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

This study has been completed.

Sponsored by: UCB
Information provided by: UCB
ClinicalTrials.gov Identifier: NCT00357669
  Purpose

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


Condition Intervention Phase
Unverricht-Lundborg Disease
Drug: Brivaracetam (ucb 34714)
Phase III

Genetics Home Reference related topics:   familial encephalopathy with neuroserpin inclusion bodies    pyridoxal 5'-phosphate-dependent epilepsy    Unverricht-Lundborg disease   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:   A Multicenter, 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 With Genetically Ascertained ULD

Further study details as provided by UCB:

Primary Outcome Measures:
  • Efficacy of BRV on the symptom relief of myoclonus. The change in scores of action myoclonus (Section 4) of the Unified Myoclonus Rating Scale at 4, 8 and 14 weeks.

Secondary Outcome Measures:
  • The scores on sections 1 (Myoclonus Patient Questionnaire), 3 (Stimulus sensitivity) and 5 (Functional disability test) of the Unified Myoclonus Rating Scale at 4, 8 and 14 weeks.

Enrollment:   50
Study Start Date:   November 2006
Study Completion Date:   October 2007
Primary Completion Date:   October 2007 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

  • Subjects with diagnosed ULD ascertained by appropriate genetic testing.

Exclusion Criteria:

  • Patients who never received adequate treatment before, i.e. with VPA or CZP
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357669

Locations
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

Sponsors and Collaborators
UCB

Investigators
Study Director:     Dr. Philipp von Rosenstiel     UCB S.A.    
  More Information


Study ID Numbers:   N01187, RPCE06C2321
First Received:   July 25, 2006
Last Updated:   March 19, 2008
ClinicalTrials.gov Identifier:   NCT00357669
Health Authority:   European Union: European Medicines Agency

Keywords provided by UCB:
Unverricht-Lundborg disease  
Baltic myoclonus  
progressive myoclonic epilepsies  
myoclonus  
brivaracetam  

Study placed in the following topic categories:
Epilepsies, Myoclonic
Myoclonus
Unverricht-Lundborg Syndrome
Heredodegenerative Disorders, Nervous System
Myoclonus epilepsy
Genetic Diseases, Inborn
Epilepsy
Central Nervous System Diseases
Myoclonic Epilepsies, Progressive
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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