Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004758
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-9508342 | None | None | None |