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To evaluate the safety of Levetiracetam IV 15-minute infusion administered every 12 hours as adjunctive treatment in subjects with Partial Onset Seizures after switching from the equivalent Levetiracetam oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days) | An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18) |
| Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days) | A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention. | During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18) |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1 | Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1. | Day 1 |
| Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4 |
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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 |
|---|---|---|---|---|---|---|
| 1 | Niigata | Niigata | Japan | |||
| 2 |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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The Safety Set (SS) consisted of all subjects who started Levetiracetam intravenous (LEV IV) infusion after they had signed and dated the Informed Consent form. Participant Flow and Baseline Characteristics refer to the Safety Set (SS).
This study started to enroll subjects in July 2011 in order to end up with 4 centers in Japan.
16 subjects were treated and completed the study. All 16 subjects are included in the Safety Set.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam. Levetiracetam :
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam. Levetiracetam :
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of Treatment Emergent Adverse Events During the Entire Study Period (up to 32 Days) | An Adverse Event (AE) is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Safety Set (SS) | Posted | Number | participants | During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18) |
|
Adverse Events (AEs) were collected over the entire Study Period from Screening (1 to 14 days prior to the first intravenous infusion) over Evaluation Period (4 days) to the end of Follow-Up Period (1 to 14 days after the final intravenous infusion).
AEs refer to Safety Set (SS). The Safety Set (SS) consisted of all subjects who started Levetiracetam intravenous (LEV IV) infusion after they had signed and dated the Informed Consent form.
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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 | Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam. Levetiracetam :
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gingivitis | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB | +1 877 822 9493 (UCB) |
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| 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 |
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|
Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4. |
| Day 4 |
| Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1 | Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg. | Day 1 |
| Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4 | Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg. | Day 4 |
| Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period | Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures. | During the Evaluation Period (Day 1 to Day 4) |
| Shizuoka |
| Shizuoka |
| Japan |
| 3 | Kodaira | Tokyo | Japan |
| 4 | Yamagata-city, Yamagata | Japan |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| Height | Mean | Standard Deviation | centimeter |
|
|
|
| Primary | Incidence of Treatment Emergent Serious Adverse Events During the Entire Study Period (up to 32 Days) | A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, results in significant or persistent disability/incapacity, is a congenital anomaly/birth defect (including that occurring in a fetus), or is an important medical event that may jeopardize the subject or may require medical or surgical intervention. | Safety Set (SS) | Posted | Number | participants | During the entire Study Period from Screening (Day -14 to Day -1) over Evaluation Period (Day 1 to Day 4) to Follow-Up Period (Day 5 to Day 18) |
|
|
|
| Secondary | Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1 | Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1. | Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Day 1 |
|
|
|
| Secondary | Observed Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4 | Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4. | Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Day 4 |
|
|
|
| Secondary | Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 1 | Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 1. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg. | Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Day 1 |
|
|
|
| Secondary | Dose Normalized Plasma Trough Concentration of Levetiracetam Prior to Intravenous (iv) Infusion on Day 4 | Plasma sample for determination of Plasma trough concentration of Levetiracetam was taken prior to intravenous infusion of Levetiracetam in the morning of Day 4. Plasma trough concentration (Ctrough) was normalized to a dose of 500 mg as follows: Dose normalized Ctrough = Ctrough/last dose [mg] x 500 mg. | Pharmacokinetic Per Protocol Set (PK-PPS). This was defined as a subset of the Safety Set (SS) and consisted of subjects who had at least 1 evaluable Levetiracetam plasma concentration after intravenous administration. All 16 subjects from the SS are included in the PK-PPS. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Day 4 |
|
|
|
| Secondary | Partial (Type 1) Seizure Frequency Per Day Over the Evaluation Period | Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures. | Full Analysis Set (FAS). The FAS consisted of all subjects in the Safety Set (SS) with evaluable seizure frequency data over the Evaluation Period. All 16 subjects in the SS are included in the FAS. | Posted | Median | Inter-Quartile Range | Seizures per day | During the Evaluation Period (Day 1 to Day 4) |
|
|
|
| 0 |
| 16 |
| 5 |
| 16 |
| Toothache | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (15.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
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| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |