Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.
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|ClinicalTrials.gov Identifier: NCT00150787|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : November 26, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Epilepsy, Tonic-clonic||Drug: LEVETIRACETAM||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Double-blind, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam (1000 to 3000 mg/Day Oral b.i.d.) and Carbamazepine (400 to 1200 mg/Day Oral b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Coming From the N01061 Trial.|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||November 2005|
- Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs
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|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
- Subjects with a confirmed diagnosis of epilepsy.
- Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin), or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
- Subjects coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.
- Need for an additional AED.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150787
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|
|Other Study ID Numbers:||
|First Posted:||September 8, 2005 Key Record Dates|
|Last Update Posted:||November 26, 2013|
|Last Verified:||September 2009|
Central Nervous System Diseases
Nervous System Diseases