NCT00291655

Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe. To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Levetiracetam	500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-02-14
• Last updated: 2015-05-18
• Results posted: 2009-11-13

Locations

35 sites across 6 countries: Belgium, Bulgaria, Finland, France, Poland, Switzerland