Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
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| ClinicalTrials.gov Identifier: NCT00175916 |
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Recruitment Status :
Completed
First Posted : September 15, 2005
Results First Posted : July 16, 2020
Last Update Posted : August 17, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Drug: Brivaracetam (ucb 34714) | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 853 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy |
| Actual Study Start Date : | September 2005 |
| Actual Primary Completion Date : | May 2019 |
| Actual Study Completion Date : | May 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Brivaracetam
Flexible dosing, can up and down titrate as needed.
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Drug: Brivaracetam (ucb 34714)
10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures; or until the Sponsor decides to close the study; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor. |
- Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
- Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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].
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175916
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| Study Director: | UCB Cares | +1 844 599 2273 (UCB) |
Documents provided by UCB Pharma:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00175916 |
| Other Study ID Numbers: |
N01125 2004-002140-10 ( EudraCT Number ) |
| First Posted: | September 15, 2005 Key Record Dates |
| Results First Posted: | July 16, 2020 |
| Last Update Posted: | August 17, 2021 |
| Last Verified: | August 2021 |
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Brivaracetam Epilepsy long term |
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Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Brivaracetam Anticonvulsants |