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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00368251
First received: August 23, 2006
Last updated: March 14, 2016
Last verified: March 2016
Results First Received: March 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Unverricht-Lundborg Disease
Interventions: Other: Placebo
Drug: BRV 2.5 mg
Drug: BRV 25 mg
Drug: BRV 50 mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
72 subjects were screened, 56 subjects were randomized. Participant Flow refers to all subjects randomized who are identical with the Intent-To-Treat (ITT) Population, which consists of all randomized subjects who took at least one dose of study medication.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
Brivaracetam 5 mg/Day Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
Brivaracetam 150 mg/Day Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)

Participant Flow:   Overall Study
    Placebo     Brivaracetam 5 mg/Day     Brivaracetam 150 mg/Day  
STARTED     18     20     18  
COMPLETED     17     20     17  
NOT COMPLETED     1     0     1  
SAE, non-fatal                 1                 0                 0  
AE, non-serious non-fatal                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The Baseline Analysis Population contains all randomized subjects who are identical with the Intent-To-Treat (ITT) population.

Reporting Groups
  Description
Placebo Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
Brivaracetam 5 mg/Day Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
Brivaracetam 150 mg/Day Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
Total Title No text entered.

Baseline Measures
    Placebo     Brivaracetam 5 mg/Day     Brivaracetam 150 mg/Day     Total Title  
Number of Participants  
[units: participants]
  18     20     18     56  
Age  
[units: participants]
       
<=18 years     0     1     1     2  
Between 18 and 65 years     18     19     17     54  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
       
mean (standard deviation)     34.3  (9.2)     35.8  (10.9)     33.7  (11.4)     34.65  (10.38)  
Gender  
[units: participants]
       
Female     12     11     9     32  
Male     6     9     9     24  
Region of Enrollment  
[units: participants]
       
Serbia     2     2     2     6  
France     3     2     3     8  
United States     2     3     4     9  
Canada     4     3     2     9  
Finland     3     4     2     9  
Russian Federation     2     3     3     8  
Israel     0     0     2     2  
Tunisia     2     3     0     5  



  Outcome Measures
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1.  Primary:   Percent Change From Baseline to the End of Treatment Period on the Action Myoclonus Score (Unified Myoclonus Rating Scale (UMRS) Section 4)   [ Time Frame: From Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) ]

2.  Secondary:   Percent Change From Baseline to the End of Treatment Period on the Functional Disability Score (Unified Myoclonus Rating Scale (UMRS) Section 5)   [ Time Frame: Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) ]

3.  Secondary:   Percent Change From Baseline to the End of Treatment Period on the Stimulus Sensitivity Score (Unified Myoclonus Rating Scale (UMRS) Section 3)   [ Time Frame: Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) ]

4.  Secondary:   Percent Change From Baseline to the End of Treatment Period on the Myoclonus Patient Questionnaire (Unified Myoclonus Rating Scale (UMRS) Section 1)   [ Time Frame: Baseline to End of Treatment Period (Week 14 or Early Discontinuation Visit) ]

5.  Secondary:   Global Evaluation Score (Investigator) at the End of Treatment Period   [ Time Frame: End of Treatment Period (Week 14 or Early Discontinuation Visit) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
phone: +1877 822 ext 9493


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00368251     History of Changes
Other Study ID Numbers: N01236
2006-001536-46 ( EudraCT Number )
Study First Received: August 23, 2006
Results First Received: March 14, 2016
Last Updated: March 14, 2016
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
European Union: European Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish National Agency for Medicines
Israel: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Serbia: Medicines and Medical Devices Agency