Trial record 1 of 2 for: NCT01405508

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Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy

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ClinicalTrials.gov Identifier: NCT01405508

Recruitment Status : Completed

First Posted : July 29, 2011

Results First Posted : April 13, 2016

Last Update Posted : July 11, 2018

Sponsor:

Information provided by (Responsible Party):

UCB Pharma

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Epilepsy
Interventions:	Drug: Brivaracetam tablets Drug: Brivaracetam bolus Drug: Brivaracetam infusion Other: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study started to recruit patients in August 2011 and concluded in July 2012. 105 subjects were randomized to 4 different treatment groups.

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This study started to recruit patients in August 2011 and concluded in July 2012.

105 subjects were randomized to 4 different treatment groups.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant Flow refers to the Randomized Set (RS).

Reporting Groups

	Description
Placebo Tablets / Brivaracetam Bolus	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
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: 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
Brivaracetam (BRV) Tablets / BRV Bolus	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
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: 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

Participant Flow: Overall Study

	Placebo Tablets / Brivaracetam Bolus	Placebo Tablets / Brivaracetam Infusion	Brivaracetam (BRV) Tablets / BRV Bolus	Brivaracetam (BRV) Tablets / BRV Infusion
STARTED	26	26	27	26
COMPLETED	25	25	27	26
NOT COMPLETED	1	1	0	0
AE, non-serious non-fatal	1	1	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline Characetristics refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.

Reporting Groups

	Description
Placebo Tablets / Brivaracetam Bolus	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
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: 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
Brivaracetam (BRV) Tablets / BRV Bolus	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
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: 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
Total Title	No text entered.

Baseline Measures

	Placebo Tablets / Brivaracetam Bolus	Placebo Tablets / Brivaracetam Infusion	Brivaracetam (BRV) Tablets / BRV Bolus	Brivaracetam (BRV) Tablets / BRV Infusion	Total Title
Overall Participants Analyzed [Units: Participants]	26	26	27	26	105

Age [Units: Participants] Count of Participants
<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Between 18 and 65 years	26 100.0%	25 96.2%	27 100.0%	25 96.2%	103 98.1%
>=65 years	0 0.0%	1 3.8%	0 0.0%	1 3.8%	2 1.9%

Age [Units: Years] Mean (Standard Deviation)	40.6 (12.2)	39.5 (14.4)	42.0 (9.2)	44.4 (12.6)	41.6 (12.2)

Sex: Female, Male [Units: Participants] Count of Participants
Female	12 46.2%	10 38.5%	17 63.0%	17 65.4%	56 53.3%
Male	14 53.8%	16 61.5%	10 37.0%	9 34.6%	49 46.7%

Outcome Measures

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1. Primary:

Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days) [ Time Frame: 40 days ]

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2. Secondary:

Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days) [ Time Frame: 40 days ]

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3. Secondary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: UCB (Study Director)
Organization: UCB Cares
phone: +1 887 822 9493

Responsible Party:	UCB Pharma
ClinicalTrials.gov Identifier:	NCT01405508 History of Changes
Other Study ID Numbers:	N01258 2008-004714-27 ( EudraCT Number )
First Submitted:	July 27, 2011
First Posted:	July 29, 2011
Results First Submitted:	March 14, 2016
Results First Posted:	April 13, 2016
Last Update Posted:	July 11, 2018

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