CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 130 enrolled
Drug / intervention
Levetiracetamdrug
Likely dose
Levetiracetam 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00291655
NCT00291655Phase 3Completed
CompareCT.gov

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).

UCB Pharma·interventional·Posted Feb 14, 2006·Updated May 18, 2015

In Brief

A Phase 3 clinical trial evaluating Levetiracetam for Epilepsy. Completed, enrolled 130 participants across 35 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBelgium, Bulgaria, Finland, France, Poland, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2006
Enrollment StartJun 1, 2006
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.4 years ago

Interventions

Levetiracetamdrug

500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study