Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study

CEP0560/05

There is no AED or medication that has been demonstrated to affect the development of post-traumatic epilepsy. Biperiden is a cholinergic antagonist, acting in the muscarinic receptor, that is widely used as an anti Parkinson drug. The investigators data with animal models of epilepsy indicate that anti-muscarinic agents might affect the natural course of the disease in the case of post-traumatic epilepsy.

2018-01-31

2022-12-02

2022-12-02

Terminated

Early phase I

123

Inclusion Criteria: * between 18 and 75 year of age * patients with a diagnosis of acute TBI admitted to an emergency unit within 12 hours of the accident, regardless of the accident * brain CT scan with signs of acute intraparenchymatous contusion * signed informed consent (possibly by a relative) Exclusion Criteria: * malignant neoplasia and other severe comorbidities * neurodegenerative disorders * previous cerebrovascular accident * record of convulsive seizures or use of anti-epileptic medication * pregnancy * concomitant use of the other anticholinergic medications * presence of any factor that may contraindicate the use of biperiden * participation in other clinical trial * alcohol intoxication will not lead to exclusion of the subject.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 123, 'type': 'ACTUAL'}}

2023-01-31