Clinical trial NCT01405508
Conditions: Epilepsy
Keywords: N01258 Brivaracetam Epilepsy IV intravenous
Sponsor: UCB Pharma
Start date: 2011-08-01; Completion date: 2012-07-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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).

Detailed description:
Eligible subjects will be randomized in a 1:1:1:1 ratio to the 4 treatment arms

Arms: arm 1: Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.

Down-Titration:

* If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
* If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during 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 arm 2: Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.

Down-Titration:

* If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
* If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during 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 arm 3: Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.

Down-Titration:

* If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
* If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during 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 arm 4: Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.

Down-Titration:

* If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In
* If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during 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
Interventions: intervention 1: Brivaracetam tablets intervention 2: Brivaracetam bolus intervention 3: Brivaracetam infusion intervention 4: Placebo
Intervention descriptions: intervention 1: 100 mg, intake twice daily (BID) for 7 days during Run-In Period intervention 2: 10 mL (= 100 mg) of Brivaracetam administered intravenously over 2 minutes twice daily (BID) during Evaluation Period intervention 3: 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 intervention 4: 100 mg twice daily (BID) for 7 days during Run-In Period

Protocol documents: