Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures

NCT00004817 | Completed Phase 3

• 2 other identifiers: 199/12249UW-19643
• Study Type: interventional
• Target: 385
• Locations: 0 countries
• Sites: N/A

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 brain's ability to compute numbers, solve problems, remember information, and control the movement of limbs after head injury.

Conditions

Post-Traumatic Seizure Disorder; Head Injuries

Keywords

neurologic and psychiatric disorders; rare disease; seizures

Interventions

phenytoin DRUG

valproate sodium DRUG

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Any patient developing the following conditions within 24 hour postinjury: * Cortical contusion * Depressed skull fracture * Subdural hematoma * Epidural hematoma * Intracerebral hematoma * Penetrating head wound * Seizures occurring subsequent to head injury --Prior/Concurrent Therapy-- * No antiseizure medication prior to injury or between the injury and study drug loading * Surgery: No prior neurosurgical operation for which the skull and dura mater were opened --Patient Characteristics-- * Age: 14 and over * Hematopoietic: No abnormal coagulation profile * Hepatic: No history of chronic or alcoholic liver disease Adequate liver function as indicated by ALT less than 1.5 times the upper limit of normal * Other: Not pregnant No injuries greater than 24 hours old No history of seizures prior to injury No prior history of significant head injury or neurological condition requiring medical attention

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead
• Harborview Injury Prevention and Research Center: collaborator

MeSH Terms

Conditions

Epilepsy, Post-Traumatic; Craniocerebral Trauma; Neurologic Manifestations; Mental Disorders; Rare Diseases; Seizures

Interventions

Phenytoin; Valproic Acid

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• H. Richard Winn

  Harborview Injury Prevention and Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 24, 2000
• First Posted: February 25, 2000
• Study Start: February 1, 1991
• Last Updated: June 24, 2005

Record last verified: 2001-12