Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury

Who is this study for? Patients with traumatic brain injury
What treatments are being studied? Biperiden
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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 their appearance. The aim of this study is the evaluation of biperiden as antiepileptogenic drug to prevent PTE and also the determination of side effects, evaluating its cost-effectiveness in patients with moderate and severe TBI.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 injury

• All genders

• Brain CT scan with signs of of acute intraparenchymal hemorrhage and/or contusion

• Able to receive the first dose of treatment or placebo within 18 hours of brain injury,

Locations
Other Locations
Brazil
Associação Beneficente Santa Casa de Campo Grande
RECRUITING
Campo Grande
Instituto Doutor José Frota
NOT_YET_RECRUITING
Fortaleza
Hospital São Vicente de Paulo
ACTIVE_NOT_RECRUITING
Passo Fundo
Hospital das Clínicas da Faculdade de Medicina da Universidade de Ribeirão Preto
RECRUITING
Ribeirão Preto
Hospital São Rafael
RECRUITING
Salvador
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
RECRUITING
São Paulo
Hospital São Paulo, Universidade Federal de São Paulo
NOT_YET_RECRUITING
São Paulo
Hospital Sirio-Libanes
RECRUITING
São Paulo
Santa Casa de Misericórdia de Sobral
RECRUITING
Sobral
Hospital Estadual Urgencia e Emergencia -HEUE
NOT_YET_RECRUITING
Vitória
Contact Information
Primary
Eliana Garzon, MD, PhD
eliana.garzon@hsl.org.br
+55 (11) 98206-2308
Backup
Maira L Foresti, PhD
mairalforesti@gmail.com
+ 55(11) 958673803
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 312
Treatments
Experimental: Biperiden
Drug: Biperiden 5mg of biperiden diluted in 100 ml of 0.9% saline - every 6 hours for 10 consecutive days - IV
Placebo_comparator: Placebo
Placebo~1 mL of sterile vehicle (sodium lactate, lactic acid, sodium hydroxide and water for injections) diluted in 100 mL of 0,9% saline - every 6 hours for 10 consecutive days - IV
Sponsors
Collaborators: Santa Casa de Campo Grande, Hospital São Vicente de Paulo, Instituto Doutor José Frota, University of Sao Paulo, Hospital São Paulo, Universidade Federal de São Paulo, Hospital de Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Santa Casa de Misericórdia de Sobral, Ministry of Health, Brazil, Hospital Sao Rafael, PROADI-SUS
Leads: Hospital Sirio-Libanes

This content was sourced from clinicaltrials.gov

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