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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT01954121
First received: September 26, 2013
Last updated: August 12, 2015
Last verified: August 2015
  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 Pharma:

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

Locations
China
13
Beijing, China
16
Changchun City, China
10
Chengdu, China
5
Chengdu, China
4
Chongqing, China
11
Guangzhou, China
20
Guangzhou, China
1
Guangzhou, China
26
Guangzhou City, China
24
Hangzhou, China
22
Harbin, China
29
Kunming, China
21
Nanjing, China
6
Nanjing City, China
8
Nanjing City, China
23
Nanjing City, China
27
Qingdao, China
18
Shanghai, China
15
Shanghai, China
14
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
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 Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01954121     History of Changes
Other Study ID Numbers: N01364
Study First Received: September 26, 2013
Last Updated: August 12, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by UCB Pharma:
Levetiracetam
Keppra
Monotherapy
China
Epilepsy
Partial-onset Seizures

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

ClinicalTrials.gov processed this record on September 01, 2015