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Use of Biperiden for the Prevention of Post-traumatic Epilepsy

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ClinicalTrials.gov Identifier: NCT01048138
Recruitment Status : Recruiting
First Posted : January 13, 2010
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

January 12, 2010
January 13, 2010
August 1, 2017
August 2017
August 2018   (Final data collection date for primary outcome measure)
Onset of post-traumatic epilepsy [ Time Frame: 12 months after hospital discharge ]
Clinical exam,EEG,CT scan
Onset of post-traumatic epilepsy [ Time Frame: 12 months after hospital discharge ]
Complete list of historical versions of study NCT01048138 on ClinicalTrials.gov Archive Site
  • 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
  • Onset of post-traumatic epilepsy [ Time Frame: 24 months after hospital discharge ]
  • Quality of Life [ Time Frame: Measured at 12 and 24 month after hospital discharge ]
  • Cognitive level [ Time Frame: Measured at 12 and 24 month after hospital discharge ]
Not Provided
Not Provided
 
Use of Biperiden for the Prevention of Post-traumatic Epilepsy
Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Traumatic Brain Injury
  • Drug: Biperiden Lactate
    5mg IV(in the vein)every 6 hours for 10 days
    Other Names:
    • akineton
    • cinetol
  • Drug: Placebo
    5mg IV(in the vein)every 6 hours for 10 days
    Other Name: saline solution
  • Experimental: Biperiden Lactate
    5mg IV(in the vein)every 6 hours for 10 days
    Intervention: Drug: Biperiden Lactate
  • Placebo Comparator: Placebo
    5mg IV(in the vein)every 6 hours for 10 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
132
November 2019
August 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Luiz Mello 5511-55792033 lemello@unifesp.br
Brazil
 
 
NCT01048138
CEP0560/05
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Luiz Eugenio Mello, Federal University of São Paulo
Federal University of São Paulo
Cristália Produtos Químicos Farmacêuticos Ltda.
Principal Investigator: Rafael Loduca Federal University of São Paulo
Federal University of São Paulo
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP