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Clinical trial

Biperiden for Prevention of Epilepsy in Patients With Traumatic Brain Injury

ID
Name
AVAP-NG 1983
Description
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.
Trial arms
Trial start
2023-01-10
Estimated PCD
2026-12-20
Trial end
2026-12-20
Status
Recruiting
Phase
Early phase I
Treatment
Biperiden
5mg of biperiden diluted in 100 ml of 0.9% saline - every 6 hours for 10 consecutive days - IV
Arms:
Biperiden
Other names:
Akineton
Placebo
1ml sterile vehicle (sodium lactate, lactic acid, sodium hydroxide and water for injections) diluted in 100 ml 0.9% saline - every 6 hours for 10 consecutive days - IV
Arms:
Placebo
Other names:
Sterile vehicle (sodium lactate, lactic acid, sodium hydroxide and water for injections)
Size
312
Primary endpoint
Incidence of Post Traumatic Epilepsy (PTE)
7 days to 24 months
Occurrence of Severe Adverse Events
24 months
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 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, Exclusion Criteria: * Previous use of biperiden * History of epilepsy (confirmed by patient chart) * History of seizures or use of antiepileptic medication * Pregnancy * Participation in another clinical trial at the time of randomization * History of neoplasia, neurodegenerative diseases; history of stroke, cognitive impairment, benign prostatic hyperplasia, atrioventricular block or any other cardiac arrhythmia, or glaucoma megacolon or mechanical obstruction * Homeless patient
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 312, 'type': 'ESTIMATED'}}
Updated at
2024-03-26

1 organization

1 product

2 indications

Organization
Hospital Sirio-Libanes
Product
Biperiden
Indication
Traumatic Brain Injury
Indication
post-traumatic epilepsy