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



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:16 - Any
Updated:12/7/2018
Start Date:January 2006
End Date:September 2017

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An Open-label, Multi-center, Follow-up Trial to Evaluate Long Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy

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.

Study access was limited to subjects having completed one of the previous brivaracetam (BRV)
studies: N01193 [NCT00175825], N01252 [NCT00490035], N01253 [NCT00464269], N01254
[NCT00504881].

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
47
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Chicago, Illinois
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Atlanta, Georgia
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Augusta, Georgia
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1373 Maryland Avenue
Baltimore, Maryland 21201
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Bethesda, Maryland 20814
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Bethesda, MD
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1077 Massachusetts Avenue
Burlington, Massachusetts 02420
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Burlington, MA
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Charlottesville, Virginia
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Chatswood, New South Wales 2067
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Chesterfield, Missouri
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Chesterfield, MO
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1366 Ohio River Scenic Byway
Cincinnati, Ohio 45202
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Cincinnati, OH
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1054 South Ohio Avenue
Columbus, Ohio 43206
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Columbus, OH
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1084 Texas Circle
Dallas, Texas 75182
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Dallas, Texas
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1391 Michigan Avenue
Detroit, Michigan 48226
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1395 Michigan Avenue
Detroit, Michigan 48226
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Detroit, MI
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1078 West California Avenue
Fresno, California 93706
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Grand Rapids, Michigan
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Grand Rapids, MI
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Great Falls, Montana
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2 Exchange Street
Greenville, South Carolina 29605
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Houston, Texas
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Houston, TX
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1364 Lexington Road
Lexington, Kentucky 40422
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Lexington, KY
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1050 Arkansas River Trail
Little Rock, Arkansas 72201
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Little Rock, AR
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1380 West Kentucky Street
Louisville, Kentucky 40210
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1369 West Wisconsin Avenue
Milwaukee, Wisconsin 53233
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Milwaukee, WI
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1061 Tennessee 6
Nashville, Tennessee 37203
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1053 New York Avenue
New York, New York 11203
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1392 California 1
Newport Beach, California 92660
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1052 Kentucky Avenue
Paducah, Kentucky 42003
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1055 East Pennsylvania Boulevard
Philadelphia, Pennsylvania 19053
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1059 East Pennsylvania Boulevard
Philadelphia, Pennsylvania 19053
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1051 East Phoenix Street
Phoenix, Arizona 85541
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1362 Phoenix Bypass Route
Phoenix, Arizona 85337
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1359 Portland Street
Portland, Oregon 43616
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1393 Virginia Avenue
Richmond, Virginia 94804
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Richmond, VA
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1365 Rochester Avenue
Rochester, New York 11213
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Rochester, NY
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1083 West Louisiana Avenue
Ruston, Louisiana 71270
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1352 Lake Saint Louis Boulevard
Saint Louis, Missouri 63367
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1389 Minnesota 5
Saint Paul, Minnesota 55102
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Salt Lake City, Utah
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1087 California Street
San Francisco, California 94108
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1368 California Street
San Francisco, California 94109
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1376 South Washington Street
Seattle, Washington 98144
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Springfield, Illinois
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Toms River, New Jersey
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1374 West Cll Arizona
Tucson, Arizona 85705
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Tupelo, Mississippi
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1375 South Kansas Street
Wichita, Kansas 67211
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