Epilepsy, Post-TraumaticPhase 3TRACKNCT00566046
Prevention of Post-traumatic Seizures With Levetiracetam
A Phase 3 study testing Levetiracetam in people with Epilepsy, Post-Traumatic, run by Rennes University Hospital at 15 sites in France.
Trial summary
Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Post-Traumatic
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 15 sitesFrance
- Study dates
- Nov 2007to May 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years old
- Patient with severe brain injury defined as follow:
- Initial Glasgow Coma score (assessed on the scene of the accident) <= 8 related to the brain injury
- Stage 2 to 4 on the TDM US TCDB classification
- Initial brain CT scan performed within 48 hours after hospital admission
- Either a male or a nonpregnant, non-lactating female who is using adequate contraceptive method (a urine laboratory pregnancy test must be negative at baseline)
- Written informed consent from the patient's next-of-kin. If no relative is present as the time of inclusion, the patients will be included according to the emergency procedure
Who cannot join
- Isolated extradural hematoma
- Medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, HIV, etc.)
- Current participation in an other protocol or within one month before study entry
- Previous treatment with Levetiracetam
- Patient's follow-up judged to be difficult by the investigator
- Known allergy to either Levetiracetam or products derived from pyrrolidone or one of its excipients
- Epileptic patient treated or not (except patients treated with benzodiazepines who can be included in this protocol)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Neurologie - CHU Angers
Angers
Neurology - CHU Bordeaux
Bordeaux
Neurologie - CHU Caen
Caen
Neurochirurgie-CHU Grenoble
Grenoble
Neurology - CHU Rennes
Grenoble
Neurophysiologie Clinique - CHU Lille
Lille
Neurophysiologie clinique - CHU Lyon (Hôpital neurologique)
Lyon
Beurophysiologie clinique - CHU Marseille
Marseille
Epileptologie - CHU Montpellier
Montpellier
Neurologie - CHU Nancy
Nancy
Neurochirurgie-Paris Saint Anne
Paris, 75674
Neurologie - CHU Rennes
Rennes, 35000
Explorations Fonctionnelles Neurologiques - CHU Nantes
Rennes
Neurologie - CHU Rouen
Rouen
Neurologie - CHU Tours Hopital Trousseau
Tours
About this study
Official title: Prospective, Randomized, Double-blind Study Assessing the Effects of Levetiracetam Compared to Placebo in the Prevention of Early Epileptic Seizures and Late Epilepsy in Patients With Severe Traumatic Brain Injury
Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early seizures but no treatment has demonstrated any preventive effect against late epilepsy. Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients and has pharmacologic properties that could also be interesting for the prevention of post-traumatic epilepsy.
- Conditions
- Epilepsy, Post-Traumatic
- Being tested
- Levetiracetam, Placebo
- Medical subject headings
- Epilepsy, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
PlaceboDrug
1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Not described Receives: Drug: Levetiracetam |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury
Measured: one year
Secondary outcomes (2)
Rate of early seizures and of late epilepsy; treatment effects according to the patient's severity, the TDM US Traumatic Coma Data Bank, and the number of regions traumatized; safety of Levetiracetam
Measured: One year
Global prognosis (Glasgow Outcome Scale)
Measured: 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionDec 2009
- Study completionMay 2010
Why it stopped: Sponsor decision because of to small enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Pharma
- Responsible party
- Sponsor
- Investigators
- Arnaud Biraben, MD, Principal investigator, Rennes University HospitalBruno Laviolle, MD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566046
- Sponsor's protocol ID
- EudraCT: 2006-006518-13
- Other IDs
- CIC0203/60, LOC/06-06
- Acronym
- TRACK
- Status last verified
- Jun 2012
- First submitted
- 29 Nov 2007
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-blind Study Assessing the Effects of Levetiracetam Compared to Placebo in the Prevention of Early Epileptic Seizures and Late Epilepsy in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00566046
- Acronym / sponsor ID
- TRACK / EudraCT: 2006-006518-13
- Conditions
- Epilepsy, Post-Traumatic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision because of to small enrollment
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- UCB Pharma
- Study start
- Nov 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Nov 2007 (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.
Post-traumatic seizures can appear frequently after a severe traumatic brain injury. Two types of seizures are usually identified: early seizures during the week following the trauma and late epilepsy afterward. Several antiepileptic drugs are usually used to prevent early seizures but no treatment has demonstrated any preventive effect against late epilepsy. Levetiracetam is an antiepileptic drug usually used for the treatment of epileptic patients and has pharmacologic properties that could also be interesting for the prevention of post-traumatic epilepsy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: Levetiracetam |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 18 years old
- Patient with severe brain injury defined as follow:
- Initial brain CT scan performed within 48 hours after hospital admission
- Either a male or a nonpregnant, non-lactating female who is using adequate contraceptive method (a urine laboratory pregnancy test must be negative at baseline)
- Written informed consent from the patient's next-of-kin. If no relative is present as the time of inclusion, the patients will be included according to the emergency procedure
Key exclusion criteria (7 listed)
- Isolated extradural hematoma
- Medical decision to limit patient's care (terminal stage of a cancer, hematological malignancies, HIV, etc.)
- Current participation in an other protocol or within one month before study entry
- Previous treatment with Levetiracetam
- Patient's follow-up judged to be difficult by the investigator
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 |
|---|---|---|
| LevetiracetamAlso: Keppra1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months | Drug | Levetiracetam |
| Placebo1500 mg/day orally until the first episode of late epilepsy for a maximum duration of 3 months | Drug | Placebo |
Primary outcome
Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury
Time frame: one year
2 secondary outcomes
Rate of early seizures and of late epilepsy; treatment effects according to the patient's severity, the TDM US Traumatic Coma Data Bank, and the number of regions traumatized; safety of Levetiracetam
Time frame: One year
Global prognosis (Glasgow Outcome Scale)
Time frame: 3 months, 6 months and 1 year
Results and safety
The study was stopped early (reason given: Sponsor decision because of to small enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
Related trials for Epilepsy, Post-Traumatic
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 4
Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Seizures, Traumatic Brain Injuries
Active, not recruitingPhase 1
Imaging of Neuro-Inflammation and the Risk for Post-Traumatic Epilepsy
Epilepsy, Post-Traumatic
Not yet recruitingObservational study
Prognosis of Epilepsy With Post-traumatic Stress Disorder and Surgery
Epilepsies, Focal, Drug Restistant Epilepsie
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Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
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.
Arnaud Biraben, MD principal investigator
Rennes University Hospital
Bruno Laviolle, MD study chair
Rennes University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam in people with Epilepsy, Post-Traumatic, run by Rennes University Hospital at 15 sites in France.
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 7 inclusion and 7 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 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. 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: Sponsor decision because of to small enrollment). 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?
Time to early epileptic seizures (<= 8 days) and late epilepsy (from day 9 to 1 year) in patients with severe traumatic brain injury (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2012.