Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00490035
First received: June 21, 2007
Last updated: February 19, 2013
Last verified: February 2013
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Purpose
This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.
| Condition | Intervention | Phase |
|---|---|---|
|
Epilepsy |
Other: Placebo Drug: Brivaracetam |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Double-blind, Parallel-group, Placebo Controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures. |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Partial onset seizure (Type I) frequency per week over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Partial onset seizure (Type I) frequency per week over the 12-week Treatment Period
Secondary Outcome Measures:
- Responder rate for partial onset seizures (Type I) frequency per week over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Responder rate for partial onset seizures (Type I) frequency per week over the 12-week Treatment Period
- All seizure frequency (Type I+II+III) per week over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]All seizure frequency (Type I+II+III) per week over the 12-week Treatment Period
- Percent change from Baseline to the 12-week Treatment Period in partial onset seizure (Type I) frequency per week [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Percent change from Baseline to the 12-week Treatment Period in partial onset seizure (Type I) frequency per week
- Categorized percentage change from Baseline in seizure frequency for partial onset seizure (Type I)over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Categorized percentage change from Baseline in seizure frequency for partial onset seizure (Type I) over the 12-week Treatment Period
- Seizure freedom rate (all seizure types) over the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Seizure freedom rate (all seizure types) over the 12-week Treatment Period
- Time to first Type I seizure during the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Time to first Type I seizure during the 12-week Treatment Period
- Time to fifth Type I seizure during the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Time to fifth Type I seizure during the 12-week Treatment Period
- Time to tenth Type I seizure during the 12-week Treatment Period [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Time to tenth Type I seizure during the 12-week Treatment Period
- Reduction of Type IC/Type I seizure frequency ratio from Baseline to the 12- week Treatment Period. [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Reduction of Type IC/Type I seizure frequency ratio from Baseline to the 12- week Treatment Period.
- Change from Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Change from Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score
- Change from Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Change from Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score
- Change from Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Change from Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) score
- Change from Baseline to the 12-week Treatment Period in Hospital Anxiety score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Change from Baseline to the 12-week Treatment Period in Hospital Anxiety score
- Change from Baseline to the 12-week Treatment Period in Hospital Depression score [ Time Frame: Baseline to 12-week Treatment Period ] [ Designated as safety issue: No ]Change from Baseline to the 12-week Treatment Period in Hospital Depression score
- Patient's Global Evaluation Scale (P-GES) evaluated at last visit or early discontinuation visit [ Time Frame: Baseline to last visit or early discontinuation visit in the 12-week Treatment Period ] [ Designated as safety issue: No ]Patient's Global Evaluation Scale (P-GES) evaluated at last visit or early discontinuation visit
- Investigator's Global Evaluation Scale (I-GES) evaluated at last visit or early discontinuation visit [ Time Frame: Baseline to last visit or early discontinuation visit in the 12-week Treatment Period ] [ Designated as safety issue: No ]Investigator's Global Evaluation Scale (I-GES) evaluated at last visit or early discontinuation visit
| Enrollment: | 398 |
| Study Start Date: | September 2007 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Matching Placebo tablets administered twice a day
|
Other: Placebo
Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period
|
|
Experimental: Brivaracetam 20 mg/day
Brivaracetam 20 mg/day, 10 mg administered twice a day
|
Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period
|
|
Experimental: Brivaracetam 50 mg/day
Brivaracetam 50 mg/day, 25 mg administered twice a day
|
Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day in a double-blinded way for the 12-week Treatment Period.
|
|
Experimental: Brivaracetam 100 mg/day
Brivaracetam 100 mg/day, 50 mg administered twice a day
|
Drug: Brivaracetam
Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 100 mg /day in a double-blinded way for the 12-week Treatment Period.
