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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00291655

N01237

EUDRACT NUMBER: 2006-000173-29

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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• Subjects withdrawn from N01175 (NCT00175903) trial for any reason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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

Levetiracetam (LEV)

Experimental group

Treatment:

Drug: Levetiracetam