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Use of Biperiden for the Prevention of Post-traumatic Epilepsy

Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Traumatic Brain Injury

Intervention: Biperiden Lactate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Federal University of São Paulo

Official(s) and/or principal investigator(s):
Rafael Loduca, 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 epilepsy

Quality 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: March 2014
Last updated: April 15, 2014

Page last updated: November 27, 2014

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