|
Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures Clinical research trials and Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures. Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures clinical trial. Subjects typically recieve the finest healthcare available for their Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures  Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
For Condition: Head Injuries,Post-Traumatic Seizure Disorder
Status: Completed
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) , Harborview Medical Center
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 14 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 385
Location and Contact Information:
Overall Study Official:
H.Winn, Study Chair, Harborview Medical Center
Additional Information:
Study ID Numbers: 199/12249; UW-19643
Study Start Date: February 1991
Record last reviewed: December 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004817
Other Head Injuries Studies:
1. Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
Related Studies:
Other Head Injuries Clinical Trials
Other Clinical Trials
Other Clinical Trials
Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
|
|
|
|
|
|
|
|
