This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment

Completed · Phase 3

Conditions studied: Epilepsy

In brief

This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.

Key facts

Study ID

NCT00150800

Run by

UCB PHARMA Inc. (US)

People needed

668

Starts

2006-01-01

Expected to finish

2017-09-01

Last updated by the study team

2021-08-17

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
• Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
• Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
• Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
• Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator

You may not qualify if…

• Severe medical, neurological and psychiatric disorders or laboratory values which may have an impact on the safety of the subject
• Poor compliance with the visit schedule or medication intake in the previous brivaracetam study
• Pregnant or lactating women
• Participation in any clinical study of another investigational drug or device during the study

Where it is running

• N01199 1380 — Louisville, Kentucky, United States
• N01199 1052 — Paducah, Kentucky, United States
• N01199 1083 — Ruston, Louisiana, United States
• N01199 1373 — Baltimore, Maryland, United States
• N01199 1086 — Bethesda, Maryland, United States
• N01199 1077 — Burlington, Massachusetts, United States
• N01199 1391 — Detroit, Michigan, United States
• N01199 1395 — Detroit, Michigan, United States
• N01199 1071 — Grand Rapids, Michigan, United States
• N01199 1389 — Saint Paul, Minnesota, United States
• N01199 1079 — Tupelo, Mississippi, United States
• N01199 1360 — Chesterfield, Missouri, United States
• N01199 1352 — St Louis, Missouri, United States
• N01199 1069 — Great Falls, Montana, United States
• N01199 1062 — Toms River, New Jersey, United States
• N01199 1053 — New York, New York, United States
• N01199 1365 — Rochester, New York, United States
• N01199 1366 — Cincinnati, Ohio, United States
• N01199 1054 — Columbus, Ohio, United States
• N01199 1359 — Portland, Oregon, United States
• N01199 1055 — Philadelphia, Pennsylvania, United States
• N01199 1059 — Philadelphia, Pennsylvania, United States
• N01199 1081 — Greenville, South Carolina, United States
• N01199 1061 — Nashville, Tennessee, United States
• N01199 1364 — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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