Phase 3 Completed N=130 Treatment

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

Epilepsy

Source: ClinicalTrials.gov NCT00291655 ↗

Enrolled (actual)

130

Serious AEs

4.6%

Results posted

Nov 2009

Primary outcomePrimary: Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase — 40; 8; 1; 16 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase	40; 8; 1; 16; 4; 6	—
SECONDARY Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months	0.71	—

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Subjects withdrawn from N01175 (NCT00175903) trial for any reason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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00291655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.