drugset / Trial / NCT00004758
Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment
Phase 2
Completed
30 enrolled
National Center for Research Resources (NCRR)
National Institute of Neurological Disorders and Stroke (NINDS) · collabUniversity of California, Los Angeles · collab
RandomizedTreatment
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.
Timeline
- Start
- 1993-11
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acthar | Peptide | — | — |
| Subject | Carbamazepine | Small molecule | — | — |
| Subject | Pyridoxine | Unknown | — | — |
| Subject | Valproic Acid | Small molecule | — | — |
| Subject | nitrazepam | Small molecule | — | — |