Valproate de sodium pour la prophylaxie des crises d'épilepsie post-traumatiques
phenytoin
+ valproate sodium
Maladies du cerveau+14
+ Traumatismes crâniens
+ Maladies du système nerveux central
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 1991
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.385 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 14 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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