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Use of Biperiden for the Prevention of Post-traumatic Epilepsy

This study is not yet open for participant recruitment.
Verified May 2013 by Federal University of São Paulo
Sponsor:
Collaborator:
Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by (Responsible Party):
Luiz Eugenio Mello, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01048138
First received: January 12, 2010
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
 Drug: Biperiden Lactate
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Onset of post-traumatic epilepsy [ Time Frame: 12 months after hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Onset of post-traumatic epilepsy [ Time Frame: 24 months after hospital discharge ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Measured at 12 and 24 month after hospital discharge ] [ Designated as safety issue: No ]
  • Cognitive level [ Time Frame: Measured at 12 and 24 month after hospital discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: June 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biperiden Lactate
5mg IV(in the vein)every 6 hours for 10 days
 Drug: Biperiden Lactate
Placebo Comparator: Placebo
5mg IV(in the vein)every 6 hours for 10 days
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048138

Contacts
Contact: Luiz Mello 5511-55792033 lemello@unifesp.br

Locations
Brazil
Federal University of São Paulo Not yet recruiting
Sao Paulo, Brazil
Contact: Luiz EM Mello     55-11-55792033     lemello@unifesp.br    
Principal Investigator: Luiz EM Mello            
Sponsors and Collaborators
Federal University of São Paulo
Cristália Produtos Químicos Farmacêuticos Ltda.
Investigators
Principal Investigator: Rafael Loduca Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Luiz Eugenio Mello, M.D.Ph.D., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01048138     History of Changes
Other Study ID Numbers: CEP0560/05
Study First Received: January 12, 2010
Last Updated: May 16, 2013
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
Biperiden
Post-traumatic Epilepsy
Traumatic Brain Injury

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Post-Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Biperiden
Parasympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013