Use of Biperiden for the Prevention of Post-traumatic Epilepsy

NCT01048138 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2023-01-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Biperiden Lactate

5mg IV(in the vein)every 6 hours for 10 days

DRUG

Placebo

5mg IV(in the vein)every 6 hours for 10 days

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER
  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Luiz Mello · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2022-12-02
Completion
2022-12-02

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01048138 on ClinicalTrials.gov