EpilepsyPhase 2NCT00505934
Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
A Phase 2 study testing Levetiracetam in people with Epilepsy, run by UCB Pharma SA at 23 sites in 6 countries.
Trial summary
Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years. Read more about this study
- Who is it for?
- Ages 1 month to 4 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 23 sitesin 6 countries
- Study dates
- May 2008to Mar 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 1 month to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female between 1 month and 4 years of age, inclusive
- The subject suffers from epilepsy (except status epilepticus)
- The subject is requiring levetiracetam IV treatment in place of oral therapy for a short period of time
Who cannot join
- The subject has difficult venous accessibility
- History of status epilepticus during the 3 months prior to Screening
- The subject is on felbamate with less than 18 months continuous exposure before Screening.
- The subject presents with current depressive symptoms, current suicidal ideation and/or behavior.
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
United States6 sites
Study site
Buffalo, New York
Study site
Fort Worth, Texas
Study site
Nashville, Tennessee
Study site
Philadelphia, Pennsylvania
Study site
Richmond, Virginia
Study site
San Diego, California
Mexico6 sites
Study site
Aguascalientes
Study site
Guadalajara
Study site
Mexico City
Study site
Puebla City, CP
Study site
Puebla City
Study site
Torreón, Coahuila
France4 sites
Study site
Amiens
Study site
Lille
Study site
Paris
Study site
Vandœuvre-lès-Nancy
About this study
Official title: Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy
Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.
Read the detailed description
The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (1 month to 4 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment.
The evaluation period was to be considered as one complete set of 4 pharmacokinetic (PK) samples for a maximum of 4 days;
For children already taking levetiracetam oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose (always in twice daily regimen) within the following dose range, calculated on the basis of their age and weight:
- Children ≥ 1 month to < 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily) to 42 mg/kg/day (i.e 21 mg/kg/day twice daily);
- Children ≥ 6 months to < 4 years:20 mg/kg/day (i.e. 10 mg/kg twice daily) to 60 mg/kg/day (i.e 30 mg/kg/day twice daily).
The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam.
For children not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dose will correspond to their age and weight as follows:
- Children ≥ 1 month to < 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily).
- Children ≥ 6 months to < 4 years: 20 mg/kg/day (i.e. 10 mg/kg twice daily).
However, when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous (LEV IV) dose could be modified after one day.
Subjects were hospitalized for the duration of the levetiracetam intravenous (LEV IV) treatment.
- Conditions
- Epilepsy
- Being tested
- Levetiracetam
- Keywords
- Epilepsy, Child, Levetiracetam, Keppra®, Infusion, Intravenous
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called Keppra®, ucb L059
Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
- Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
- Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
- Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).
- Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily).
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Not described Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
Measured: Treatment period (up to 4 days)
Secondary outcomes (2)
Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)
Measured: Treatment period (up to 4 days)
Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
Measured: Treatment period (up to 4 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2007 (estimated)
- Study startMay 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505934
- Sponsor's protocol ID
- N01275
- Other IDs
- 2007-003517-13
- Status last verified
- Jun 2015
- First submitted
- 20 Jul 2007
- Last updated
- 15 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Weinstock A, Ruiz M, Gerard D, Toublanc N, Stockis A, Farooq O, Dilley D, Karmon Y, Elgie MJ, Schiemann-Delgado J. Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy. J Child Neurol. 2013 Nov;28(11):1423-1429. doi: 10.1177/0883073813480241. Epub 2013 Mar 26.
PubMed 23533164
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-arm, Multi-center, Pharmacokinetic, Safety and Tolerability Study of Levetiracetam Intravenous Infusion in Children (1 Month- 4 Years Old) With Epilepsy
- ClinicalTrials.gov ID
- NCT00505934
- Acronym / sponsor ID
- N01275
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Child, Levetiracetam, Keppra®, Infusion, Intravenous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- UCB Pharma SAIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Jul 2007 (estimated)
- Results
- Posted 25 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. The objective of the current study is to assess the safety, tolerability, and pharmacokinetics, of this formulation in children aged 1 month to 4 years.
Detailed description
The primary objective of this study was to evaluate the safety and tolerability of levetiracetam intravenous 15-minute infusion administered every 12 hours, either as adjunctive treatment or monotherapy in children (1 month to 4 years old) with epilepsy (except status epilepticus), either after switching from the equivalent levetiracetam oral dose administration or as a new antiepileptic treatment.
The evaluation period was to be considered as one complete set of 4 pharmacokinetic (PK) samples for a maximum of 4 days;
For children already taking levetiracetam oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose (always in twice daily regimen) within the following dose range, calculated on the basis of their age and weight:
- Children ≥ 1 month to < 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily) to 42 mg/kg/day (i.e 21 mg/kg/day twice daily);
- Children ≥ 6 months to < 4 years:20 mg/kg/day (i.e. 10 mg/kg twice daily) to 60 mg/kg/day (i.e 30 mg/kg/day twice daily).
The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam.
For children not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dose will correspond to their age and weight as follows:
- Children ≥ 1 month to < 6 months: 14 mg/kg/day (i.e. 7 mg/kg twice daily).
- Children ≥ 6 months to < 4 years: 20 mg/kg/day (i.e. 10 mg/kg twice daily).
However, when necessary for the safety of the subject or when the investigator deemed it appropriate the levetiracetam intravenous (LEV IV) dose could be modified after one day.
Subjects were hospitalized for the duration of the levetiracetam intravenous (LEV IV) treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: Levetiracetam |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or female between 1 month and 4 years of age, inclusive
- The subject suffers from epilepsy (except status epilepticus)
- The subject is requiring levetiracetam IV treatment in place of oral therapy for a short period of time
Key exclusion criteria (4 listed)
- The subject has difficult venous accessibility
- History of status epilepticus during the 3 months prior to Screening
- The subject is on felbamate with less than 18 months continuous exposure before Screening.
- The subject presents with current depressive symptoms, current suicidal ideation and/or behavior.
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: Keppra®, ucb L059Intravenous 100 mg/mL, twice a day, maximum of 4 days Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:. * Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily); * Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily). For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows: * Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily). * Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily). | Drug | Levetiracetam |
Primary outcome
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days)
Time frame: Treatment period (up to 4 days)
2 secondary outcomes
Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 28 mg/kg/Day for Subjects <6 Months; >40mg/kg/Day for Subjects ≥6 Months) During the Treatment Period (up to 4 Days)
Time frame: Treatment period (up to 4 days)
Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received
Time frame: Treatment period (up to 4 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23533164Weinstock A, Ruiz M, Gerard D, Toublanc N, Stockis A, Farooq O, Dilley D, Karmon Y, Elgie MJ, Schiemann-Delgado J. Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy. J Child Neurol. 2013 Nov;28(11):1423-1429. doi: 10.1177/0883073813480241. Epub 2013 Mar 26.
- FDA Safety Alerts and LinksLink provided by the sponsor.
- Product InformationLink provided by the sponsor.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Levetiracetam in people with Epilepsy, run by UCB Pharma SA at 23 sites in 6 countries.
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 3 inclusion and 4 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 15 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Mexico, France, Germany, Belgium and 1 more country. 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 25 Feb 2011). 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?
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days) (time frame: Treatment period (up to 4 days)). 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 NCT00505934, which also lists 1 linked publication.
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 15 Jul 2015.