Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01954121
• Other study ID #: N01364
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2013
• Last updated: February 16, 2016
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: February 2016
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Partial Seizures
• Seizures

Intervention

Drug:
• Levetiracetam
Immediate release film-coated tablets at strengths of 250 mg and 500 mg. Up-titration Period (Week 1 to Week 3): Levetiracetam (LEV) 250 mg twice daily (bid) Stabilization Period and Evaluation Period (Week 3 to Week 30): LEV 500 mg bid Down-titration Period (Week 30 up to Week 33)
• Carbamazepine
Immediate release tablets at a strength of 200 mg. Up-titration Period (Week 1 to Week 3): Carbamazepine- Immediate Release (CBZ-IR) 200 mg once daily (qd) Stabilization Period and Evaluation Period (Week 3 to Week 30): CBZ-IR 200 mg bid Down-titration Period (Week 30 up to Week 33)

Locations

Country	Name	City	State
China	13	Beijing
China	16	Changchun City
China	10	Chengdu
China	5	Chengdu
China	4	Chongqing
China	1	Guangzhou
China	11	Guangzhou
China	20	Guangzhou
China	26	Guangzhou City
China	24	Hangzhou
China	22	Harbin
China	29	Kunming
China	21	Nanjing
China	23	Nanjing City
China	6	Nanjing City
China	8	Nanjing City
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	7	Xi'an
China	17	Xian

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma SA

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects remaining seizure free during the 6-months Evaluation Period		6-months Evaluation Period (From Week 4 to Week 30)	No
Secondary	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	No
Secondary	Time to first seizure or discontinuation due to an Adverse Event (AE) / Lack of Efficacy (LOE) during the Evaluation Period		From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)	No
Secondary	Time to first seizure during the Evaluation Period		From first day in the Evaluation Period (Week 4) up to end of the Evaluation Period (Week 30)	No
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		From Randomization (Week 1) up to Evaluation Visit (Week 30)	No