A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00175825
• Collaborator: (none)
• Enrollment: 210
• Locations: 42
• Arms: 4
• Actual Duration (Months): 7.7
• Patients Per Site: 5
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Other: Placebo; Drug: Brivaracetam	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
• Actual Study Start Date: Nov 7, 2005
• Actual Primary Completion Date: Jun 29, 2006
• Actual Study Completion Date: Jun 29, 2006

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Matching Placebo tablets administered twice a day	Other: Placebo; Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period
Experimental: Brivaracetam 5 mg/day Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Drug: Brivaracetam; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period; Other Names: Briviact
Experimental: Brivaracetam 20 mg/day Brivaracetam 20 mg/day, 10 mg administered twice a day	Drug: Brivaracetam; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period; Other Names: Briviact
Experimental: Brivaracetam 50 mg/day Brivaracetam 50 mg/day, 25 mg administered twice a day	Drug: Brivaracetam; Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period; Other Names: Briviact

Outcome Measures

Primary Outcome Measures

1. Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period [During the 7-week Treatment Period]

   Calculated as 7-day partial onset seizure frequency.

Secondary Outcome Measures

1. Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period [Baseline, during the 7-week Treatment Period]

   Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.

2. Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period [During the 7-week Treatment Period]

   Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.

3. Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period [During the 7-week Treatment Period]

   Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

4. Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period [During the 7-week Treatment Period]

   Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.

5. Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period [During the 7-week Treatment Period]

   Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.

6. Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period [During the 7-week Treatment Period]

   A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.

7. Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period [During the 7-week Treatment Period]

   Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.

8. Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period [During the 7-week Treatment Period]

   A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.

9. Number of Seizure-free Days Per 4 Weeks [Baseline, during the 7-week Treatment Period]

   A day was considered seizure-free, if no seizure was reported during 24 hours.

10. Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period [During the 7-week Treatment Period]

    Number of days to first, fifth, and tenth seizure after baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male/female from 16 to 65 years

• Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification

• History of partial onset seizures

• Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1

• Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria:

• Seizure type IA non-motor as only seizure type

• Seizures occurring only in clusters

• Status epilepticus during the last 2 years before Visit 1

• History of cerebrovascular accident (CVA)

• Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Little Rock	Arkansas	United States
3		Fresno	California	United States
4		Bradenton	Florida	United States
5		Jacksonville	Florida	United States
6		Chicago	Illinois	United States
7		Paducah	Kentucky	United States
8		Ruston	Louisiana	United States
9		Bethesda	Maryland	United States
10		Burlington	Massachusetts	United States
11		Grand Rapids	Michigan	United States
12		Rochester	Minnesota	United States
13		Tupelo	Mississippi	United States
14		Chesterfield	Missouri	United States
15		Great Falls	Montana	United States
16		Englewood Cliffs	New Jersey	United States
17		Toms River	New Jersey	United States
18		New York	New York	United States
19		Wilmington	North Carolina	United States
20		Columbus	Ohio	United States
21		Philadelphia	Pennsylvania	United States
22		Woonsocket	Rhode Island	United States
23		Greenville	South Carolina	United States
24		Dallas	Texas	United States
25		Houston	Texas	United States
26		Salt Lake City	Utah	United States
27		Florianopolis		Brazil
28		Salvador		Brazil
29		Sao Paulo		Brazil
30		Bangalore		India
31		Hyderabad		India
32		Lucknow		India
33		Parel Mumbai		India
34		Trivandrum		India
35		Aguascalientes		Mexico
36		Chichuahua		Mexico
37		Chihuahua		Mexico
38		Guadalajara		Mexico
39		Monterrey		Mexico
40		San Luis Potosi		Mexico
41		Valle Oriente Garza Garcia		Mexico
42		Zapopan		Mexico

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Cares, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Product Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00175825
• Other Study ID Numbers: N01193
• First Posted: Sep 15, 2005
• Last Update Posted: Oct 2, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by UCB Pharma: Epilepsy: partial onset seizures; brivaracetam
• Additional relevant MeSH terms: Epilepsy; Seizures; Brivaracetam

Study Results

Participant Flow

Recruitment Details	The study started to enroll patients in November 2005 and concluded in June 2006.
Pre-assignment Detail	Participant Flow refers to the Intention-to-treat (ITT) Set. 210 subjects were initially randomized, 2 subjects discontinued due to Lost to Follow-Up before first study drug intake.

