- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004817
Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: H. Richard Winn, Harborview Injury Prevention and Research Center
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Trauma, Nervous System
- Brain Injuries
- Epilepsy
- Seizures
- Craniocerebral Trauma
- Epilepsy, Post-Traumatic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Tranquilizing Agents
- Psychotropic Drugs
- Membrane Transport Modulators
- GABA Agents
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Antimanic Agents
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Valproic Acid
- Phenytoin
Other Study ID Numbers
- 199/12249
- UW-19643
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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