Post-Traumatic Seizure DisorderPhase 3NCT00004817
Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
A Phase 3 study testing phenytoin and valproate sodium in people with Post-Traumatic Seizure Disorder and Head Injuries, run by National Institute of Neurological Disorders and Stroke (NINDS).
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Post-Traumatic Seizure Disorder, Head Injuries
- What is being tested?
- phenytoin and valproate sodium
- How many people
- 385 participants
- Where
- No sites listed yet
- Study dates
- Feb 1991to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
About this study
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.
Read the 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.
- Conditions
- Post-Traumatic Seizure Disorder, Head Injuries
- Being tested
- phenytoin, valproate sodium
- Keywords
- neurologic and psychiatric disorders, rare disease, seizures
- Medical subject headings
- Epilepsy, Post-Traumatic, Craniocerebral Trauma, Neurologic Manifestations, Mental Disorders, Rare Diseases, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenytoinDrug
valproate sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2000 (estimated)
- Study startFeb 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Seizure DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Enrolment
- 385 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Harborview Injury Prevention and Research Center
- Investigators
- H. Richard Winn, Study chair, Harborview Injury Prevention and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004817
- Sponsor's protocol ID
- 199/12249
- Other IDs
- UW-19643
- Status last verified
- Dec 2001
- First submitted
- 24 Feb 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures
- ClinicalTrials.gov ID
- NCT00004817
- Acronym / sponsor ID
- 199/12249
- Conditions
- Post-Traumatic Seizure Disorder, Head Injuries
- Keywords
- neurologic and psychiatric disorders, rare disease, seizures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Collaborators
- Harborview Injury Prevention and Research Center
- Study start
- Feb 1991
- First posted
- 25 Feb 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenytoin | Drug | – |
| valproate sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
H. Richard Winn study chair
Harborview Injury Prevention and Research Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing phenytoin and valproate sodium in people with Post-Traumatic Seizure Disorder and Head Injuries, run by National Institute of Neurological Disorders and Stroke (NINDS).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.