Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).
NCT ID: NCT00291655
Last Updated: 2015-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
130 participants
INTERVENTIONAL
2006-06-30
2008-04-30
Brief Summary
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To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levetiracetam (LEV)
Levetiracetam
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
Interventions
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Levetiracetam
500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of epilepsy (all types of seizures may be included)
* Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy
Exclusion Criteria
* Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial
* Subject requiring add-on antiepileptic treatment
* Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment
* Sexually active woman with childbearing potential who is not using a medically accepted birth control method
16 Years
ALL
No
Sponsors
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UCB Pharma
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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Bruges, , Belgium
Edegem, , Belgium
Ghent, , Belgium
Haine-Saint-Paul, , Belgium
Jette, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Ostend, , Belgium
Sofia, , Bulgaria
Varna, , Bulgaria
Hus (helsinki), , Finland
Kuopio, , Finland
Tampere, , Finland
Blaye, , France
Bordeaux, , France
Brest, , France
Carcassonne, , France
Cherbourg, , France
Lille, , France
Lyon, , France
Nancy, , France
Rennes, , France
Saint-Brieuc, , France
Saint-Quentin, , France
Toulouse, , France
Valenciennes, , France
Częstochowa, , Poland
Krakow, , Poland
Olsztyn, , Poland
Poznan, , Poland
Warsaw, , Poland
Biel, , Switzerland
Lausanne, , Switzerland
Sankt Gallen, , Switzerland
Zurich, , Switzerland
Countries
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Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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EUDRACT NUMBER: 2006-000173-29
Identifier Type: -
Identifier Source: secondary_id
N01237
Identifier Type: -
Identifier Source: org_study_id
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