Open Label Study (Everyone Who Participates Receives Drug) to Further Determine How Safe and Effective Oral Treatment of Seletracetam is in Patients With Refractory Epilepsy.

Open Label, Multicenter Study of the Safety and Efficacy of Oral Treatment With Immediate Release Seletracetam (Ucb 44212) at Individualized Doses up to a Maximum of 160mg/Day in Refractory Epileptic Patients.

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00175864

Enrollment

Registered

2005-09-15

Start date

2006-02-28

Completion date

Unknown

Last updated

2012-03-20

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 patients experiencing refractory epilepsy.

Interventions

DRUGSeletracetam (ucb 44212)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Inclusion criteria

* An IRB/IEC approved written informed consent form signed and dated Male/Female patients age 18 (or 16 years where permitted by law) to 65. * Minimum body weight of 40 kg. * Patients with a confirmed diagnosis of refractory epilepsy of ≥ 6 months. * Patients must be receiving 1 - 3 concomitant AEDs. * Female patients without childbearing potentials (2 years post-menopausal or surgical sterilization) are eligible. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method.

Exclusion criteria

* Seizures occurring in clusters (seizures occurring either too frequently or indistinctly separated to be reliably counted). * Status epilepticus within 3 months of Visit 1. * History of non-epileptic seizures. * Patients on vigabatrin. * Patients on felbamate, unless treatment has been continuous for ≥ 18 months. * Use of benzodiazepines (for any indication) taken at a higher frequency than an average of once a week, unless counted as one of the concomitant AEDs. * Ongoing psychiatric disease other than mild controlled disorders. * Patients with a clinically significant organ dysfunction. * Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients. * Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control.

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