Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV)
Completed · Phase 3
Conditions studied: Epilepsy
In brief
Trial N01395 is to evaluate the reduction of nonpsychotic behavioral side effects in subjects with Epilepsy who switched to BRV 200 mg/day after discontinuing LEV due to such side effects; as well as the efficacy, safety and tolerability of BRV. No statistical hypothesis testing will be performed.
Key facts
- Study ID
- NCT01653262
- Run by
- UCB Pharma SA
- People needed
- 29
- Starts
- 2012-07-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2018-07-11
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject with well-characterized Epilepsy according to the 1989 International League Against Epilepsy (ILAE) classification
- 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
You may not qualify if…
- Subject has a lifetime history of suicide attempt (including an actual, interrupted or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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