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A Double-Blind, Randomized, Placebo and Active Controlled Study to Evaluate the Efficacy and Safety of Once Daily, Extended Release Levetiracetam as Add-on Therapy in Patients with Refractory Partial Onset Epilepsy.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514499-42-00
Acronym
NXPLEVE/24/P3-6
Enrollment
134
Registered
2025-02-11
Start date
2025-03-12
Completion date
Unknown
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Partial Onset Epilepsy

Brief summary

Percent change from baseline* in FOS frequency per week over the 12 week double-blind period.

Detailed description

Change from baseline* in absolute FOS over the 12 week double-blind period., Proportion of subjects with at least 50% reduction from baseline* in total seizure frequency per week over the 12 week double-blind period., Proportion of subjects with at least 50% reduction from baseline* in total seizures over the 12 week double-blind period., Number of days free of FOS over the treatment period of 12 weeks., Response in Weekly FOS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks)., Change in the Quality of Life in Epilepsy (QoLIE-31) scale score (patients ≥18 years) and QoLIE- AD-48 (age <18 years) over the study period., Improving medication compliance and patient satisfaction with the treatment over the study period.

Interventions

DRUGKeppra 500 mg film-coated tablets
DRUGLevetiracetam prolonged-release placebo granules
DRUGMasked Keppra® placebo film-coated tablets (a placebo tablet inside a capsule)

Sponsors

Neuraxpharm Pharmaceuticals S.L.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percent change from baseline* in FOS frequency per week over the 12 week double-blind period.

Secondary

MeasureTime frame
Change from baseline* in absolute FOS over the 12 week double-blind period., Proportion of subjects with at least 50% reduction from baseline* in total seizure frequency per week over the 12 week double-blind period., Proportion of subjects with at least 50% reduction from baseline* in total seizures over the 12 week double-blind period., Number of days free of FOS over the treatment period of 12 weeks., Response in Weekly FOS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks)., Change in the Quality of Life in Epilepsy (QoLIE-31) scale score (patients ≥18 years) and QoLIE- AD-48 (age <18 years) over the study period., Improving medication compliance and patient satisfaction with the treatment over the study period.

Countries

Bulgaria, Czechia, Germany, Greece, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026