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

Primary Purpose

Post-Traumatic Seizure Disorder, Head Injuries

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
phenytoin
valproate sodium
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Seizure Disorder focused on measuring neurologic and psychiatric disorders, rare disease, seizures

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
    Collaborators
    Harborview Injury Prevention and Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004817
    Brief Title
    Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1991 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
    Collaborators
    Harborview Injury Prevention and Research Center

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Traumatic Seizure Disorder, Head Injuries
    Keywords
    neurologic and psychiatric disorders, rare disease, seizures

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Enrollment
    385 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    phenytoin
    Intervention Type
    Drug
    Intervention Name(s)
    valproate sodium

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    H. Richard Winn
    Organizational Affiliation
    Harborview Injury Prevention and Research Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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