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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT01954121
First received: September 26, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Epilepsy
Partial Seizures
Drug: Levetiracetam
Drug: Carbamazepine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

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) ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 436
Study Start Date: September 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam
Levetiracetam 1000 mg/day
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)
Other Name: Keppra
Active Comparator: Carbamazepine
Carbamazepine 400 mg/day
Drug: 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)
Other Name: Tegretol

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954121

Contacts
Contact: UCB Clinical Trial Call Center +1 877 822 9493

Locations
China
13 Recruiting
Beijing, China
16 Recruiting
Changchun City, China
5 Recruiting
Chengdu, China
10 Recruiting
Chengdu, China
4 Recruiting
Chongqing, China
1 Recruiting
Guangzhou, China
11 Recruiting
Guangzhou, China
20 Recruiting
Guangzhou, China
26 Recruiting
Guangzhou City, China
24 Recruiting
Hangzhou, China
22 Recruiting
Harbin, China
29 Recruiting
Kunming, China
21 Recruiting
Nanjing, China
23 Recruiting
Nanjing City, China
6 Recruiting
Nanjing City, China
8 Recruiting
Nanjing City, China
27 Recruiting
Qingdao, China
15 Recruiting
Shanghai, China
2 Recruiting
Shanghai, China
18 Recruiting
Shanghai, China
14 Recruiting
Shanghai, China
19 Recruiting
Shijiazhuang, China
3 Recruiting
Suzhou, China
9 Recruiting
Taiyuan, China
25 Recruiting
Tianjin, China
12 Recruiting
Wuhan, China
7 Recruiting
Xi'an, China
17 Recruiting
Xian, China
Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB, Inc. ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01954121     History of Changes
Other Study ID Numbers: N01364
Study First Received: September 26, 2013
Last Updated: May 21, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by UCB, Inc.:
Levetiracetam
Keppra
Monotherapy
China
Epilepsy
Partial-onset Seizures

Additional relevant MeSH terms:
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Carbamazepine
Etiracetam
Piracetam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Nootropic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 29, 2014