A Phase 2 interventional study of Levetiracetam in Epilepsy, sponsored by UCB Pharma SA. Completed at 23 sites in 6 countries. Open to participants aged 1 Month to 4 Years. Per ClinicalTrials.gov, last updated 2015-07-15.
Sponsored by UCB Pharma SA · Phase 2, Interventional, and Treatment
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.
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:
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:
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →UCB Pharma SA is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Levetiracetam
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).
Also known as: Keppra®, ucb L059
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)
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)
Subjects were recruited from sites in the United States, Belgium, Germany, France, Mexico, and Turkey. The study began in May 2008 and continued until March 2010, with the last subject's visit occurring in March of 2010.
| Milestone | Levetiracetam |
|---|---|
| Started | 19 |
| Completed | 16 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Other: unable to obtain iv & pk samples | 1 |
| Withdrew: Other: iv dose needed to be changed | 1 |
| Subjects | Levetiracetam |
|---|---|
| Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days) | 12 |
| Subjects | Levetiracetam |
|---|---|
| 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) | 6 |
| Consecutive doses | Levetiracetam |
|---|---|
| Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received | 2.89 ± 1.41 |
Collected over Up to 4 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levetiracetam | — | 4/19 (21.1%) | 10/19 (52.6%) |
| Event | Levetiracetam |
|---|---|
| PNEUMONIAInfections and infestations | 2/19 |
| METABOLIC ACIDOSISMetabolism and nutrition disorders | 2/19 |
| BRADYCARDIACardiac disorders | 1/19 |
| CARDIAC ARRESTCardiac disorders | 1/19 |
| PYREXIAGeneral disorders | 1/19 |
| ABDOMINAL SEPSISInfections and infestations | 1/19 |
| ELECTROCARDIOGRAM QT PROLONGEDInvestigations | 1/19 |
| CONVULSIONNervous system disorders | 1/19 |
| RESPIRATORY FAILURERespiratory, thoracic and mediastinal disorders | 1/19 |
| Event | Levetiracetam |
|---|---|
| PYREXIAGeneral disorders | 2/19 |
| HYPOTENSIONVascular disorders | 2/19 |
| BRADYCARDIACardiac disorders | 1/19 |
| EYE SWELLINGEye disorders | 1/19 |
| VOMITINGGastrointestinal disorders | 1/19 |
| IRRITABILITYGeneral disorders | 1/19 |
| PAINGeneral disorders | 1/19 |
| PUNCTURE SITE PAINGeneral disorders | 1/19 |
| PROCEDURAL PAINInjury, poisoning and procedural complications | 1/19 |
| ELECTROENCEPHALOGRAMInvestigations | 1/19 |
| Age, Categorical(Participants) | Levetiracetam |
|---|---|
| <=18 years | 19 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Levetiracetam |
|---|---|
| Mean | 1.59 ± 1.24 |
| Sex: Female, Male(Participants) | Levetiracetam |
|---|---|
| Female | 7 |
| Male | 12 |
| Region of Enrollment(participants) | Levetiracetam |
|---|---|
| United States | 7 |
| Mexico | 8 |
| Belgium | 1 |
| Turkey | 2 |
| Germany | 1 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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