Use of Biperiden for the Prevention of Post-traumatic Epilepsy
Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury
Intervention: Biperiden (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s):
Julieta G Silva, Principal Investigator, Affiliation: Federal University of São Paulo
Overall contact:
Luiz Mello, Phone: 5511-55792033, Email: lemello@unifesp.br
Summary
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.
Clinical Details
Official title: Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Onset of post-traumatic epilepsy
Secondary outcome: Onset of post-traumatic epilepsyQuality of Life Cognitive level
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- between 18 and 75 year of age
- patients with a diagnosis of severe TBI admitted to an emergency unit within 6 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
- cerebrovascular accident in the previous 6 months
- 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.
Locations and Contacts
Luiz Mello, Phone: 5511-55792033, Email: lemello@unifesp.br
Federal University of São Paulo, Sao Paulo, Brazil; Recruiting
Luiz EM Mello, Phone: 55-11-55792033, Email: lemello@unifesp.br
Luiz EM Mello, Principal Investigator
Additional Information
Starting date: May 2010
Last updated: January 15, 2010
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