Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00357669 |
Recruitment Status :
Completed
First Posted : July 27, 2006
Last Update Posted : May 18, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unverricht-Lundborg Disease | Drug: Brivaracetam 25 mg Drug: Brivaracetam 50 mg Other: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment for 12 Weeks in Adolescent and Adult Patients (≥16 Years) With Genetically Ascertained Unverricht-Lundborg Disease |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | October 2007 |
Actual Study Completion Date : | October 2007 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Other: Placebo
|
Experimental: Brivaracetam 50 mg/day
BRV 50 mg/day
|
Drug: Brivaracetam 25 mg
Other Name: ucb34714 Drug: Brivaracetam 50 mg
Other Name: ucb34714 |
Experimental: Brivaracetam 150 mg/day
BRV 150 mg/day
|
Drug: Brivaracetam 25 mg
Other Name: ucb34714 Drug: Brivaracetam 50 mg
Other Name: ucb34714 |
- 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) ]
- 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) ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357669
Finland | |
Kuopio, Finland | |
Tampere, Finland | |
France | |
Marseille, France | |
Montpellier Cedex 5, France | |
Italy | |
Bologna, Italy | |
Messina, Italy | |
Milano, Italy | |
Napoli, Italy | |
Netherlands | |
Heemstede, Netherlands | |
Heeze, Netherlands | |
Réunion | |
St Pierre Cedex, Réunion | |
Sweden | |
Goteborg, Sweden | |
Tunisia | |
Tunis, Tunisia |
Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
Responsible Party: | UCB Pharma SA |
ClinicalTrials.gov Identifier: | NCT00357669 |
Other Study ID Numbers: |
N01187 2006-000169-12 ( EudraCT Number ) |
First Posted: | July 27, 2006 Key Record Dates |
Last Update Posted: | May 18, 2015 |
Last Verified: | May 2015 |
Unverricht-Lundborg disease Baltic myoclonus progressive myoclonic epilepsies myoclonus brivaracetam |
Unverricht-Lundborg Syndrome Myoclonic Epilepsies, Progressive Epilepsies, Myoclonic Epilepsy, Generalized Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Epileptic Syndromes Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Brivaracetam Anticonvulsants |