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| Sponsor: | National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Collaborator: |
Harborview Injury Prevention and Research Center |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004817 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Traumatic Seizure Disorder Head Injuries |
Drug: phenytoin Drug: valproate sodium |
Phase III |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Estimated Enrollment: | 385 |
| Study Start Date: | February 1991 |
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.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Any patient developing the following conditions within 24 hour postinjury:
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00004817 History of Changes |
| Other Study ID Numbers: | 199/12249, UW-19643 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
|
neurologic and psychiatric disorders rare disease seizures |
|
Epilepsy Epilepsy, Post-Traumatic Craniocerebral Trauma Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Brain Injuries Trauma, Nervous System Wounds and Injuries Neurologic Manifestations Signs and Symptoms Phenytoin Valproic Acid |
Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
