Phase 3 Completed N=26 Treatment

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

Source: ClinicalTrials.gov NCT01728077 ↗

Enrolled (actual)

Serious AEs

26.9%

Results posted

Aug 2017

Primary outcomePrimary: Incidence of Treatment Emergent Adverse Events (TEAEs) During Evaluation Period — 78.9; 71.4 percentage of subjects

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Treatment Emergent Adverse Events (TEAEs) During Evaluation Period	78.9; 71.4	—
PRIMARY Percentage of Subjects Withdrawn Due to an Adverse Event (AE) During the Evaluation Period	0; 14.3	—
PRIMARY Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period	26.3; 28.6	—
SECONDARY Frequency of Partial-Onset Seizure (POS) Type I Per 28 Days During the Evaluation Period for Subjects With Focal-onset Epilepsy	0.4	—
SECONDARY 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	-56.3	—
SECONDARY 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	54.5	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01728077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.