A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

  • STATUS
    Recruiting
  • End date
    Jul 4, 2022
  • participants needed
    444
  • sponsor
    UCB Biopharma SRL
Updated on 16 June 2021
Investigator
UCB Cares
Primary Contact
Ep0083 126 (0.0 mi away) Contact
+105 other location
adjunctive treatment
seizure
antiepileptics
vagus nerve stimulation
brivaracetam
partial seizure

Summary

The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects >= 16 years to 80 years of age.

Details
Condition Epilepsy, Seizure Disorders (Pediatric), Partial Seizures With or Without Secondary Generalization, Seizure Disorders, epileptic, seizure disorder, epilepsia, epileptics
Treatment Placebo, Brivaracetam
Clinical Study IdentifierNCT03083665
SponsorUCB Biopharma SRL
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive
Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period
Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED

Exclusion Criteria

Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Subject is currently treated with levetiracetam
Subject has taken levetiracetam within 90 days prior to Visit 1
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note