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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT NUMBER: 2006-000173-29 |
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For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.
To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam (LEV) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories). | during open-label therapy phase of 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months | Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months |
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Inclusion Criteria:
Other inclusion criteria may apply
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 |
|---|---|---|---|---|---|---|
| Bruges | Belgium | |||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participants Flow describes all subjects treated at least once during open-label monotherapy with Levetiracetam.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam Open- Label Treatment | Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Edegem |
| Belgium |
| Ghent | Belgium |
| Haine-Saint-Paul | Belgium |
| Jette | Belgium |
| Kortrijk | Belgium |
| Leuven | Belgium |
| Ostend | Belgium |
| Sofia | Bulgaria |
| Varna | Bulgaria |
| Hus (helsinki) | Finland |
| Kuopio | Finland |
| Tampere | Finland |
| Blaye | France |
| Bordeaux | France |
| Brest | France |
| Carcassonne | France |
| Cherbourg | France |
| Lille | France |
| Lyon | France |
| Nancy | France |
| Rennes | France |
| Saint-Brieuc | France |
| Saint-Quentin | France |
| Toulouse | France |
| Valenciennes | France |
| Częstochowa | Poland |
| Krakow | Poland |
| Olsztyn | Poland |
| Poznan | Poland |
| Warsaw | Poland |
| Biel | Switzerland |
| Lausanne | Switzerland |
| Sankt Gallen | Switzerland |
| Zurich | Switzerland |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam Open- Label Treatment | Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | 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 | Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase | Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories). | Safety population that includes all subjects that have been treated once. | Posted | Number | participants | during open-label therapy phase of 18 months |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months | Subjects with a discontinuation visit | Posted | Mean | Standard Deviation | kg | Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months |
|
|
Open-label treatment over 18 months
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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 Open- Label Treatment | Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months | 6 | 130 | 10 | 130 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | medDRA 9.0 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | medDRA 9.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | medDRA 9.0 | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | medDRA 9.0 | Non-systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | medDRA 9.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | medDRA 9.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | medDRA 9.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight decreased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 9.0 | Non-systematic Assessment |
|
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that 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 Pharma | +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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| Poland |
|
| Belgium |
|
| Bulgaria |
|
| Switzerland |
|
| Title | Measurements |
|---|---|
|
| Subjects with drug-related AEs |
|
| Subjects with AEs of severe intensity |
|
| Subjects with serious AEs |
|
| Subjects with study drug-related serious AEs |
|
| Number of deaths |
|
| Title | Denominators | Categories |
|---|
|