Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?
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|ClinicalTrials.gov Identifier: NCT03054285|
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Seizures Traumatic Brain Injury||Drug: Levetiracetam||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The intervention study model is a randomized block design using a 1:1 allocation scheme|
|Masking:||None (Open Label)|
|Official Title:||Does Short-Term Anti-Seizure Prophylaxis After Traumatic Brain Injury Decrease Seizure Rates?|
|Actual Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||April 1, 2021|
No Intervention: No seizure prophylaxis
Participants randomized to this arm will not receive anti-seizure prophylaxis
Experimental: Seizure Prophylaxis
Participants randomized to this arm will receive the anti-seizure prophylaxis drug Levetiracetam for seven days post traumatic brain injury.
Participants assigned to the experimental arm will receive a seven day course of levetiracetam for post-traumatic brain injury
Other Name: Keppra
- Seizures (count of seizures) [ Time Frame: 30 days ]For all patients, the count of seizures will be recorded and compared between the two arms
- Mortality [ Time Frame: 30 days ]For all patients, days from head injury to death or last follow-up will be recorded and compared between the two arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054285
|Contact: Richard P Gonzalez, MDfirstname.lastname@example.org|
|Contact: Michael Anstadt, MDemail@example.com|
|Principal Investigator:||Richard Gonzalez, MD||Loyola University|