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EpilepsyPhase 2NCT01463033

Levetiracetam to Prevent Post-Traumatic Epilepsy

A Phase 2 study testing Levetiracetam in people with Epilepsy and Post-traumatic Epilepsy, run by Pavel Klein at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful. Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of epilepsy. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Epilepsy, Post-traumatic Epilepsy
What is being tested?
Levetiracetam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
2 sitesUnited States
Study dates
Apr 2005to Feb 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Acute head injury associated with one of the following:
  • Intracranial hemorrhage, including epidural, subdural and intracerebral hemorrhage or with cerebral contusion(s) of any size; Penetrating (foreign body) head injury; Skull fracture and dural tear; Seizure within 8 hours of head injury
  • Onset of head injury within 8-hours of proposed treatment initiation.
  • Glasgow Coma Scale 6-15.

Who cannot join

  • Clinical contraindications:
  • Previous epilepsy or status epilepticus.
  • Any systemic illness or unstable medical condition that might pose additional risk, including: renal insufficiency, other unstable metabolic or endocrine disturbances, and active systemic cancer.
  • Psychosis within six months of enrollment as determined by history of hospitalization for psychosis or medications for psychosis.
  • Moderate to severe mental retardation (IQ< 55 or>2 school grade levels below the expected for age [expected age = grade level +5]).
  • Clinical/Laboratory Indicators:
Show all 14Show fewer
  • Serum creatinine > 1.5 on the day of treatment initiation for adults.
  • Serum creatinine ≥1.5 for subjects ≥17 years old, ≥1.0 for subjects 13-17 years old and ≥0.7 for subjects 6-12 years old.
  • Pregnancy
  • Use of any CNS-active investigational drugs within 3 months of enrollment.
  • Use of Antiepileptic Drugs (AEDs) within two months of enrollment, for any indication.
  • Allergy/sensitivity to study drugs or their formulations:
  • Active drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements:
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

  • MedStar Research Institute

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Pilot: Levetiracetam to Prevent Post-Traumatic Epilepsy

Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful. Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of epilepsy. It has a favorable side effect and pharmacokinetic profile. It is therefore a strong candidate for a clinical trial of epilepsy prevention following traumatic brain injury (TBI). However, there has been no experience in administering levetiracetam rapidly to individuals with acute TBI. The investigators propose to initiate the evaluation of levetiracetam in prevention of post-traumatic epilepsy by determining the safety, tolerability, pharmacokinetics and feasibility of acute and chronic administration of levetiracetam to individuals with head injury with a high risk for developing post-traumatic epilepsy. Further, the investigators will follow subjects for 2 years after injury in order to obtain pilot data about effect of levetiracetam on PTE. This pilot study is the first step in evaluation of levetiracetam in prevention of post-traumatic epilepsy.

Being tested
Levetiracetam
Keywords
Post-Traumatic epilepsy, Traumatic brain injury, Epilepsy prevention, Levetiracetam
Medical subject headings
Epilepsy, Epilepsy, Post-Traumatic, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LevetiracetamDrug

    Also called Keppra (brand name)

    55 mg/kg/day given in 2 divided doses 12 hours apart

Study groups in NCT01463033
Study groupRoleWhat they receive
LevetiracetamActive comparator66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
Receives: Drug: Levetiracetam
No Intervention ControlNo intervention60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Post-Traumatic Epilepsy

    occurrence of PTE (Post-Traumatic Epilepsy)

    Measured: 2 years

Secondary outcomes (1)

  1. Adverse Events

    The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period.

    Measured: 30 day treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2011 (estimated)
  2. Study startApr 2005
  3. Primary completionJun 2008
  4. Study completionFeb 2010

Resources

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 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01463033
Sponsor's protocol ID
NS45656
Status last verified
Dec 2015
First submitted
12 Oct 2011
Last updated
13 Jan 2016
Data monitoring committee
Yes

Publications

  • Pearl PL, McCarter R, McGavin CL, Yu Y, Sandoval F, Trzcinski S, Atabaki SM, Tsuchida T, van den Anker J, He J, Klein P. Results of phase II levetiracetam trial following acute head injury in children at risk for posttraumatic epilepsy. Epilepsia. 2013 Sep;54(9):e135-7. doi: 10.1111/epi.12326. Epub 2013 Jul 22.

    PubMed 23876024

  • Klein P, Herr D, Pearl PL, Natale J, Levine Z, Nogay C, Sandoval F, Trzcinsky S, Atabaki SM, Tsuchida T, van den Anker J, Soldin SJ, He J, McCarter R. Results of phase II pharmacokinetic study of levetiracetam for prevention of post-traumatic epilepsy. Epilepsy Behav. 2012 Aug;24(4):457-61. doi: 10.1016/j.yebeh.2012.05.011. Epub 2012 Jul 7.

    PubMed 22771222

  • Klein P, Herr D, Pearl PL, Natale J, Levine Z, Nogay C, Sandoval F, Trzcinski S, Atabaki SM, Tsuchida T, van den Anker J, Soldin SJ, He J, McCarter R. Results of phase 2 safety and feasibility study of treatment with levetiracetam for prevention of posttraumatic epilepsy. Arch Neurol. 2012 Oct;69(10):1290-5. doi: 10.1001/archneurol.2012.445.

    PubMed 22777131

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Levetiracetam in people with Epilepsy and Post-traumatic Epilepsy, run by Pavel Klein at 2 sites in United States.

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 14 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: finished, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Post-Traumatic Epilepsy (time frame: 2 years). 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 NCT01463033, which also lists 3 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 13 Jan 2016.

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