Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy
NCT ID: NCT00160654
Last Updated: 2020-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
251 participants
INTERVENTIONAL
2003-11-24
2006-12-12
Brief Summary
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The optimal dose in daily clinical practice will be used.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levetiracetam
Subjects received open-label Levetiracetam.
Levetiracetam
* Pharmaceutical form: oral tablets
* Concentration: 500 mg
* Route of administration: Oral use
Interventions
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Levetiracetam
* Pharmaceutical form: oral tablets
* Concentration: 500 mg
* Route of administration: Oral use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1.
* Use of one (1), but no more than two (2) concomitant marketed antiepileptic drugs (AEDs) at the time of trial entry.
Exclusion Criteria
* Presence of known pseudoseizures within the last year.
* Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors.
* Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
UCB (+1 844 599 2273)
Locations
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N01036 808
Hong Kong, , Hong Kong
N01036 842
Hong Kong, , Hong Kong
N01036 815
Kwun Tong, , Hong Kong
N01036 811
Kuala Lumpur, , Malaysia
N01036 812
Kuala Lumpur, , Malaysia
N01036 813
Kuala Lumpur, , Malaysia
N01036 830
Manila, , Philippines
N01036 831
Manila, , Philippines
N01036 829
Quezon, , Philippines
N01036 804
Singapore, , Singapore
N01036 806
Singapore, , Singapore
N01036 807
Singapore, , Singapore
N01036 828
Changhua, , Taiwan
N01036 827
Hualien City, , Taiwan
N01036 825
Kaohsiung City, , Taiwan
N01036 834
Kaohsiung City, , Taiwan
N01036 835
Kaohsiung City, , Taiwan
N01036 817
Taichung, , Taiwan
N01036 823
Taichung, , Taiwan
N01036 818
Tainan City, , Taiwan
N01036 819
Taipei, , Taiwan
N01036 820
Taipei, , Taiwan
N01036 821
Taipei, , Taiwan
N01036 822
Taoyuan District, , Taiwan
N01036 809
Bangkok, , Thailand
N01036 840
Bangkok, , Thailand
N01036 841
Bangkok, , Thailand
N01036 839
Chiang Mai, , Thailand
N01036 810
Khon Kaen, , Thailand
Countries
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References
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Kwan P, Lim SH, Chinvarun Y, Cabral-Lim L, Aziz ZA, Lo YK, Tonner F, Beh K, Edrich P; N01036 (SKATE II) Investigator Group. Efficacy and safety of levetiracetam as adjunctive therapy in adult patients with uncontrolled partial epilepsy: the Asia SKATE II Study. Epilepsy Behav. 2010 May;18(1-2):100-5. doi: 10.1016/j.yebeh.2010.03.016. Epub 2010 May 11.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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N01036
Identifier Type: -
Identifier Source: org_study_id
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