A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures

A Phase IIb/III, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Seletracetam as Adjunctive Treatment in Subjects (≥16 to 70 Years Old) With Refractory Partial Onset Seizures.

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00422110

Enrollment

Registered

2007-01-15

Start date

2008-05-31

Completion date

Unknown

Last updated

2012-05-28

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

Conditions

Epilepsies, Partial

Keywords

Seletracetam, Epilepsies, Partial, Epilepsy, Focal

Brief summary

This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.

Interventions

DRUGSeletracetam

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Subjects from 16 to 70 years old * Confirmed diagnosis of focal epilepsy * Partial seizures uncontrolled while taking 1 or 2 AEDs * At least 8 partial seizures during the 8-week baseline period

Exclusion criteria

* Seizures occurring only in clusters * Status epilepticus within 1 year * Progressive CNS disorder * Other serious or uncontrolled diseases

Design outcomes

Primary

Measure	Time frame
Evaluate the efficacy of seletracetam compared to placebo in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite treatment with 1 - 2 concomittant AEDs	—

Secondary

Measure	Time frame
Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026