Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures

Completed · Phase 2

Conditions studied: Epilepsy, Partial

In brief

This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.

Key facts

Study ID

NCT00152451

Run by

UCB S.A. - Pharma Sector

People needed

31

Starts

2005-05-19

Expected to finish

2006-05-03

Last updated by the study team

2024-03-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)
• Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures whether or not secondarily generalized
• Subjects who have been treated for epilepsy for >=6 months and are currently uncontrolled while being treated with 1-3 concomitant Antiepileptic Drug (AEDs)
• Female subjects without childbearing potential; Female subjects with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method

You may not qualify if…

• Seizures occurring in clusters.
• Status epilepticus within 6 months of Visit 1
• History of non-epileptic seizures
• Subjects on vigabatrin
• Subjects on felbamate, unless treatment has been continuous for >2 years
• Ongoing psychiatric disease other than mild controlled disorders.
• Subjects with clinically significant organ dysfunction
• Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
• Pregnant or lactating women
• Subjects currently taking levetiracetam (LEV)
• 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 Antiepileptic Drug (AEDs)

Where it is running

• N01191 108 — Little Rock, Arkansas, United States
• N01191 105 — San Francisco, California, United States
• N01191 102 — Stanford, California, United States
• N01191 107 — Columbus, Ohio, United States
• N01191 104 — Philadelphia, Pennsylvania, United States
• N01191 101 — Nashville, Tennessee, United States
• N01191 103 — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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