Traumatic Brain InjuryPhase 3NCT01048138
Use of Biperiden for the Prevention of Post-traumatic Epilepsy
A Phase 3 study testing Biperiden Lactate in people with Traumatic Brain Injury, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Biperiden Lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jan 2018to 2 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Treatment with biperiden should be initiated in the first 12 hours after trauma as means to avoid the epileptogenic process. The treatment will be repeated every 6 hours for 10 consecutive days. The efficacy of biperiden as an antiepileptogenic drug will be established by analyzing the development of PTE between the biperiden and placebo groups. Several patients' aspects (clinical, electroencephalography, brain imaging, genetic and behavioral data) will be monitored for two year follow-up to unravel the mechanisms by which biperiden exerts its actions on epileptogenesis. The investigators are already at the early stages of patient's recruitment using the available resources.
- Conditions
- Traumatic Brain Injury
- Being tested
- Biperiden Lactate, Placebo
- Keywords
- Biperiden, Post-traumatic Epilepsy, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic, Epilepsy, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biperiden LactateDrug
Also called akineton, cinetol
5mg IV(in the vein)every 6 hours for 10 days
PlaceboDrug
Also called saline solution
5mg IV(in the vein)every 6 hours for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Biperiden Lactate | Experimental | 5mg IV(in the vein)every 6 hours for 10 days Receives: Drug: Biperiden Lactate |
| Placebo | Placebo comparator | 5mg IV(in the vein)every 6 hours for 10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months after TBI
Secondary outcomes (2)
Frequency of seizures
The frequency of seizures will be counted starting immediately after TBI and continuously during the hospitalization period and after hospital discharge during the two year follow up period. Frequency of seizure will be compared between placebo and biperiden-treated patients.
Measured: 24 months after TBI
Mortality and adverse effects
The incidence of death and adverse effects will be counted starting immediately after TBI and continuously during the hospitalization period and after hospital discharge during the two year follow up period. Incidence of death and adverse effects will be compared between placebo and biperiden-treated patients.
Measured: 24 months after TBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study start31 Jan 2018
- Primary completion2 Dec 2022
- Study completion2 Dec 2022
Why it stopped: Recruitment and funding issues, together with the event of the SARS-CoV-2 pandemic prompted an adjustment in the study design to stop enrollment at 123 patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Luiz Eugenio Mello, Federal University of São Paulo
- Investigators
- Luiz Mello, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048138
- Sponsor's protocol ID
- CEP0560/05
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2010
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Romariz SAA, Marinelli BPT, Bergo MFC, Foresti ML, Mello LE. Evaluation of long-term quality of life in traumatic brain injury patients early treated with biperiden - a randomized controlled trial. BMC Neurol. 2026 Jun 1;26(1):411. doi: 10.1186/s12883-026-05029-7.
PubMed 42219462Foresti 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.
PubMed 39175759
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study
- ClinicalTrials.gov ID
- NCT01048138
- Acronym / sponsor ID
- CEP0560/05
- Conditions
- Traumatic Brain Injury
- Keywords
- Biperiden, Post-traumatic Epilepsy, Traumatic Brain Injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment and funding issues, together with the event of the SARS-CoV-2 pandemic prompted an adjustment in the study design to stop enrollment at 123 patients.
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment with biperiden should be initiated in the first 12 hours after trauma as means to avoid the epileptogenic process. The treatment will be repeated every 6 hours for 10 consecutive days. The efficacy of biperiden as an antiepileptogenic drug will be established by analyzing the development of PTE between the biperiden and placebo groups. Several patients' aspects (clinical, electroencephalography, brain imaging, genetic and behavioral data) will be monitored for two year follow-up to unravel the mechanisms by which biperiden exerts its actions on epileptogenesis. The investigators are already at the early stages of patient's recruitment using the available resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biperiden Lactate | Experimental | Drug: Biperiden Lactate5mg IV(in the vein)every 6 hours for 10 days |
| Placebo | Placebo comparator | Drug: Placebo5mg IV(in the vein)every 6 hours for 10 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- malignant neoplasia and other severe comorbidities
- neurodegenerative disorders
- previous cerebrovascular accident
- record of convulsive seizures or use of anti-epileptic medication
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biperiden LactateAlso: akineton, cinetol5mg IV(in the vein)every 6 hours for 10 days | Drug | Biperiden Lactate |
| PlaceboAlso: saline solution5mg IV(in the vein)every 6 hours for 10 days | Drug | Placebo |
Primary outcome
Clinical Outcome: Indidence of post-traumatic epilepsy
Time frame: 24 months after TBI
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.
2 secondary outcomes
Frequency of seizures
Time frame: 24 months after TBI
Mortality and adverse effects
Time frame: 24 months after TBI
Results and safety
The study was stopped early (reason given: Recruitment and funding issues, together with the event of the SARS-CoV-2 pandemic prompted an adjustment in the study design to stop enrollment at 123 patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 42219462Romariz SAA, Marinelli BPT, Bergo MFC, Foresti ML, Mello LE. Evaluation of long-term quality of life in traumatic brain injury patients early treated with biperiden - a randomized controlled trial. BMC Neurol. 2026 Jun 1;26(1):411. doi: 10.1186/s12883-026-05029-7.
- Derived from this study: PubMed 39175759Foresti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz Mello principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Biperiden Lactate in people with Traumatic Brain Injury, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment and funding issues, together with the event of the SARS-CoV-2 pandemic prompted an adjustment in the study design to stop enrollment at 123 patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Outcome: Indidence of post-traumatic epilepsy (time frame: 24 months after TBI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048138, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.