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Period Title: Overall Study
STARTED	54	50	52	52
COMPLETED	49	46	51	51
NOT COMPLETED	5	4	1	1

Baseline Characteristics

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day	Total Title
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Overall Participants	54	50	52	52	208
Age (Count of Participants)
<=18 years	3 5.6%	4 8%	1 1.9%	5 9.6%	13 6.3%
Between 18 and 65 years	51 94.4%	46 92%	50 96.2%	47 90.4%	194 93.3%
>=65 years	0 0%	0 0%	1 1.9%	0 0%	1 0.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.59 (11.26)	32.72 (12.16)	35.31 (13.66)	30.92 (11.57)	33.15 (12.20)
Sex: Female, Male (Count of Participants)
Female	30 55.6%	20 40%	24 46.2%	24 46.2%	98 47.1%
Male	24 44.4%	30 60%	28 53.8%	28 53.8%	110 52.9%

Outcome Measures

1. Secondary Outcome

Title	Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period
Description	Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame	Baseline, during the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Median (Inter-Quartile Range) [percentage of change]	-21.7	-29.91	-42.56	-53.04

2. Secondary Outcome

Title	Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period
Description	Types I+II+III seizure frequency (Type I: Partial (focal, local), Type II: Generalized (convulsive or nonconvulsive), Type III: Unclassified) per week will be derived from the seizure count information recorded on the daily record card (e.g. date, number, type of epileptic seizures) and is defined as the number of seizures standardized to a 7-day period.
Time Frame	During the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Baseline	2.23	2.21	2.50	1.99
Treatment	1.81	1.61	1.70	0.92

3. Secondary Outcome

Title	Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period
Description	Calculated as 7-day Partial Onset Seizures (Type I) frequency during the 7-week Treatment Period 7-day seizure frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame	During the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Median (Inter-Quartile Range) [seizures per week]	-0.37	-0.66	-0.84	-0.92

4. Secondary Outcome

Title	Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Description	Calculated as 7-day seizure frequency during the 7-week Treatment Period 7-day seizure (Types I + II + III) frequency during the Baseline Period. A negative value from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame	During the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Median (Inter-Quartile Range) [seizures per week]	-0.40	-0.66	-0.80	-0.92

5. Secondary Outcome

Title	Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
Description	Calculated as 7-day seizure frequency during the 7-week Treatment Period - 7-day seizure frequency during the Baseline Period, divided by the 7-day seizure frequency during the Baseline Period with this quantity multiplied by 100. A negative value in percent change from Baseline indicates a decrease in partial seizure frequency from Baseline.
Time Frame	During the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Median (Inter-Quartile Range) [percentage of change]	-24.35	-29.91	-41.57	-53.05

6. Secondary Outcome

Title	Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period
Description	A responder was defined as a subject with a >= 50 % reduction in seizure frequency per week from the Baseline Period to the end of the Treatment Period.
Time Frame	During the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Number [percentage of participants]	16.7 30.9%	32.0 64%	44.2 85%	55.8 107.3%

7. Secondary Outcome

Title	Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period
Description	Categories of percentage reductions in seizures from baseline were as following: < -25 %; -25 % to <25 %; 25 % to <75 %; 75 % to <100 %; 100 %.
Time Frame	During the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
< -25%	18.5 34.3%	8.0 16%	9.6 18.5%	13.5 26%
-25% to <25%	35.2 65.2%	38.0 76%	30.8 59.2%	13.5 26%
25% to <75%	40.7 75.4%	42.0 84%	40.4 77.7%	55.8 107.3%
75% to <100%	1.9 3.5%	4.0 8%	11.5 22.1%	9.6 18.5%
100%	3.7 6.9%	8.0 16%	7.7 14.8%	7.7 14.8%

8. Secondary Outcome

Title	Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period
Description	A subject was considered seizure free, if no seizure was reported during the 7-week Treatment Period.
Time Frame	During the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Completed the Period	1.9 3.5%	8.0 16%	7.7 14.8%	5.8 11.2%
Discontinued from the Period	1.9 3.5%	0 0%	0 0%	0 0%

