Trial record 1 of 1 for:
NCT01405508
Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy
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| ClinicalTrials.gov Identifier: NCT01405508 |
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Recruitment Status :
Completed
First Posted : July 29, 2011
Results First Posted : April 13, 2016
Last Update Posted : July 11, 2018
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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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 according to an initiation or a conversion scheme, during repeated dosing (100 mg/administration twice daily for 4.5 days).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Drug: Brivaracetam tablets Drug: Brivaracetam bolus Drug: Brivaracetam infusion Other: Placebo | Phase 3 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 105 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-center, Open-label, Four-arm, Randomized Trial Evaluating the Safety and Tolerability of Brivaracetam Intravenous Infusion and Bolus, Administered in BID Regimen as an Adjunctive Antiepileptic Treatment in Subjects From 16 to 70 Years Suffering From Epilepsy |
| Study Start Date : | August 2011 |
| Actual Primary Completion Date : | July 2012 |
| Actual Study Completion Date : | July 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
Drug Information available for:
Brivaracetam
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Placebo tablets / Brivaracetam bolus
Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days. Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week |
Drug: Brivaracetam bolus
10 mL (= 100 mg) of Brivaracetam administered intravenously over 2 minutes twice daily (BID) during Evaluation Period Other: Placebo 100 mg twice daily (BID) for 7 days during Run-In Period |
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Experimental: Brivaracetam (BRV) tablets / BRV bolus
Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days. Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week |
Drug: Brivaracetam tablets
100 mg, intake twice daily (BID) for 7 days during Run-In Period Drug: Brivaracetam bolus 10 mL (= 100 mg) of Brivaracetam administered intravenously over 2 minutes twice daily (BID) during Evaluation Period |
|
Experimental: Placebo tablets / Brivaracetam infusion
Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days. Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week |
Drug: Brivaracetam infusion
10 mL (= 100 mg) of Brivaracetam diluted in 90 mL 0.9 % isotonic saline sterile solution for intravenous administration infused over 15 minutes twice daily (BID) during Evaluation Period Other: Placebo 100 mg twice daily (BID) for 7 days during Run-In Period |
|
Experimental: Brivaracetam (BRV) tablets / BRV infusion
Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days. Down-Titration:
Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week |
Drug: Brivaracetam tablets
100 mg, intake twice daily (BID) for 7 days during Run-In Period Drug: Brivaracetam infusion 10 mL (= 100 mg) of Brivaracetam diluted in 90 mL 0.9 % isotonic saline sterile solution for intravenous administration infused over 15 minutes twice daily (BID) during Evaluation Period |
Primary Outcome Measures :
- Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days) [ Time Frame: 40 days ]An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Secondary Outcome Measures :
- Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days) [ Time Frame: 40 days ]An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
- Number of Subjects With at Least One Injection-related Treatment-emergent Adverse Event (TEAE) During the Evaluation Period. [ Time Frame: 4.5-day Evaluation Period ]An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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| Ages Eligible for Study: | 16 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405508
Locations
Show 17 study locations
Sponsors and Collaborators
UCB Pharma
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT01405508 |
| Other Study ID Numbers: |
N01258 2008-004714-27 ( EudraCT Number ) |
| First Posted: | July 29, 2011 Key Record Dates |
| Results First Posted: | April 13, 2016 |
| Last Update Posted: | July 11, 2018 |
| Last Verified: | July 2016 |
Keywords provided by UCB Pharma:
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N01258 Brivaracetam Epilepsy IV intravenous |
Additional relevant MeSH terms:
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Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Brivaracetam Anticonvulsants |