Trial Outcomes & Findings for Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy (NCT NCT01405508)

Last Updated: 2018-07-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

105 participants

Primary outcome timeframe

40 days

Results posted on

2018-07-11

Participant Flow

This study started to recruit patients in August 2011 and concluded in July 2012. 105 subjects were randomized to 4 different treatment groups.

Participant Flow refers to the Randomized Set (RS).

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	26	26	27	26
Overall Study COMPLETED	25	25	27	26
Overall Study NOT COMPLETED	1	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study AE, non-serious non-fatal	1	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Tablets / Brivaracetam Bolus n=26 Participants 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 n=26 Participants 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 n=27 Participants 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 n=26 Participants 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 n=105 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants	25 Participants n=7 Participants	27 Participants n=5 Participants	25 Participants n=4 Participants	103 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Age, Continuous	40.6 years STANDARD_DEVIATION 12.2 • n=5 Participants	39.5 years STANDARD_DEVIATION 14.4 • n=7 Participants	42.0 years STANDARD_DEVIATION 9.2 • n=5 Participants	44.4 years STANDARD_DEVIATION 12.6 • n=4 Participants	41.6 years STANDARD_DEVIATION 12.2 • n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	56 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	49 Participants n=21 Participants

PRIMARY outcome

Timeframe: 40 days

Population: Safety Population consisting of all subjects who took at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo Tablets / Brivaracetam Infusion n=26 Participants 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 n=27 Participants 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 n=26 Participants 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	Placebo Tablets / Brivaracetam Bolus n=26 Participants 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
Number of Subjects With at Least One Treatment-emergent Adverse Event During the Study (Maximum 40 Days)	19 Participants	21 Participants	20 Participants	20 Participants

SECONDARY outcome

Timeframe: 40 days

Population: Safety Population consisting of all subjects who took at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo Tablets / Brivaracetam Infusion n=26 Participants 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 n=27 Participants 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 n=26 Participants 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	Placebo Tablets / Brivaracetam Bolus n=26 Participants 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
Number of Subjects Who Withdrew Due to a Treatment-emergent Adverse Event During the Study (Maximum 40 Days)	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 4.5-day Evaluation Period

Population: Safety Population consisting of all subjects who took at least 1 dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo Tablets / Brivaracetam Infusion n=26 Participants 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 n=27 Participants 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 n=26 Participants 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	Placebo Tablets / Brivaracetam Bolus n=26 Participants 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
Number of Subjects With at Least One Injection-related Treatment-emergent Adverse Event (TEAE) During the Evaluation Period.	3 Participants	4 Participants	3 Participants	1 Participants

Adverse Events

Placebo Tablets / Brivaracetam Bolus

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo Tablets / Brivaracetam Infusion

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Brivaracetam (BRV) Tablets / BRV Bolus

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Brivaracetam (BRV) Tablets / BRV Infusion

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo Tablets / Brivaracetam Bolus n=26 participants at risk 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 n=26 participants at risk 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 n=27 participants at risk 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 n=26 participants at risk 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
Cardiac disorders Postural orthostatic tachycardia syndrome	7.7% 2/26 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	3.7% 1/27 • Number of events 1 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
Ear and labyrinth disorders Vertigo	3.8% 1/26 • Number of events 1 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.4% 2/27 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
Gastrointestinal disorders Dyspepsia	3.8% 1/26 • Number of events 1 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.4% 2/27 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
General disorders Fatigue	3.8% 1/26 • Number of events 1 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.7% 2/26 • Number of events 4 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	11.1% 3/27 • Number of events 4 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
General disorders Infusion site pain	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	11.5% 3/26 • Number of events 3 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.4% 2/27 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
General disorders Injection site erythema	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.4% 2/27 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
General disorders Injection site pain	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.4% 2/27 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
Nervous system disorders Somnolence	30.8% 8/26 • Number of events 8 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	26.9% 7/26 • Number of events 7 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	25.9% 7/27 • Number of events 9 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	34.6% 9/26 • Number of events 10 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
Nervous system disorders Dizziness	15.4% 4/26 • Number of events 4 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	15.4% 4/26 • Number of events 4 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	11.1% 3/27 • Number of events 3 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	15.4% 4/26 • Number of events 4 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
Nervous system disorders Headache	7.7% 2/26 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.4% 2/27 • Number of events 3 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.7% 2/26 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
Nervous system disorders Dysgeusia	7.7% 2/26 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.4% 2/27 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	7.7% 2/26 • Number of events 2 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/27 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	11.5% 3/26 • Number of events 3 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	3.8% 1/26 • Number of events 1 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/27 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.	0.00% 0/26 • Adverse Events were collected from Baseline over Run-In (Day 1) and Evaluation Period (Day 8 to Day 12) to the Safety Visit or Early Discontinuation Visit (up to 54 days). Adverse Events refer to the Safety Population consisting of all subjects who took at least 1 dose of study drug.

Additional Information

UCB (Study Director)

UCB Cares

Phone: +1 887 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60