Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures
NCT ID: NCT01954121
Last Updated: 2017-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
436 participants
INTERVENTIONAL
2013-09-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Levetiracetam
Levetiracetam 1000 mg/day
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
Carbamazepine 400 mg/day
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
ALL
No
Sponsors
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UCB Pharma SA
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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13
Beijing, , China
16
Changchun, , China
10
Chengdu, , China
5
Chengdu, , China
4
Chongqing, , China
11
Guangzhou, , China
1
Guangzhou, , China
20
Guangzhou, , China
26
Guangzhou, , China
24
Hangzhou, , China
22
Harbin, , China
29
Kunming, , China
21
Nanjing, , China
23
Nanjing, , China
6
Nanjing, , China
8
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
17
Xi'an, , China
7
Xi'an, , China
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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N01364
Identifier Type: -
Identifier Source: org_study_id
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