Clinical trial NCT01728077: Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy
Official title: 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 Phase 3b
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Brivaracetam
Long-term Follow-up
Epilepsy
Partial Onset Seizures
Adjunctive treatment
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 26
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Incidence of Treatment Emergent Adverse Events (TEAEs) During Evaluation Period
timeFrame: From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
measure: Percentage of Subjects Withdrawn Due to an Adverse Event (AE) During the Evaluation Period
timeFrame: From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
measure: Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period
timeFrame: From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
Secondary outcomes:
measure: Frequency of Partial-Onset Seizure (POS) Type I Per 28 Days During the Evaluation Period for Subjects With Focal-onset Epilepsy
timeFrame: From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
measure: Percentage of Change in Partial-Onset-Seizure (POS) Type I Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected
timeFrame: From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)
measure: 50 % Responder Rate in Partial-Onset-Seizure (POS) Type I Frequency From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected
timeFrame: From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: 103
state: Arkansas
city: Lexington
country: United States
facility: 108
state: Kentucky
city: New York
country: United States
facility: 109
state: New York
city: Akron
country: United States
facility: 106
state: Ohio
city: Dallas
country: United States
facility: 110
state: Texas
city: Salt Lake City
country: United States
facility: 102
state: Utah
city: Paris
country: France
facility: 201
city: Bernau
country: Germany
facility: 303
city: Kehl-Kork
country: Germany
facility: 300
city: Sevilla
country: Spain
facility: 502
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.