Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy

NCT ID: NCT01728077

Last Updated: 2018-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-08-31

Brief Summary

N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.

Detailed Description

Flexible dosing up to 200 mg/day, twice daily (10, 25 and 50 mg oral film-coated tablets). The study will continue until either regulatory approval of BRV has been granted by any Health Authority in an indication of adjunctive treatment of Epilepsy, or until the Sponsor decides to close the study, or until the BRV development is stopped by the Sponsor.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brivaracetam

At Entry Visit (EV), subjects will start on the individualized Brivaracetam (BRV) dose that they had reached at the completion of the previous study. Dose adjustments of the Investigational Medicinal Product (IMP) are allowed at any time based on the clinical judgment of the investigator. The BRV dose can be increased or decreased in increments of 50 mg/day based on the individual subject's seizure control and/or tolerability; however, the BRV dose should not exceed 200 mg/day during the study and must always be administered as a symmetrical morning and evening dose. Upon completion or early discontinuation from this study, there will be a Down-Titration Period in steps of 50 mg/day on a weekly basis until 20 mg/day for 1 week is reached, followed by a Post-Treatment Period (between 2 and 4 weeks) during which the subject will not receive study drug. No down-Titration Period will be applicable if subjects are continued on BRV after they complete this study.

Group Type: EXPERIMENTAL

Brivaracetam

Intervention Type: DRUG

Flexible dosing, can up and down-titrate as needed.

Interventions

Brivaracetam

Flexible dosing, can up and down-titrate as needed.

Intervention Type: DRUG

Other Intervention Names

UCB34714

Eligibility Criteria

Inclusion Criteria

• Subject is male or female and 16 years or older. Subjects under 18 years of age may be included only where legally permitted and ethically accepted
• Subjects having completed the Treatment Period of an applicable previous BRV study, and have access to the present study
• Subject for whom the investigator believes a reasonable benefit from the long-term administration of BRV may be expected
• Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
• Subjects must be able to take the oral film-coated tablets of BRV

Exclusion Criteria

• Subject has developed hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs as stated in the protocol during the course of the prior study
• Severe medical, neurological, or psychiatric disorders, or laboratory values that 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 (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either question 4 or question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the last visit of the previous study or at the Entry Visit of this study if not completed at the last visit of the previous study

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

103

Little Rock, Arkansas, United States

108

Lexington, Kentucky, United States

109

New York, New York, United States

106

Akron, Ohio, United States

110

Dallas, Texas, United States

102

Salt Lake City, Utah, United States

201

Paris, , France

303

Bernau, , Germany

300

Kehl-Kork, , Germany

502

Seville, , Spain

Countries

United States; France; Germany; Spain

References

Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.

Reference Type: DERIVED

PMID: 26899665 (View on PubMed)

Related Links

https://www.briviact.com/briviact-PI.pdf?v=1479491757

Product Information

http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

2012-000827-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N01372

Identifier Type: -

Identifier Source: org_study_id