Biperiden Trial for Epilepsy Prevention
Recruiting
Phase 3
Interventional Study
Brain Injury Traumatic Moderate
Brain Injury Traumatic Severe
Post Traumatic Epilepsy
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 312 (estimated)
- Sponsor
- Hospital Sirio-Libanes · Other
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About This Trial
One of the most important neurological consequences following Traumatic Brain Injury (TBI) is the development of post traumatic epilepsy (PTE). Nevertheless, there is still no effective therapeutic intervention to reduce the occurrence of PTE. In previous studies with animals models of epilepsy, the biperiden decreased the incidence and intensity of spontaneous epileptic seizures besides delaying …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Given informed consent
* 18 - 75 years of age
* GCS between 6 and 12 at hospital admission. GCS between 3 and 5 at hospital admission can be enrolled if patient was sedated at the accident scene with previous GCS between 6 and 15.
* Moderate or severe acute traumatic brain inj…
Contacts