Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002713-32 | EudraCT Number |
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
To evaluate the long term effectiveness of Levetiracetam (LEV) monotherapy on Treatment Failure Rate in subjects with newly diagnosed partial onset seizures with or without secondary generalized seizures, compared to Oxcarbazepine (OXC) monotherapy over 50 weeks from the first dose
The study duration consists of the following periods:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Levetiracetam twice a day treatment group |
|
| Oxcarbazepine | Active Comparator | Oxcarbazepine twice a day treatment group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | 250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With a Treatment Failure | Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication. | Week 0 (First Dose) to Week 50 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period | From Week 2 to Week 50 (During Treatment Period ) | |
| Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 05 | Busan | South Korea | ||||
| 10 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28395124 | Derived | Kim JH, Lee SK, Loesch C, Namgoong K, Lee HW, Hong SB; Korean N01367 Study Group. Comparison of levetiracetam and oxcarbazepine monotherapy among Korean patients with newly diagnosed focal epilepsy: A long-term, randomized, open-label trial. Epilepsia. 2017 Apr;58(4):e70-e74. doi: 10.1111/epi.13707. |
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
Participant Flow refers to the Randomized Set, consisting of all subjects who were randomized in this study.
This study started to enroll subjects in June 2011. A total of 27 investigators enrolled 353 subjects at 23 sites in Korea.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | Levetiracetam twice a day treatment Group 250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks |
| FG001 | Oxcarbazepine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Oxcarbazepine | Drug | 150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1week then 600 mg/day 1 week) |
|
24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time |
| From Week 2 to Week 50 (During Treatment Period ) |
| Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period | 48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period | From Week 2 to Week 50 (During Treatment Period ) |
| Busan |
| South Korea |
| 16 | Busan | South Korea |
| 06 | Daejeon | South Korea |
| 18 | Daejeon | South Korea |
| 23 | Gangwon-Do | South Korea |
| 08 | Goyang-si | South Korea |
| 09 | Goyang-si | South Korea |
| 07 | Gwangju | South Korea |
| 22 | Junggu | South Korea |
| 14 | Seongnam-si | South Korea |
| 01 | Seoul | South Korea |
| 02 | Seoul | South Korea |
| 03 | Seoul | South Korea |
| 04 | Seoul | South Korea |
| 11 | Seoul | South Korea |
| 12 | Seoul | South Korea |
| 13 | Seoul | South Korea |
| 15 | Seoul | South Korea |
| 17 | Seoul | South Korea |
| 20 | Seoul | South Korea |
| 21 | Seoul | South Korea |
| 19 | Ulsan | South Korea |
Oxcarbazepine twice a day treatment Group
150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline Characteristics refer to the Randomized Set, consisting of all subjects who were randomized in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam | Levetiracetam twice a day treatment Group 250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks |
| BG001 | Oxcarbazepine | Oxcarbazepine twice a day treatment Group 150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week) |
| BG002 | Total Title |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 of Subjects With a Treatment Failure | Treatment failure is defined as (1) Dropout due to related intolerable adverse event, lack of efficacy or need for addition of another Antiepileptic Drug (AED), or (2) need of a 1-step down-Titration, within 50 weeks from the first dose of study medication. | Per Protocol Set (PPS) consisted of all subjects who received at least 1 (partial) dose of study mediaction, returned at least 1 post-Baseline seizure diary and had no important protocol deviations. Subjects who discontinued the study before Week 50 for any reason other than treatment failure were excluded from the PPS. | Posted | Number | percentage of subjects | Week 0 (First Dose) to Week 50 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to the First Seizure Defined as the Time From the First Dose of Medication to the Occurrence of the First Seizure During the 48 Weeks Treatment Period | The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary. A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication. | Posted | Median | Full Range | months | From Week 2 to Week 50 (During Treatment Period ) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Achieved Seizure Freedom for 24 Consecutive Weeks During the 48 Weeks Treatment Period at Any Time | 24-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom for 24 consecutive weeks during the Treatment Period at any time | The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary. A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication. | Posted | Number | percentage of subjects | From Week 2 to Week 50 (During Treatment Period ) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Subjects Who Achieved Seizure Freedom During the 48 Weeks Treatment Period | 48-week Seizure Freedom (rate) defined as the number and percentage of subjects who achieved seizure freedom during the Treatment Period | The Full Analysis Set (FAS) consisted of all subjects who received at least 1 (partial) dose of study mediaction and returned at least 1 post-Baseline seizure diary. A randomized subject was only excluded from the FAS when there was clear evidence that the subject did not take any study medication. | Posted | Number | percentage of subjects | From Week 2 to Week 50 (During Treatment Period ) |
|
|
Adverse Events were collected up to 57 Weeks from Visit 1 (Week -1) to the end of the post-treatment period (down-titration visit, safety follow-up visit).
Adverse Events refer to the Safety Set (SS). SS consisted of all subjects who were randomized and received at least 1 (partial) dose of study medication.
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 | Levetiracetam twice a day treatment Group 250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks | 15 | 173 | 67 | 173 | ||
| EG001 | Oxcarbazepine | Oxcarbazepine twice a day treatment Group 150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week) | 15 | 174 | 93 | 174 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA17.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA17.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA17.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA17.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | +1 887 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D004828 | Epilepsies, Partial |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| D000078330 | Oxcarbazepine |
| 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 |
| D002220 | Carbamazepine |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|