Brivaracetam as add-on Treatment of Unverricht-Lundborg D... | NCT00368251

ID	Type	Description	Link
2006-001536-46	EudraCT Number

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)	Other: Placebo
Brivaracetam 5 mg/day	Experimental	Brivaracetam (BRV) 5 mg/day 5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)	Drug: BRV 2.5 mg
Brivaracetam 150 mg/day	Experimental	Brivaracetam (BRV) 150 mg/day 150 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)	Drug: BRV 25 mg Drug: BRV 50 mg

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Pharmaceutical Form: Tablet Concentration: 2.5 mg, 25 mg and 50 mg Route of Administration: Oral use	Placebo

Measure	Description	Time Frame
Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)	The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.	From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)

Measure	Description	Time Frame
Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)	The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit.	Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Subjects with diagnosed Unverricht-Lundborg disease (ULD) ascertained by appropriate genetic testing for a homozygous or compound heterozygous mutation in the CSTB gene- Subjects with moderate to severe myoclonus documented by an Action Myoclonussum score of ≥ 30 (evaluation by investigator)-Subjects currently being or having been treated with clonazepam up to the maximum recommended daily dose of 20 mg or up to their individual optimal dose as assessed by the investigator- Subjects currently being or having been treated with valproate up to the maximum recommended daily dose 60 mg/kg or serum levels of 100 mcg/ml or up to their individual optimal dose as specified by the investigator- Male/female subjects from 16 years onwards. Subjects under 18 years may only be included where legally permitted and ethically accepted

Exclusion Criteria:

- Subjects currently on felbamate or having been on felbamate within less than 18 months prior to Visit 1- Subjects currently treated with phenytoin or having been on phenytoin in the last month prior to Visit 1- Subjects currently on vigabatrine. Subjects having been on vigabatrine if no visual fields examination report available including standard static (Humphrey or Octopus) or cinetic perimetry (Goldman)- Subject taking any drug with possible central nervous system (CNS) effects- Subjects taking any drug that may significantly influence the metabolism of BRV (CYP2C or CYP3A potent inducers/inhibitors)- Known clinically significant acute or chronic illness or illness which may impair reliable participation in the trial, necessitate the use of medication not allowed by protocol or represent a safety risk in the Investigator's opinion- Subjects with history of severe adverse hematological reaction to any drug- Impaired hepatic function: ALAT/SGPT, ASAT/SGOT, alkaline phosphatase, GGT value of more than three times the upper limit of the reference range- History of suicide attempt during the last 5 years- Subject with suicidal ideations within the last year or at risk of suicide attempt unless cleared by written confirmation from a psychiatrist and approved by the UCB physician- Ongoing psychiatric disorder other than mild controlled disorder

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
135		San Francisco	California		United States
133

PubMed Identifier	Type	Citation	Retractions
33461041	Derived	Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.
26666500

Label	URL
Product Information	View source

ID	Title	Description
FG000	Placebo	Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
FG001	Brivaracetam 5 mg/Day	Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)

ID	Title	Description
BG000	Placebo	Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
BG001	Brivaracetam 5 mg/Day	Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
BG002	Brivaracetam 150 mg/Day	Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
BG003	Total Title

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)

The range for Action Myoclonus Score (centrally read) is 0 (best) - 160 (worst). Percent change from Baseline = 100 X ((Baseline UMRS4 - Treatment UMRS4) / Baseline UMRS4). Baseline is defined as the last non-missing value prior to or on Randomization Visit.

The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the functional disability score (UMRS section 5). In case a subject drops out, the result at Early Discontinuation Visit is used.

Posted

Median

Full Range

Percent change

From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)

ID	Title	Description
OG000	Placebo	Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
OG001	Brivaracetam 5 mg/Day	Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
OG002	Brivaracetam 150 mg/Day	Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)

Units	Counts
Participants	OG00018 OG00120 OG00218

Title

Denominators

Categories

Title	Measurements
	OG00017.45(-170.0 to 61.5) OG001-4.60(-430.0 to 81.8) OG00212.34(-58.3 to 96.9)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	The first hypothesis for the primary efficacy variable compares placebo versus Brivaracetam (BRV) 150 mg/day. The second hypothesis for the primary efficacy variable compares placebo versus BRV 5 mg/day. However, this second hypothesis will only be tested when all the hypotheses for placebo versus BRV 150 mg/day are significant for the primary three UMRS related secondary endpoints. The hypotheses will be tested using nonparametric analysis. The study was designed to have 80 % power.	stratified Wilcoxon Test	Estimates and confidence intervals from Hodges-Lehmann (unstratified).	=0.942	All hypotheses are tested at the 5 % level. The multiplicity scheme (hierarchical testing procedure) assures strong control of the type I error at the 5 % level.	Hodges-Lehmann-estimator of difference	0.15			2-Sided	95	-26.12	24.96

Secondary

Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)

The range for Functional Disability Score is 0 (best) to 28 (worst). Percent change from Baseline = 100 X ((Baseline UMRS5 - Treatment UMRS5) / Baseline UMRS5). Baseline is defined as the last non-missing value prior to or on Randomization Visit.

Posted

Median

Full Range

Percent change

Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)

ID	Title	Description
OG000	Placebo	Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
OG001	Brivaracetam 5 mg/Day	Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
OG002	Brivaracetam 150 mg/Day	Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)

Secondary

Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3)

The range for Stimulus Sensitivity Score is 0 (best) to 17 (worst). Percent change from Baseline = 100 X ((Baseline UMRS3 - Treatment UMRS3) / Baseline UMRS3). Baseline is defined as the last non-missing value prior to or on Randomization Visit.

The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the stimulus sensitivity score (UMRS section 3). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.

