Open Label Trial to Study the Long-term Safety and Efficacy of Seletracetam for the Treatment of Epilepsy

An Open-label, Multicenter, Follow-up Trial to Evaluate the Long-term Safety and Efficacy of Seletracetam Used as Adjunctive Treatment Using a Flexible Dosing Scheme of 4 to 80 mg b.i.d. in Subjects Aged 16 Years or Older Suffering From Epilepsy

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00175851

Enrollment

Registered

2005-09-15

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

Epilepsy

Keywords

Partial onset, primary generalized seizures, seletracetam

Brief summary

This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study

Interventions

DRUGSeletracetam (ucb 44212)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Inclusion criteria

* A signed and dated IRB/IEC approved written informed consent form * Male/female age 18 years (16 years where permitted) to 65 years * Minimum body weight of 40 kg * Patients having participated in a previous seletracetam study * Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.

Exclusion criteria

* Ongoing psychiatric disease other than mild controlled disorders * Subject with clinically significant abnormalities in laboratory tests or ECG * Poor compliance with visit schedule or medication intake in a previous seletracetam study * Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment

Design outcomes

Primary

Measure	Time frame
Safety profile of seletracetam	—

Secondary

Measure	Time frame
Reduction in seizure frequency	—

Outcome results

None listed

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