Phase 3
Completed N=667
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
Source: ClinicalTrials.gov NCT00150800 ↗Enrolled (actual)
667
Serious AEs
22.8%
Results posted
Dec 2018
Primary outcomePrimary: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period — 91.2 percentage of participants
Summary
This trial, evaluating the long-term safety and tolerability of brivaracetam will provide subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive treatment, the opportunity to receive open label brivaracetam treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) During the Study Period |
91.2 | — |
| PRIMARY Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Period |
14.8 | — |
| PRIMARY Percentage of Participants With a Serious Adverse Event (SAE) During the Study Period |
22.8 | — |
| SECONDARY Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period |
9.2; 4.2 | — |
| SECONDARY Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period |
57.3 | — |
| SECONDARY Percentage of Participants With Response for Partial Onset Seizure (POS) (Type I) Frequency Over the Evaluation Period |
55.6 | — |
Eligibility Criteria
Inclusion Criteria
- Male/ female subjects from 16 years and on. Subjects under 18 years may only be included where legally permitted and ethically accepted
- Subjects with epilepsy who have participated in previous brivaracetam trials which allow access to the present study
- Subjects for whom the investigator believes a reasonable benefit from the long term administration of brivaracetam may be expected
- Female subjects without childbearing potential. Female subjects with child bearing potential are eligible if they use a medically accepted contraceptive method for the duration of the study
- Subject/ legally acceptable representative considered as reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the Investigator
Exclusion Criteria
- Severe medical, neurological and 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 brivaracetam study
- Pregnant or lactating women
- Participation in any clinical study of another investigational drug or device during the study
Data sourced from ClinicalTrials.gov (NCT00150800). 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.