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Use of Biperiden for the Prevention of Post-traumatic Epilepsy

This study is currently recruiting participants.
Verified July 2017 by Luiz Eugenio Mello, Federal University of São Paulo
Sponsor:
ClinicalTrials.gov Identifier:
NCT01048138
First Posted: January 13, 2010
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by (Responsible Party):
Luiz Eugenio Mello, Federal University of São Paulo
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by Luiz Eugenio Mello, Federal University of São Paulo:

Primary Outcome Measures:
  • Onset of post-traumatic epilepsy [ Time Frame: 12 months after hospital discharge ]
    Clinical exam,EEG,CT scan


Secondary Outcome Measures:
  • Onset of post-traumatic epilepsy [ Time Frame: 24 months after hospital discharge ]
    Clinical exam,EEG,CT scan

  • Quality of Life [ Time Frame: Measured at 12 and 24 month after hospital discharge ]
    QOLIBRI (Quality of Life After Brain Injury)

  • Cognitive level [ Time Frame: Measured at 12 and 24 month after hospital discharge ]
    Wechsler Memory Scale - Revised


Estimated Enrollment: 132
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: August 2018 (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
5mg IV(in the vein)every 6 hours for 10 days
Other Names:
  • akineton
  • cinetol
Placebo Comparator: Placebo
5mg IV(in the vein)every 6 hours for 10 days
Drug: Placebo
5mg IV(in the vein)every 6 hours for 10 days
Other Name: saline solution

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048138


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

Locations
Brazil
Federal University of São Paulo 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

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
First Submitted: January 12, 2010
First Posted: January 13, 2010
Last Update Posted: August 1, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

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