Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy



Status:Active, not recruiting
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:16 - Any
Updated:3/27/2019
Start Date:May 11, 2011
End Date:March 2019

Use our guide to learn which trials are right for you!

An Open-label, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects Aged 16 Years or Older With Epilepsy

This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and
single arm study of brivaracetam (BRV).

The primary objective is to evaluate the long term safety and tolerability of BRV at
individualized doses up to a maximum of 200 mg/day in epilepsy subjects.

Inclusion Criteria:

- Subject completed the Treatment Period of N01358 or the evaluation period of N01258

- Male/female subject from 16 years or older. Subject under 18 years may only be
included where legally permitted and ethically accepted

- Subject for whom the Investigator believes a reasonable benefit from the long term
administration of BRV may be expected

- Female subject without childbearing potential (premenarcheal, postmenopausal for at
least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are
eligible

Exclusion Criteria:

- Subject has developed hypersensitivity to any components of the investigational
medicinal product (IMP) or comparative drugs as stated in this protocol during the
course of the core studies

- Severe medical, neurological, or 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 BRV study

- Planned participation in any other clinical study of another investigational drug or
device during this study

- Pregnant or lactating woman

- Any medical condition which, in the Investigator's opinion, warrants exclusion

- Subject has a lifetime history of suicide attempt or has suicidal ideation in the past
6 months
We found this trial at
44
sites
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
?
mi
from
Ames, IA
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Boise, ID
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
?
mi
from
Golden Valley, MN
Click here to add this to my saved trials
?
mi
from
Hamilton, NJ
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Innsbruck,
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Mansfield, TX
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
Port Royal, South Carolina 29935
?
mi
from
Port Royal, SC
Click here to add this to my saved trials
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials
?
mi
from
Rome, GA
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Waldorf, MD
Click here to add this to my saved trials
?
mi
from
Winfield, IL
Click here to add this to my saved trials