Use of Biperiden for the Prevention of Post-traumatic Epilepsy

NCT01048138 | Terminated Phase 3 DMC

• 1 other identifier: CEP0560/05
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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

Traumatic Brain Injury

Keywords

Biperiden; Post-traumatic Epilepsy; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Clinical Outcome: Indidence of post-traumatic epilepsy

  The incidence of seizures will be evaluated starting immediately after TBI and continuously during the hospitalization period and after hospital discharge during the two year follow up period. Patients and their relatives will be asked to maintain a diary of seizures, and thus record all seizures with detailed descriptions of each event. The recordings will be evaluated in each patient visit. Seizures incidence will be compared between placebo and biperiden-treated patients.

  24 months after TBI

Secondary Outcomes (2)

• Frequency of seizures

  24 months after TBI

• Mortality and adverse effects

  24 months after TBI

Other Outcomes (8)

• Electroencephalogram Analysis: Presence of Epileptiform Discharges

  during first 10 days after TBI and 1, 3, 6, 9, 12, 18 and 24 months after TBI

• Cognitive Assessments - Wechsler Adult Intelligence Scale (WAIS) - III

  6, 12 and 24 months after hospital discharge

• Quality of Life assessments - European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L), EQ-VAS

  24 month after TBI

Study Arms (2)

Biperiden Lactate

EXPERIMENTAL

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

Drug: Biperiden Lactate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Biperiden Lactate DRUG

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

Also known as: akineton, cinetol

Biperiden Lactate

Placebo DRUG

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

Also known as: saline solution

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 and 75 year of age
• patients with a diagnosis of acute TBI admitted to an emergency unit within 12 hours of the accident, regardless of the accident
• brain CT scan with signs of acute intraparenchymatous contusion
• signed informed consent (possibly by a relative)

You may not qualify if:

• malignant neoplasia and other severe comorbidities
• neurodegenerative disorders
• previous cerebrovascular accident
• 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

Sponsors & Collaborators

• Federal University of São Paulo: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Federal University of São Paulo

São Paulo, Brazil

Location

Related Publications (1)

• Foresti ML, Garzon E, de Moraes MT, Valeriano RPS, Santiago JP, Dos Santos GM, Longo NM, Baise C, Andrade JCQF, Susemihl MA, Leite CDC, Naffah Mazzacoratti MDG, Paiva WS, de Andrade AF, Teixeira MJ, Mello LE. Initial clinical evidence on biperiden as antiepileptogenic after traumatic brain injury-a randomized clinical trial. Front Neurol. 2024 Aug 7;15:1443982. doi: 10.3389/fneur.2024.1443982. eCollection 2024.

  PMID: 39175759 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Epilepsy, Post-Traumatic

Interventions

biperiden lactate; Biperiden; Saline Solution

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Epilepsy

Intervention Hierarchy (Ancestors)

Bridged Bicyclo Compounds; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azabicyclo Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Luiz Mello

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: January 31, 2018
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

BR (1)