Status:
COMPLETED
Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
16-70 years
Phase:
PHASE3
Brief Summary
This is a multicenter, open-label, 4-arm, randomized, parallel-group study to evaluate safety and tolerability of Brivaracetam Intravenous (BRV iv) as adjunctive treatment for adults with epilepsy acc...
Detailed Description
Eligible subjects will be randomized in a 1:1:1:1 ratio to the 4 treatment arms
Eligibility Criteria
Inclusion
- An Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved written Informed Consent form signed and dated by the subject or by parent(s) or legal representative
- Subjects from 16 to 70 years
- Subjects with a body weight of \>/= 40 kg
- Female subjects without childbearing potential or female subjects with childbearing potential if they use a medically accepted contraceptive method
- Subject/legal representative considered as reliable and capable of adhering to the protocol
- Subjects with well-characterized focal or generalized epilepsy or epileptic syndrome
- Subjects with a history of partial-onset seizures whether or not secondarily generalized or primary generalized seizures
- Subjects being uncontrolled while treated with 1 to 2 permitted concomitant antiepileptic drugs (AEDs)
- Permitted concomitant antiepileptic drugs (AEDs) and vagus nerve stimulation (VNS) being stable and at optimal dosage for the subject from at least 1 month before Visit 1 and expected to be kept stable during the Run-In and Evaluation Periods
Exclusion
- Mentally impaired subjects unable to understand the study purpose
- History or presence of status epilepticus during 1 year preceding Visit 1 or Baseline
- Subjects on felbamate with less than 18 months continuous exposure before Visit 1
- Subjects currently on vigabatrin
- Subject taking any drug with possible relevant central nervous system effects except is stable from at least 1 month before Visit 1 and expected to be kept stable during the trial
- Subjects taking any drug that may significantly influence the metabolism of Brivaracetam (BRV) except if the dose has been kept stable at least 1 month before Visit 1, and is expected to be kept stable during the trial
- History of cerebrovascular accident in the last 6 months
- Subjects suffering from severe cardiovascular disease or peripheral vascular disease
- Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
- Any clinical conditions which impair reliable participation in the study or necessitate the use of medication not allowed by protocol
- Presence of a terminal illness
- Presence of a serious infection
- Subjects with a history of sever adverse hematologic reaction to any drug
- Subjects suffering from severe disturbance of hemostasis
- Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) values of more than 3 times the upper limit of the reference range
- Subjects having clinically significant deviations from reference range values for laboratory parameters: creatinine clearance calculated \< 50 ml / min, platelets \< 100,000 / µL, or neutrophil cells \< 1,800 / µL
- Clinically significant electrocardiogram (ECG) abnormalities according to the Investigator
- History of suicide attempt
- In the Investigator's medical judgment, any current suicidal ideation or other serious psychiatric disorders requiring of having required hospitalization or medication
- Known allergic reaction or intolerance to pyrrolidone derivatives and / or investigational product excipients
- Known multiple drug allergies or severe drug allergy
- Pregnant or lactating women
- Known alcohol or drug addiction or abuse within the last 2 years
- Subject institutionalized under judicial decision
- Problems of venous accessibility
- Subject taking part in another clinical / pharmacological study in the month preceding enrollment (Visit 1)
- Investigators, coinvestigators, their spouses or children, or any study collaborators
- Subjects previously treated with Brivaracetam (BRV)
- Subject previously screened within this study
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01405508
Start Date
August 1 2011
End Date
July 1 2012
Last Update
July 11 2018
Active Locations (17)
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1
001
Phoenix, Arizona, United States
2
775
Little Rock, Arkansas, United States
3
780
Lexington, Kentucky, United States
4
008
Bethesda, Maryland, United States