Trial record 3 of 5 for:    "progressive myoclonus epilepsy with ataxia" OR "Myoclonic Epilepsies, Progressive"

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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00357669
First received: July 25, 2006
Last updated: August 4, 2009
Last verified: August 2009
  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
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Percent reduction from baseline on the Action Myoclonus score (Unified Myoclonus Rating Scale (UMRS) Section 4) [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent reduction from baseline on the functional disability score (UMRS Section 5) [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ] [ Designated as safety issue: No ]
  • Percent reduction from baseline on the stimulus sensitivity score (UMRS Section 3) [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ] [ Designated as safety issue: No ]
  • Percent reduction from baseline on the myoclonus patient questionnaire (UMRS Section 1) [ Time Frame: End of treatment period (week 14 or early discontinuation visit) ] [ Designated as safety issue: No ]

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)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Placebo bid, 14 weeks (2 week up-titration period + 12 week maintenance period)
Experimental: Brivaracetam 50mg/day
BRV 50mg/day
Drug: Brivaracetam
25mg tablet, 50mg bid, 12 weeks (after 2 week up-titration period)
Other Name: ucb34714
Experimental: Brivaracetam 150mg/day
BRV 150mg/day
Drug: Brivaracetam
25 and 50mg tablets, 150 mg bid, 12 weeks (after 2 week up-titration period)
Other Name: ucb34714

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: Study Director, UCB
ClinicalTrials.gov Identifier: NCT00357669     History of Changes
Other Study ID Numbers: N01187, RPCE06C2321
Study First Received: July 25, 2006
Last Updated: August 4, 2009
Health Authority: European Union: European Medicines Agency

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

Additional relevant MeSH terms:
Unverricht-Lundborg Syndrome
Myoclonic Epilepsies, Progressive
Epilepsies, Myoclonic
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 19, 2014