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.

UCB

Status and phase

Withdrawn

Phase 3

Conditions

Epilepsy

Treatments

Drug: Seletracetam (ucb 44212)

Study type

Interventional

Funder types

Industry

Identifiers

Not yet available

N01212

Details and patient eligibility

About

This is a safety and efficacy study of add on therapy with seletracetam in patients experiencing refractory epilepsy.

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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.