Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004817
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
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 Determine whether treating head injured patients with valproate sodium will reduce the risk of developing seizures as a result of the head injury
II Determine the safety of valproate the appropriate dose and the effect valproate may have on the recovery of the brains ability to compute numbers solve problems remember information and control the movement of limbs after head injury
II Determine the safety of valproate the appropriate dose and the effect valproate may have on the recovery of the brains ability to compute numbers solve problems remember information and control the movement of limbs after head injury
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind trial involving 3 treatment groups
On day 1 controls receive phenytoin IV over 1 hour On days 2 through 7 controls receive 2 doses each of phenytoin and placebo daily intravenously From day 8 through 6 months controls receive placebo IV 4 times daily then placebo tablets are administered
On day 1 the experimental group receives a loading dose of valproate sodium intravenously over 1 hour within 24 hours of injury Then patients are divided into 2 subgroups
From day 2 through 1 month one group of patients receives valproate IV 4 times daily over 1 hour until tablets are tolerated Patients receive placebo tablets by mouth 4 times daily from month 2 through month 6
On day 2 the other group of patients receives valproate IV 4 times daily and continues for 6 months until tablets same dose are tolerated
If patients remain seizure free between day 8 and 6 months the number of valproate or placebo tablets are tapered over 1 week
Each patient receives a full neuropsychological and psychosocial examination at 1 6 and 12 months after injury
Untreated observation of patients continues until 2 years after injury
On day 1 controls receive phenytoin IV over 1 hour On days 2 through 7 controls receive 2 doses each of phenytoin and placebo daily intravenously From day 8 through 6 months controls receive placebo IV 4 times daily then placebo tablets are administered
On day 1 the experimental group receives a loading dose of valproate sodium intravenously over 1 hour within 24 hours of injury Then patients are divided into 2 subgroups
From day 2 through 1 month one group of patients receives valproate IV 4 times daily over 1 hour until tablets are tolerated Patients receive placebo tablets by mouth 4 times daily from month 2 through month 6
On day 2 the other group of patients receives valproate IV 4 times daily and continues for 6 months until tablets same dose are tolerated
If patients remain seizure free between day 8 and 6 months the number of valproate or placebo tablets are tapered over 1 week
Each patient receives a full neuropsychological and psychosocial examination at 1 6 and 12 months after injury
Untreated observation of patients continues until 2 years after injury
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 |
|---|---|---|---|
| UW-19643 | None | None | None |