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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-005722-23 | EudraCT Number |
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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 4 to 16 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 (4 to 16 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 tablets or oral solution prior to entering the study, the levetiracetam intravenous (LEV IV) dose will be equivalent (mg-for-mg) to their oral dose. The first intravenous (IV) infusion was to be administered 12 hours after the last oral dose of levetiracetam.
For children not taking levetiracetam oral tablets or oral solution prior to entering the study:
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 IV treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 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. Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days) | Treatment period (up to 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days) | Treatment period (up to 4 days) | |
| Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | United States | ||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Subjects were recruited from sites in the United States, Belgium, Germany, France, Mexico, and Turkey. The study began in September 2007 and continued until February 2010, with the last subject's visit occurring in February of 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Treatment period (up to 4 days) |
| Boston |
| Massachusetts |
| United States |
| Chesterfield | Missouri | United States |
| Buffalo | New York | United States |
| Philadelphia | Pennsylvania | United States |
| Nashville | Tennessee | United States |
| Fort Worth | Texas | United States |
| Richmond | Virginia | United States |
| Milwaukee | Wisconsin | United States |
| Brussels | Belgium |
| Ghent | Belgium |
| Leuven | Belgium |
| Amiens | France |
| Lille | France |
| Paris | France |
| Heidelberg | Germany |
| Kehl | Germany |
| Torreón | Coahuila | Mexico |
| Puebla City | CP | Mexico |
| Aguascalientes | Mexico |
| Guadalajara | Mexico |
| Mexico City | Mexico |
| Puebla City | Mexico |
| Ankara | Turkey (Türkiye) |
| Izmir | Turkey (Türkiye) |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 4 Days) | All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis. | Posted | Number | Subjects | Treatment period (up to 4 days) |
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| Secondary | Number of Subjects Who Received High-dose Levetiracetam Intravenous (LEV IV) (More Than 40 mg/kg/Day) During the Treatment Period (up to 4 Days) | All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis. | Posted | Number | Subjects | Treatment period (up to 4 days) |
|
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| Secondary | Number of Consecutive Levetiracetam Intravenous (LEV IV) Doses Received | All 33 subjects enrolled in the study were in the Intent to Treat (ITT) population and are included in this analysis. | Posted | Mean | Standard Deviation | Consecutive doses | Treatment period (up to 4 days) |
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Up to 4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily). | 3 | 33 | 12 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VOMITING | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NAUSEA | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| DRY MOUTH | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
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| PYREXIA | General disorders | MedDRA (9.0) | Non-systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA (9.0) | Non-systematic Assessment |
| |
| CONVULSION | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA (9.0) | Non-systematic Assessment |
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UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Mexico |
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| Belgium |
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| Turkey |
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| Germany |
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