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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

Inclusion Criteria:

• Male/female adult subjects (≥ 16 or 18 years)

• Diagnosis of epilepsy (all types of seizures may be included)

• Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy

Other inclusion criteria may apply

Exclusion Criteria:

• Subjects withdrawn from N01175 (NCT00175903) trial for any reason

• 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