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

This study has been completed.
Sponsor:
Collaborator:
Harborview Injury Prevention and Research Center
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004817
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: December 2001
  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 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 385
Study Start Date: February 1991
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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004817

Sponsors and Collaborators
Harborview Injury Prevention and Research Center
Investigators
Study Chair: H. Richard Winn Harborview Injury Prevention and Research Center
  More Information

No publications provided

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

Keywords provided by Office of Rare Diseases (ORD):
neurologic and psychiatric disorders
rare disease
seizures

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Post-Traumatic
Seizures
Brain Diseases
Brain Injuries
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries
Valproic Acid
Anticonvulsants
Antimanic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014