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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy; Partial Seizures

Intervention: Levetiracetam (Drug); Carbamazepine (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: UCB Pharma SA

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

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).

Clinical Details

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

Primary outcome: Proportion of subjects remaining seizure free during the 6-months Evaluation Period

Secondary outcome:

Proportion of subjects retained in the study for the duration of the period covering the Up Titration Period, Stabilization Period, and Evaluation Period

Time to first seizure or discontinuation due to an Adverse Event (AE) / Lack of Efficacy (LOE) during the Evaluation Period

Time to first seizure during the Evaluation Period

Time to first seizure during the period covering the Up Titration Period, Stabilization Period, and Evaluation Period from the first dose of study drug

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

13, Beijing, China

16, Changchun City, China

10, Chengdu, China

5, Chengdu, China

4, Chongqing, China

26, Guangzhou City, China

1, Guangzhou, China

11, Guangzhou, China

20, Guangzhou, China

24, Hangzhou, China

22, Harbin, China

29, Kunming, China

23, Nanjing City, China

6, Nanjing City, China

8, Nanjing City, China

21, 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

7, Xi'an, China

17, Xian, China

Additional Information

Starting date: September 2013
Last updated: August 12, 2015

Page last updated: August 23, 2015

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