|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) National Institute of Neurological Disorders and Stroke (NINDS) University of California, Los Angeles |
|---|---|
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004758 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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
Prior/Concurrent Therapy
Patient Characteristics
Contacts and Locations More Information
| Study ID Numbers: | 199/11691, UCLA-9508342 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004758 History of Changes |
| Health Authority: | United States: Federal Government |
|
infantile spasms epilepsy neurologic and psychiatric disorders rare disease seizures |
|
Spasm Neurotransmitter Agents Spasms, Infantile Hormone Antagonists Psychotropic Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Brain Diseases Valproic Acid Hormones Vitamin B 6 Adrenocorticotropic Hormone Signs and Symptoms West Syndrome Mental Disorders Pyridoxal |
Vitamins Hypnotics and Sedatives Micronutrients Analgesics Infantile Spasms Vitamin B Complex Tranquilizing Agents Seizures Nitrazepam Rare Diseases Central Nervous System Depressants Central Nervous System Diseases Trace Elements Antimanic Agents Carbamazepine |
|
Spasm Neurotransmitter Agents Spasms, Infantile Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Brain Diseases Valproic Acid Hormones Adrenocorticotropic Hormone Signs and Symptoms Sensory System Agents Vitamins |
Therapeutic Uses Hypnotics and Sedatives Micronutrients Analgesics Neuromuscular Manifestations Vitamin B Complex Tranquilizing Agents Growth Substances Nervous System Diseases Nitrazepam Central Nervous System Diseases Central Nervous System Depressants Enzyme Inhibitors Antimanic Agents Pharmacologic Actions |