|
Eligibility| Ages Eligible for Study: | 16 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
- Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
- Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
- Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1
- Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
- Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED
Exclusion Criteria:
- History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
- History or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490035
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| Belgium | |
| 13 | |
| Gent, Belgium | |
| 19 | |
| La Louviere, Belgium | |
| 12 | |
| Liege, Belgium | |
| 10 | |
| Saint-Vith, Belgium | |
| Finland | |
| 44 | |
| Kuopio, Finland | |
| 41 | |
| Oulu, Finland | |
| 42 | |
| Seinajoki, Finland | |
| 43 | |
| Tampere, Finland | |
| France | |
| 60 | |
| Angers Cedex 9, France | |
| 56 | |
| Bethune, France | |
| 62 | |
| Bron, France | |
| 57 | |
| Dijon, France | |
| 53 | |
| Lille, France | |
| 52 | |
| Montpellier Cedex, France | |
| 64 | |
| Nancy, France | |
| 54 | |
| Paris, France | |
| 51 | |
| Rennes, France | |
| 61 | |
| Roanne, France | |
| 55 | |
| Strasbourg, France | |
| Germany | |
| 76 | |
| Bad Berka, Germany | |
| 73 | |
| Berlin, Germany | |
| 79 | |
| Bernau, Germany | |
| 78 | |
| Bielefeld, Germany | |
| 74 | |
| Freiburg, Germany | |
| 75 | |
| Kehl-Kork, Germany | |
| 77 | |
| Mainz, Germany | |
| 70 | |
| Munchen, Germany | |
| 72 | |
| Radeberg, Germany | |
| 71 | |
| Ulm, Germany | |
| Hungary | |
| 94 | |
| Budapest, Hungary | |
| 90 | |
| Debrecen, Hungary | |
| 92 | |
| Pecs, Hungary | |
| India | |
| 256 | |
| Bangalore, India | |
| 257 | |
| Bangalore, India | |
| 253 | |
| Hyderabad, India | |
| 258 | |
| Jaipur, India | |
| 255 | |
| Kolkata, India | |
| 250 | |
| Lucknow, India | |
| 259 | |
| Mumbai, India | |
| 270 | |
| Pune, India | |
| 251 | |
| Pune Maharashtra, India | |
| Italy | |
| 104 | |
| Bologna, Italy | |
| 105 | |
| Foggia, Italy | |
| 101 | |
| Perugia, Italy | |
| 103 | |
| Roma, Italy | |
| 107 | |
| Roma, Italy | |
| Netherlands | |
| 124 | |
| Breda, Netherlands | |
| 125 | |
| Den Haag, Netherlands | |
| 122 | |
| Zwolle, Netherlands | |
| Poland | |
| 142 | |
| Bialystok, Poland | |
| 143 | |
| Gdansk, Poland | |
| 153 | |
| Grodzisk Mazowiecki, Poland | |
| 151 | |
| Katowice, Poland | |
| 147 | |
| Katowice, Poland | |
| 141 | |
| Kielce, Poland | |
| 150 | |
| Krakow, Poland | |
| 148 | |
| Lodz, Poland | |
| 144 | |
| Lublin, Poland | |
| 152 | |
| Poznan, Poland | |
| 146 | |
| Szczecin, Poland | |
| 145 | |
| Warsaw, Poland | |
| 149 | |
| Warszawa, Poland | |
| 140 | |
| Warszawa, Poland | |
| Spain | |
| 187 | |
| Alcorcon, Spain | |
| 181 | |
| Barcelona, Spain | |
| 182 | |
| Madrid, Spain | |
| 184 | |
| San Sebastian, Spain | |
| 183 | |
| Vigo, Spain | |
| 185 | |
| Zaragoza, Spain | |
| Switzerland | |
| 201 | |
| Biel, Switzerland | |
| 205 | |
| Geneve, Switzerland | |
| 203 | |
| St Gallen, Switzerland | |
| 202 | |
| Tschugg, Switzerland | |
| 204 | |
| Zürich, Switzerland | |
| United Kingdom | |
| 223 | |
| Liverpool, United Kingdom | |
| 224 | |
| Middlesborough, United Kingdom | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00490035 History of Changes |
| Other Study ID Numbers: | N01252, 2006-006344-59 |
| Study First Received: | June 21, 2007 |
| Last Updated: | February 19, 2013 |
| Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Netherlands: Medicines Evaluation Board (MEB) Poland: Ministry of Health Switzerland: Swissmedic Hungary: National Institute of Pharmacy India: Drugs Controller General of India |
Keywords provided by UCB, Inc.:
|
Epilepsy Brivaracetam Partial Onset Seizures |
Additional relevant MeSH terms:
|
Epilepsy Seizures Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013