Brivaracetam as add-on Treatment of Unverricht-Lundborg D... | NCT00357669

ID	Type	Description	Link
2006-000169-12	EudraCT Number

Status Module

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Other: Placebo
Brivaracetam 50 mg/day	Experimental	BRV 50 mg/day	Drug: Brivaracetam 25 mg Drug: Brivaracetam 50 mg
Brivaracetam 150 mg/day	Experimental	BRV 150 mg/day	Drug: Brivaracetam 25 mg Drug: Brivaracetam 50 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brivaracetam 25 mg	Drug	Active Substance: Brivaracetam Pharmaceutical Form: Tablet Concentration: 25 mg Route of Administration: Oral use	Brivaracetam 150 mg/day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent reduction from baseline on the Action Myoclonus score (Unified Myoclonus Rating Scale (UMRS) Section 4) at the end of the Treatment Period		End of treatment period (Week 14 or early discontinuation visit)

Secondary Outcomes

Measure	Description	Time Frame
Percent reduction from baseline on the functional disability score (UMRS Section 5) at the end of the Treatment Period		End of treatment period (week 14 or early discontinuation visit)
Percent reduction from baseline on the stimulus sensitivity score (UMRS Section 3) at the end of the Treatment Period

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 Cystatin B (CSTB) gene
Subjects with moderate to severe myoclonus documented by an Action Myoclonus sum 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

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

References Module

Citations

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

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

Ancestor Terms

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

Facility	Status	City	State	ZIP	Country	Contacts
		Kuopio			Finland