9. Secondary Outcome

Title	Number of Seizure-free Days Per 4 Weeks
Description	A day was considered seizure-free, if no seizure was reported during 24 hours.
Time Frame	Baseline, during the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Median (Inter-Quartile Range) [Days/4 Weeks]	22.66	22.86	22.84	24.65

10. Secondary Outcome

Title	Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period
Description	Number of days to first, fifth, and tenth seizure after baseline.
Time Frame	During the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Number of days to first seizure after baseline	4.0	4.0	4.5	7.0
Number of days to fifth seizure after baseline	17.0	20.0	18.5	32.5
Number of days to tenth seizure after baseline	32.0	38.0	39.0	57.0

11. Primary Outcome

Title	Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
Description	Calculated as 7-day partial onset seizure frequency.
Time Frame	During the 7-week Treatment Period

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	Brivaracetam 5 mg/Day	Brivaracetam 20 mg/Day	Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day	Brivaracetam 5 mg/day, 2.5 mg administered twice a day	Brivaracetam 20 mg/day, 10 mg administered twice a day	Brivaracetam 50 mg/day, 25 mg administered twice a day
Measure Participants	54	50	52	52
Median (Inter-Quartile Range) [Seizures per week]	1.81	1.61	1.55	0.92

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Brivaracetam 5 mg/Day
	Comments	ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.240
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Percent reduction over Placebo
	Estimated Value	9.8
	Confidence Interval	(2-Sided) 95%; -7.2 to 24.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Brivaracetam 20 mg/Day
	Comments	ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.062
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Percent reduction over Placebo
	Estimated Value	14.9
	Confidence Interval	(2-Sided) 95%; -0.8 to 28.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Brivaracetam 50 mg/Day
	Comments	ANCOVA with baseline seizure frequency per week and each of the stratification factors as independent variables.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=0.004
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Percent reduction over Placebo
	Estimated Value	22.1
	Confidence Interval	(2-Sided) 95%; 7.6 to 34.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse events were collected from Baseline until Safety Visit (up to 3 months).
Adverse Event Reporting Description	Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
Arm/Group Title	Placebo		Brivaracetam 5 mg/Day		Brivaracetam 20 mg/Day		Brivaracetam 50 mg/Day
Arm/Group Description	Matching Placebo tablets administered twice a day		Brivaracetam 5 mg/day, 2.5 mg administered twice a day		Brivaracetam 20 mg/day, 10 mg administered twice a day		Brivaracetam 50 mg/day, 25 mg administered twice a day
All Cause Mortality
	Placebo		Brivaracetam 5 mg/Day		Brivaracetam 20 mg/Day		Brivaracetam 50 mg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/50 (0%)		0/52 (0%)		0/52 (0%)
Serious Adverse Events
	Placebo		Brivaracetam 5 mg/Day		Brivaracetam 20 mg/Day		Brivaracetam 50 mg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/50 (0%)		1/52 (1.9%)		0/52 (0%)
Nervous system disorders
Neurotoxicity	0/54 (0%)		0/50 (0%)		1/52 (1.9%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Brivaracetam 5 mg/Day		Brivaracetam 20 mg/Day		Brivaracetam 50 mg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/54 (27.8%)		13/50 (26%)		8/52 (15.4%)		10/52 (19.2%)
Blood and lymphatic system disorders
Neutropenia	1/54 (1.9%)		4/50 (8%)		2/52 (3.8%)		1/52 (1.9%)
General disorders
Fatigue	2/54 (3.7%)		0/50 (0%)		2/52 (3.8%)		3/52 (5.8%)
Infections and infestations
Influenza	4/54 (7.4%)		4/50 (8%)		0/52 (0%)		1/52 (1.9%)
Nervous system disorders
Dizziness	3/54 (5.6%)		1/50 (2%)		0/52 (0%)		4/52 (7.7%)
Headache	4/54 (7.4%)		4/50 (8%)		2/52 (3.8%)		1/52 (1.9%)
Somnolence	4/54 (7.4%)		1/50 (2%)		3/52 (5.8%)		3/52 (5.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.