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To demonstrate the non-inferiority of Levetiracetam (1000 mg/day) versus Carbamazepine Immediate-Release (400 mg/day) used as monotherapy for at least 6 months in a Chinese population with newly or recently diagnosed Epilepsy who are experiencing Partial-Onset Seizures (POS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levetiracetam | Experimental | Levetiracetam 1000 mg/day |
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| Carbamazepine | Active Comparator | Carbamazepine 400 mg/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levetiracetam | Drug | Immediate release film-coated tablets at strengths of 250 mg and 500 mg.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period | 6-months Evaluation Period (From Week 4 to Week 30) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period | From Week 1 to Week 30 | |
| Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period |
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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 |
|---|---|---|---|---|---|---|
| 13 | Beijing | China | ||||
| 16 |
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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Participant Flow refers to the Randomized Set which consists of all subjects who were randomized in this study.
This study started to enroll subjects in China in September 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levetiracetam | During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg. |
| FG001 | Carbamazepine-IR |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Carbamazepine | Drug | Immediate release tablets at a strength of 200 mg.
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Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
| From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) |
| Time to First Seizure During the Evaluation Period | Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. | From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) |
| Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug | Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. | From Randomization (Week 1) up to Evaluation Visit (Week 30) |
| Changchun |
| China |
| 10 | Chengdu | China |
| 5 | Chengdu | China |
| 4 | Chongqing | China |
| 11 | Guangzhou | China |
| 1 | Guangzhou | China |
| 20 | Guangzhou | China |
| 26 | Guangzhou | China |
| 24 | Hangzhou | China |
| 22 | Harbin | China |
| 29 | Kunming | China |
| 21 | Nanjing | China |
| 23 | Nanjing | China |
| 6 | Nanjing | China |
| 8 | Nanjing | China |
| 27 | Qingdao | China |
| 14 | Shanghai | China |
| 15 | Shanghai | China |
| 18 | Shanghai | China |
| 2 | Shanghai | China |
| 19 | Shijiazhuang | China |
| 3 | Suzhou | China |
| 9 | Taiyuan | China |
| 25 | Tianjin | China |
| 12 | Wuhan | China |
| 17 | Xi'an | China |
| 7 | Xi'an | China |
During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg. |
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| NOT COMPLETED |
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The Baseline Characteristics refers to the Safety Set (SS) which consists of all subjects who were randomized and received at least 1 dose of trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Levetiracetam (Safety Set) | During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg. |
| BG001 | Carbamazepine-IR (Safety Set) | During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg. |
| BG002 | Total Title |
| 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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| 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 | Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | Posted | Number | percentage of subjects | 6-months Evaluation Period (From Week 4 to Week 30) |
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| Secondary | Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | Posted | Number | percentage of subjects | From Week 1 to Week 30 |
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| Secondary | Time to First Seizure or Discontinuation Due to an Adverse Event (AE) / Lack of Efficacy (LOE) During the Evaluation Period | Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | Posted | Number | events | From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) |
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| Secondary | Time to First Seizure During the Evaluation Period | Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | Posted | Number | events | From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) |
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| Secondary | Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug | Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied. | The Per Protocol Set consisted of all subjects in the Full Analysis Set who entered the Evaluation Period and who did not have any important protocol deviations determined to impact the interpretation of efficacy. Criteria that might impact the assessment of efficacy was determined during a Data Review Meeting before the database lock. | Posted | Number | events | From Randomization (Week 1) up to Evaluation Visit (Week 30) |
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Adverse Events (AEs) were collected from Visit 1 (Week 0) until Safety Follow Up Visit (Week 35).
Adverse Events refer to the Safety Set (SS), which is a subset of the Randomized Set and consisted of all subjects who received at least 1 dose of study medication after randomization, either Levetiracetam or Carbamezepine immediate-release.
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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 (Safety Set) | During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg. | 9 | 218 | 92 | 218 | ||
| EG001 | Carbamazepine-IR (Safety Set) | During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg. | 11 | 215 | 93 | 215 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA18.0 | Non-systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA18.0 | Non-systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
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| Brain contusion | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
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| Burns third degree | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
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| Epidural haemorrhage | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
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| Rib Fracture | Injury, poisoning and procedural complications | MedDRA18.0 | Non-systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA18.0 | Non-systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA18.0 | Non-systematic Assessment |
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| Status epilepticus | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
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| Menopausal symptoms | Reproductive system and breast disorders | MedDRA18.0 | Non-systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA18.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA18.0 | Non-systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA18.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA18.0 | Non-systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA18.0 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA18.0 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA18.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA18.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Cares | +1 887 822 9493 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077287 | Levetiracetam |
| D002220 | Carbamazepine |
| 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 |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| >=65 years |
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| Male |
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The non-inferiority margin for the adjusted difference in seizure free proportion in the LEV minus the seizure free proportion in the CBZ-IR group was set to absolute -20% points.
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