Levetiracetam
DrugDaily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
NCT Number: NCT00175903
Study N01175 was to compare overall effectiveness (efficacy and safety) of levetiracetam (LEV) versus the 2 older antiepileptic drugs (AEDs), sodium valproate extended release (VPA-ER) and carbamazepine controlled release (CBZ-CR) in the treatment of subjects with newly diagnosed epilepsy.
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Notify Me16 year and older
All sexes
Interventional
Phase 3
Adelaide, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Daily dose of 1000 to 3000 mg film-coated oral tablets, 250-500 mg twice daily.
Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.
Daily dose of 1000-2000 mg ER oral tablets, 300 mg and 500 mg twice daily.
Time frame: Visit 1 to End of Study (approximately 52 weeks)
Time frame: Visit 1 to End of Study (approximately 52 weeks)
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
Time frame: Visit 1 to Visit 4 (approximately 26 weeks)
Time frame: Visit 1 to Visit 5 (approximately 52 weeks)
Time frame: Visit 1 to End of Study (approximately 52 weeks)
Time frame: Visit 1 to End of Study (approximately 52 weeks)
UCB Pharma
Industry
A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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