Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Subjects received open-label Levetiracetam. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Pharmaceutical form: oral tablets Route of administration: Oral use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Participants With Treatment Emergent Adverse Events | An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). | From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
- Need for an additional Antiepileptic Drug (AED).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 2273 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beroun | Czechia | |||||
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participant Flow refers to the Intention-to-Treat (ITT) Set.
The study started to enroll patients in August 2005 and concluded in May 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | Subjects received open-label Levetiracetam. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Characteristics refer to the Intention-to-Treat (ITT) population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | Subjects received open-label 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 | Percentage Participants With Treatment Emergent Adverse Events | An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design). | Safety Set | Posted | Number | percentage of participants | From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks |
|
Adverse events were collected from the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levetiracetam | Subjects received open-label Levetiracetam. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Encephalopathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB | Cares | +1844 599 | 2273 | UCBCares@ucb.com |
Not provided
| ID | Term |
|---|---|
| D004830 | Epilepsy, Tonic-Clonic |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Brno |
| Czechia |
| České Budějovice | Czechia |
| Prague | Czechia |
| Rychnov nad Kněžnou | Czechia |
| Budapest | Hungary |
| Debrecen | Hungary |
| Pécs | Hungary |
| Szeged | Hungary |
| Bialystok | Poland |
| Gdansk | Poland |
| Katowice | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Szczecin | Poland |
| Warsaw | Poland |
| Gothenburg | Sweden |
| Helsingborg | Sweden |
| Huddinge | Sweden |
| Karlstad | Sweden |
| Uppsala | Sweden |
| Withdrawal by Subject |
|
| Remission |
|
| Planned pregancy |
|
| Switch to commercially available LEV |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 4 |
| 66 |
| 0 |
| 66 |
| Polyneuropathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Completed suicide | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |