CompletedNCT00357669Updated May 18, 2015

Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults

A Phase 3 interventional study of Brivaracetam 25 mg and Brivaracetam 50 mg in Unverricht-Lundborg Disease, sponsored by UCB Pharma SA. Completed at 13 sites in 7 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-05-18.

Sponsored by UCB Pharma SA · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 50
Allocation: Randomized
Ages: 16 Years and older
Sex: All

Study summary

The study will compare the efficacy and safety of brivaracetam with placebo in patients with Unverricht-Lundborg disease.

Conditions studied

Unverricht-Lundborg Disease

Keywords

Unverricht-Lundborg disease
Baltic myoclonus
progressive myoclonic epilepsies
myoclonus
brivaracetam

In context

Lead sponsor

UCB Pharma SA is the lead sponsor of 28 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 50 participants (actual)

Study arms

Placebo comparator
Placebo
Other: Placebo
Experimental
Brivaracetam 50 mg/day
BRV 50 mg/day
Drug: Brivaracetam 25 mg · Drug: Brivaracetam 50 mg
Experimental
Brivaracetam 150 mg/day
BRV 150 mg/day
Drug: Brivaracetam 25 mg · Drug: Brivaracetam 50 mg

Interventions

DrugBrivaracetam 25 mg
* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 25 mg * Route of Administration: Oral use
Also known as: ucb34714
DrugBrivaracetam 50 mg
* Active Substance: Brivaracetam * Pharmaceutical Form: Tablet * Concentration: 50 mg * Route of Administration: Oral use
Also known as: ucb34714
OtherPlacebo
* Active Substance: Placebo Pharmaceutical Form: Tablet * Concentration: 25 mg and 50 mg * Route of Administration: Oral use

What researchers measure

Primary outcomes

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

Secondary outcomes

Percent reduction from baseline on the functional disability score (UMRS Section 5) at the end of the Treatment Period
Time frame: 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
Time frame: End of treatment period (week 14 or early discontinuation visit)
Percent reduction from baseline on the myoclonus patient questionnaire (UMRS Section 1) at the end of the Treatment Period
Time frame: End of treatment period (week 14 or early discontinuation visit)
Global Evaluation Scale by Investigator (I-GES) at the end of the Treatment Period
Time frame: End of treatment period (week 14 or early discontinuation visit)

Study locations

13 sites

Kuopio, Finland
Tampere, Finland
Marseille, France
Montpellier Cedex 5, France
Bologna, Italy
Messina, Italy
Milano, Italy
Napoli, Italy
Heemstede, Netherlands
Heeze, Netherlands
St Pierre Cedex, Réunion
Goteborg, Sweden
Tunis, Tunisia

References and documents

Publications

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. PubMed 33461041 ↗
Kalviainen R, Genton P, Andermann E, Andermann F, Magaudda A, Frucht SJ, Schlit AF, Gerard D, de la Loge C, von Rosenstiel P. Brivaracetam in Unverricht-Lundborg disease (EPM1): Results from two randomized, double-blind, placebo-controlled studies. Epilepsia. 2016 Feb;57(2):210-21. doi: 10.1111/epi.13275. Epub 2015 Dec 15. PubMed 26666500 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00357669
Lead sponsor: UCB Pharma SA
Responsible party: Sponsor
First posted: Jul 27, 2006
Start date: Nov 2006
Primary completion: Oct 2007
Completion: Oct 2007
Last update: May 18, 2015

Study contacts

UCB Clinical Trial Call Center

study director · +1 877 822 9493 (UCB)

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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Unverricht-Lundborg Syndrome

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