Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
- Registration Number
- NCT00175916
- Lead Sponsor
- UCB Pharma
- Brief Summary
This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 853
- Male/female subjects from 16 years (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study
- Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study
- Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs 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
- Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
- Poor compliance with visit schedule or medication intake in previous brivaracetam study
- Participation in any clinical study of another investigational drug or device during the study
- Pregnant or lactating woman
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brivaracetam Brivaracetam (ucb 34714) Flexible dosing, can up and down titrate as needed.
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Entry Visit until Last Visit (up to 162 months) Treatment-emergent adverse events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) From Entry Visit until Last Visit (up to 162 months) An AE is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants With at Least One Serious Adverse Event (SAE) From Entry Visit until Last Visit (up to 162 months) A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
* Results in death
* Is life-threatening
* Requires in patient hospitalization or prolongation of existing hospitalization
* Is a congenital anomaly or birth defect
* Is an infection that requires treatment parenteral antibiotics
* Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
- Secondary Outcome Measures
Name Time Method Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period From Entry Visit until Last Visit (up to 162 months) The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.
Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 \[NCT00175929\], N01252 \[NCT00490035\] and N01254 \[NCT00504881\].Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period From Entry Visit until Last Visit (up to 162 months) The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:
(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.
Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 \[NCT00175929\], N01252 \[NCT00490035\] and N01254 \[NCT00504881\].Responder Rate in POS (Type I) Frequency Over the Evaluation Period From Entry Visit until Last Visit (up to 162 months) A responder is defined as a participant with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study.
Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 \[NCT00175929\], N01252 \[NCT00490035\] and N01254 \[NCT00504881\].
Trial Locations
- Locations (153)
935
🇺🇸San Francisco, California, United States
933
🇺🇸Gainesville, Florida, United States
931
🇺🇸Charlottesville, Virginia, United States
509
🇦🇹Graz, Austria
507
🇦🇹Innsbruck, Austria
510
🇦🇹Linz, Austria
508
🇦🇹Wien, Austria
501
🇧🇪Edegem, Antwerpen, Belgium
515
🇧🇪Montignies sur Sambre, Chaleroi, Belgium
506
🇧🇪Brugge, Belgium
Scroll for more (143 remaining)935🇺🇸San Francisco, California, United States