Posted

Median

Full Range

Percent change

Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)

ID	Title	Description
OG000	Placebo	Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
OG001	Brivaracetam 5 mg/Day	Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
OG002	Brivaracetam 150 mg/Day	Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)

Secondary

Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1)

The range for Myoclonus Patient Questionnaire is 0 (best) to 44 (worst). Percent change from Baseline = 100 X ((Baseline UMRS1 - Treatment UMRS1) / Baseline UMRS1). Baseline is defined as the last non-missing value prior to or on Randomization Visit.

The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the percent change from baseline on the Myoclonus Patient Questionnaire (UMRS section 1). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.

Posted

Median

Full Range

Percent change

Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit)

ID	Title	Description
OG000	Placebo	Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
OG001	Brivaracetam 5 mg/Day	Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
OG002	Brivaracetam 150 mg/Day	Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)

Secondary

Global Evaluation Score (Investigator) at the End of Treatment Period

The Global Evaluation Scale Score (Investigator) ranges from 1 (Marked worsening) to 7 (Marked improvement).

The number of subjects is equal to the number of subjects in the Intent-To-Treat (ITT) population having non-missing post-baseline results for the Global Evaluation Score (I-GES). In case a subject drops out, the result at Early Discontinuation Visit (EDV) is used.

Posted

Number

percentage of participants

End of Treatment Period (Week 14 or Early Discontinuation Visit)

ID	Title	Description
OG000	Placebo	Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
OG001	Brivaracetam 5 mg/Day	Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
OG002	Brivaracetam 150 mg/Day	Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Granulocytopenia	Blood and lymphatic system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0022 events1 affected18 at risk
Angina pectoris	Cardiac disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Electrocardiogram QT corrected interval prolonged	Cardiac disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected20 at risk EG0020 events0 affected18 at risk
Middle ear inflammation	Ear and labyrinth disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Nausea	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected20 at risk EG0021 events1 affected18 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0012 events2 affected20 at risk EG0020 events0 affected18 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0003 events2 affected18 at risk EG0011 events1 affected20 at risk EG0021 events1 affected18 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0003 events1 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Constipation	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Toothache	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Fatigue	General disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0011 events1 affected20 at risk EG0026 events3 affected18 at risk
Oedema peripheral	General disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Pyrexia	General disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Nasopharyngitis	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0004 events3 affected18 at risk EG0011 events1 affected20 at risk EG0021 events1 affected18 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected20 at risk EG0023 events1 affected18 at risk
Gastrointestinal infection	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected20 at risk EG0020 events0 affected18 at risk
Gastroenteritis	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Otitis externa	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0003 events2 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Pharyngitis	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Sinusitis	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Urinary tract infection	Infections and infestations	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Weight decreased	Metabolism and nutrition disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected20 at risk EG0021 events1 affected18 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Increased appetite	Metabolism and nutrition disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Weight increased	Metabolism and nutrition disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected20 at risk EG0021 events1 affected18 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0022 events1 affected18 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected20 at risk EG0020 events0 affected18 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0022 events1 affected18 at risk
Shoulder pain	Musculoskeletal and connective tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Myoclonus	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events1 affected18 at risk EG0014 events4 affected20 at risk EG0024 events3 affected18 at risk
Somnolence	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0013 events3 affected20 at risk EG0027 events4 affected18 at risk
Headache	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0008 events7 affected18 at risk EG0014 events3 affected20 at risk EG0022 events2 affected18 at risk
Balance disorder	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0011 events1 affected20 at risk EG0024 events2 affected18 at risk
Dizziness	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0011 events1 affected20 at risk EG0021 events1 affected18 at risk
Grand mal convulsion	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0012 events2 affected20 at risk EG0020 events0 affected18 at risk
Hyporeflexia	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0022 events2 affected18 at risk
Complex partial seizures	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Coordination abnormal	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Dysarthria	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0022 events1 affected18 at risk
Migraine	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0023 events1 affected18 at risk
Nystagmus	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Tremor	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0004 events3 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Convulsion	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Myoclonic epilepsy	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Sciatica	Nervous system disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Aggression	Psychiatric disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0012 events2 affected20 at risk EG0020 events0 affected18 at risk
Insomnia	Psychiatric disorders	MedDRA9.0	Non-systematic Assessment	EG0002 events2 affected18 at risk EG0012 events2 affected20 at risk EG0020 events0 affected18 at risk
Anxiety	Psychiatric disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Depression	Psychiatric disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0011 events1 affected20 at risk EG0020 events0 affected18 at risk
Bradyphrenia	Psychiatric disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Depressed mood	Psychiatric disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Disorientation	Psychiatric disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Memory impairment	Psychiatric disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Enuresis	Renal and urinary disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Pollakiuria	Renal and urinary disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Genital pruritus female	Reproductive system and breast disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Ingrowing nail	Skin and subcutaneous tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0000 events0 affected18 at risk EG0010 events0 affected20 at risk EG0021 events1 affected18 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk
Haematoma	Vascular disorders	MedDRA9.0	Non-systematic Assessment	EG0001 events1 affected18 at risk EG0010 events0 affected20 at risk EG0020 events0 affected18 at risk

ID	Term
D020194	Unverricht-Lundborg Syndrome
D020191	Myoclonic Epilepsies, Progressive
D009207	Myoclonus

ID	Term
D004831	Epilepsies, Myoclonic
D004829	Epilepsy, Generalized
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D000073376	Epileptic Syndromes
D020271	Heredodegenerative Disorders, Nervous System
D019636	Neurodegenerative Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D020820	Dyskinesias
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)	2	18	13	18
EG001	Brivaracetam 5 mg/Day	Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)	3	20	13	20
EG002	Brivaracetam 150 mg/Day	Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)	2	18	15	18