Trial record 1 of 1 for:
NCT01954121
Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
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| ClinicalTrials.gov Identifier: NCT01954121 |
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Recruitment Status :
Completed
First Posted : October 1, 2013
Results First Posted : August 11, 2016
Last Update Posted : August 15, 2017
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Sponsor:
UCB Pharma SA
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
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Brief Summary:
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy Partial Seizures | Drug: Levetiracetam Drug: Carbamazepine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 436 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, Randomized, Parallel-group, Active-controlled Study Comparing the Efficacy and Safety of Levetiracetam to Carbamazepine Used as Monotherapy in Subjects Newly or Recently Diagnosed as Epilepsy and Partial-onset Seizures |
| Study Start Date : | September 2013 |
| Actual Primary Completion Date : | September 2015 |
| Actual Study Completion Date : | September 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
| Arm | Intervention/treatment |
|---|---|
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Experimental: Levetiracetam
Levetiracetam 1000 mg/day
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Drug: Levetiracetam
Immediate release film-coated tablets at strengths of 250 mg and 500 mg.
Other Name: Keppra |
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Active Comparator: Carbamazepine
Carbamazepine 400 mg/day
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Drug: Carbamazepine
Immediate release tablets at a strength of 200 mg.
Other Name: Tegretol |
Primary Outcome Measures :
- Proportion of Subjects Remaining Seizure Free During the 6-months Evaluation Period [ Time Frame: 6-months Evaluation Period (From Week 4 to Week 30) ]
Secondary Outcome Measures :
- Proportion of Subjects Retained in the Study for the Duration of the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period [ Time Frame: 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 [ Time Frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) ]Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
- Time to First Seizure During the Evaluation Period [ Time Frame: From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30) ]Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
- Time to First Seizure During the Period Covering the Up Titration Period, Stabilization Period, and Evaluation Period From the First Dose of Study Drug [ Time Frame: From Randomization (Week 1) up to Evaluation Visit (Week 30) ]Number of qualifying events is reported because it is the only descriptive measure available from the proportional hazards model, that was applied.
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is of Chinese origin and ≥ 16 years of age
- Subject is newly or recently diagnosed with Epilepsy, having experienced unprovoked Partial-Onset Seizures (POS)
- Subject has experienced at least 2 unprovoked seizures in the year preceding randomization, of which at least 1 unprovoked seizure occurred in the 3 months preceding randomization
- Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or brain Magnetic Resonance Imaging (MRI) scan consistent with a diagnosis of Epilepsy with POS
Exclusion Criteria:
- Subject tests positive for human leukocyte antigen major histocompatibility complex, class I,B (HLA-B)* 1502 allele
- Subject has a history or presence of seizures of other types than Partial-Onset Seizures (POS)
- Subject has only experienced type IA nonmotor seizures
- Subject has a history or presence of seizures occurring only in clustered patterns
- Subject has a history of clinical or Electroencephalogram (EEG) findings suggestive of Idiopathic Generalized Epilepsy prior to randomization
- Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures
- Subject has a history of Status Epilepticus
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954121
Locations
Show 28 study locations
Sponsors and Collaborators
UCB Pharma SA
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Additional Information:
| Responsible Party: | UCB Pharma SA |
| ClinicalTrials.gov Identifier: | NCT01954121 |
| Other Study ID Numbers: |
N01364 |
| First Posted: | October 1, 2013 Key Record Dates |
| Results First Posted: | August 11, 2016 |
| Last Update Posted: | August 15, 2017 |
| Last Verified: | July 2017 |
Keywords provided by UCB Pharma ( UCB Pharma SA ):
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Levetiracetam Keppra Monotherapy |
China Epilepsy Partial-onset Seizures |
Additional relevant MeSH terms:
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Epilepsy Seizures Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Carbamazepine Levetiracetam Anticonvulsants Nootropic Agents Antimanic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP3A Inducers Cytochrome P-450 Enzyme Inducers |