Health TrialsbyHealthPanel

Biperiden Trial for Epilepsy Prevention

ConditionsBrain Injury Traumatic ModerateBrain Injury Traumatic SeverePost Traumatic Epilepsy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHospital Sirio-Libanes

About this trial

One of the most important neurological consequences following Traumatic Brain Injury (TBI) is the development of post traumatic epilepsy (PTE). Nevertheless, there is still no effective therapeutic intervention to reduce the occurrence of PTE. In previous studies with animals models of epilepsy, the biperiden decreased the incidence and intensity of spontaneous epileptic seizures besides delaying their appearance. The aim of this study is the evaluation of biperiden as antiepileptogenic drug to prevent PTE and also the determination of side effects, evaluating its cost-effectiveness in patients with moderate and severe TBI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Given informed consent

18 - 75 years of age

GCS between 6 and 12 at hospital admission. GCS between 3 and 5 at hospital admission can be enrolled if patient was sedated at the accident scene with previous GCS between 6 and 15.

Moderate or severe acute traumatic brain injury

Disqualifiers

Previous use of biperiden

History of epilepsy (confirmed by patient chart)

History of seizures or use of antiepileptic medication

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biperiden

    Drug

    5mg of biperiden diluted in 100 ml of 0.9% saline - every 6 hours for 10 consecutive days - IV

  • Placebo

    Other intervention

    1ml sterile vehicle (sodium lactate, lactic acid, sodium hydroxide and water for injections) diluted in 100 ml 0.9% saline - every 6 hours for 10 consecutive days - IV

Treatment groups

312 Participants
are divided into 2 treatment groups
Group A: BiperidenExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Post Traumatic Epilepsy (PTE)

Participants who present epileptic seizures will be compared between placebo and biperiden groups. Seizures will be counted starting 7 days after TBI and continuously during the following two years follow-up period. Patients and their relatives will be asked to keep a diary of seizures, and record all seizures with detailed descriptions of each event.

Time frame
7 days to 24 months
2

Occurrence of Severe Adverse Events

Proportion of participants that present at least one severe adverse event until 24 months after the traumatic brain injury will be compared between biperiden and placebo groups.

Time frame
24 months

Secondary outcomes

1

Electroencephalogram Analyses: Presence of Epileptiform Discharges

Electroencephalogram (EEG) will be analysed mostly looking for epileptiform abnormalities and ictal patterns. EEG is going to be recorded at follow-up visits. Data will be compared between placebo and biperiden groups.

Time frame
1,3, 6, 9,12,18 and 24 months
2

Neuropsychological Assessments - semantic memory

Standard neuropsychologic test (Vocabulary) of the Wechsler Intelligence Scale III (WAIS III) which will be applied by psychologists at 6 months and then 24 months after TBI. It evaluate the semantic memory. It will be used the percentile scale that varies between 0.1 minimum (worst result) and 99.9 maximum (best result). The results will be compared between biperiden and placebo groups.

Time frame
6 and 24 months
3

Neuropsychological Assessments - visual construction

Standard neuropsychologic test (Block design) of the Wechsler Intelligence Scale III (WAIS III) which will be applied by psychologists at 6 months and then 24 months after TBI. It evaluates the visual construction. It will be used the percentile scale that varies between 0.1 minimum (worst result) and 99.9 maximum (best result). The results will be compared between biperiden and placebo groups.

Time frame
6 and 24 months
4

Neuropsychological Assessments - information processing speed and attention

Standard neuropsychologic test (Digit Symbol-Coding and Symbol Search) of the Wechsler Intelligence Scale III (WAIS III) which will be applied by psychologists at 6 months and then 24 months after TBI. It evaluates the information processing speed and attention. It will be used the percentile scale that varies between 0.1 minimum (worst result) and 99.9 maximum (best result). The results will be compared between biperiden and placebo groups.

Time frame
6 and 24 months

Other outcomes

1

Incidence of Mortality

Participants who died throughout the period of study (24 months after TBI) will be compared between placebo and biperiden groups. Although patients includes are severe, the effectiveness of biperiden to reduce mortality might be evaluated,

Time frame
24 months
2

Incidence of Non-Severe Adverse Events

Biperiden and placebo groups will be compared for occurrence of any non-severe adverse events at each visit of follow-up, from 1 month to 24 months.

Time frame
1,3, 6, 9,12,18 and 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Sirio-Libanes

Lead sponsor

PROADI-SUS

Collaborator

Ministry of Health, Brazil

Collaborator

University of Sao Paulo

Collaborator

Santa Casa de Campo Grande

Collaborator

Hospital Sao Rafael

Collaborator

Santa Casa de Misericórdia de Sobral

Collaborator

Hospital São Paulo, Universidade Federal de São Paulo

Collaborator

Instituto Doutor José Frota

Collaborator

Hospital São Vicente de Paulo

Collaborator

Source ClinicalTrials.gov
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