine Nitrazepam |
Pyridoxine Vitamin B 6 Pyridoxal Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Antimanic Agents Tranquilizing Agents |
ClinicalTrials.gov processed this record on June 17, 2013