Phase 3
N=105
Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01405508 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days) — 20; 19; 21; 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brivaracetam tablets (Drug); Brivaracetam bolus (Drug); Brivaracetam infusion (Drug); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days) |
20; 19; 21; 20 | — |
| SECONDARY Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days) |
1; 1; 0; 0 | — |
| SECONDARY Number of Subjects With at Least One Injection-related Treatment-emergent Adverse Event (TEAE) During the Evaluation Period. |
1; 3; 4; 3 | — |
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 according to an initiation or a conversion scheme, during repeated dosing (100 mg/administration twice daily for 4.5 days).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01405508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.