Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)
NCT ID: NCT01653262
Last Updated: 2018-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
29 participants
INTERVENTIONAL
2012-07-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brivaracetam
The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.
Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.
At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks.
Brivaracetam
Interventions
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Brivaracetam
Eligibility Criteria
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Inclusion Criteria
* Subject with Epilepsy who the investigator expects will benefit from Levetiracetam (LEV) but for whom the investigator has decided to discontinue due to nonpsychotic behavioral side effects following the introduction of LEV
* Subject is currently receiving LEV at the recommended therapeutic dose (dose ranging from 1 g/day to 3 g/day)
* Subject currently treated with minimum 2 and maximum 3 Anti-Epileptic Drugs (AEDs) including LEV. Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
* 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
Exclusion Criteria
* Subject whose seizures could not be reliably counted on a regular basis due to their fast and repetitive occurrence (clusters or flurries)
* Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
* Subject has history or presence of known psychogenic nonepileptic seizures
* Subject has any clinical conditions (eg, bone marrow depression, chronic hepatic disease, and/or severe renal impairment) which impair reliable participation in the study or necessitate the use of medication not allowed by protocol
* Subject is pregnant or lactating
16 Years
ALL
No
Sponsors
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UCB Pharma SA
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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103
Little Rock, Arkansas, United States
108
Lexington, Kentucky, United States
109
New York, New York, United States
106
Akron, Ohio, United States
110
Dallas, Texas, United States
102
Salt Lake City, Utah, United States
203
Amiens, , France
201
Paris, , France
303
Bernau, , Germany
300
Kehl-Kork, , Germany
502
Seville, , Spain
603
Salford, , United Kingdom
Countries
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References
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Yates SL, Fakhoury T, Liang W, Eckhardt K, Borghs S, D'Souza J. An open-label, prospective, exploratory study of patients with epilepsy switching from levetiracetam to brivaracetam. Epilepsy Behav. 2015 Nov;52(Pt A):165-8. doi: 10.1016/j.yebeh.2015.09.005. Epub 2015 Sep 29.
Other Identifiers
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2011-005177-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01395
Identifier Type: -
Identifier Source: org_study_id
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