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A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

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ClinicalTrials.gov Identifier: NCT00699283
Recruitment Status : Terminated (An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected)
First Posted : June 17, 2008
Results First Posted : January 18, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Brivaracetam
Enrollment 62
Recruitment Details This multi-Center study started to enroll subjects in August 2008 and concluded in March 2010.
Pre-assignment Details The Participant Flow refers to the Randomized Set (RS). Subjects withdrawn due to meeting an exit criterion are included in the count of early discontinuations with a reason of "Adverse Event" or "Lack of efficacy" as reported by the Investigator.
Arm/Group Title Brivaracetam (BRV) 50 mg Brivaracetam (BRV) 100 mg
Hide Arm/Group Description 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study). 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
Period Title: Overall Study
Started 47 15
Completed 14 7
Not Completed 33 8
Reason Not Completed
Lack of Efficacy             15             5
Lost to Follow-up             2             0
Withdrawal by Subject             1             0
Other Reason             5             1
SAE, non-fatal             1             1
AE, non-serious non-fatal             8             1
AE of unknown type             1             0
Arm/Group Title Brivaracetam (BRV) 50 mg Brivaracetam (BRV) 100 mg Total Title
Hide Arm/Group Description 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study). 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study). [Not Specified]
Overall Number of Baseline Participants 47 15 62
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Intent-to-Treat Set (ITT), consisting of all randomized subjects with at least 1 intake of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 15 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 Years
45
  95.7%
14
  93.3%
59
  95.2%
>=65 years
2
   4.3%
1
   6.7%
3
   4.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 15 participants 62 participants
39.0  (13.8) 44.3  (15.9) 40.3  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 15 participants 62 participants
Female
27
  57.4%
11
  73.3%
38
  61.3%
Male
20
  42.6%
4
  26.7%
24
  38.7%
1.Primary Outcome
Title The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
Hide Description The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.
Time Frame From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs.

The Outcome Measure was only pre-specified for the "Brivaracetam (BRV) 50 mg" Arm

Arm/Group Title Efficacy Set (Brivaracetam 50 mg Treated Subjects)
Hide Arm/Group Description:

50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study).

The Efficacy Analysis Set (EFF) consisted of all randomized subjects with at least 1 intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Phase (during the Evaluation Period) and started with the withdrawal of Baseline AEDs.

Overall Number of Participants Analyzed 45
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
0.474
(0.310 to 0.638)
Time Frame Adverse Events were collected from Week 0 over the 1-week BRV Add-On Period and the 15-week Evaluation Period until the end fo Follow-Up Period (Week 23) or Early Discontinuation Visit.
Adverse Event Reporting Description Adverse Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
 
Arm/Group Title Brivaracetam (BRV) 50 mg Brivaracetam (BRV) 100 mg
Hide Arm/Group Description 50 mg daily for 17 weeks (or 21 weeks if down-titrated (50 mg > 20 mg) for subjects not participating in the follow-up study). 100 mg daily for 17 weeks (or 21 weeks if down-titrated (100 mg > 50 mg > 20 mg) for subjects not participating in the follow-up study).
All-Cause Mortality
Brivaracetam (BRV) 50 mg Brivaracetam (BRV) 100 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Brivaracetam (BRV) 50 mg Brivaracetam (BRV) 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/47 (6.38%)      1/15 (6.67%)    
Injury, poisoning and procedural complications     
Intentional overdose * 1  1/47 (2.13%)  1 0/15 (0.00%)  0
Nervous system disorders     
Convulsion * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Epilepsy * 1  1/47 (2.13%)  4 0/15 (0.00%)  0
Status epilepticus * 1  1/47 (2.13%)  1 0/15 (0.00%)  0
Psychiatric disorders     
Suicide attempt * 1  1/47 (2.13%)  1 0/15 (0.00%)  0
Renal and urinary disorders     
Renal failure acute * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brivaracetam (BRV) 50 mg Brivaracetam (BRV) 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/47 (65.96%)      10/15 (66.67%)    
Ear and labyrinth disorders     
Vertigo * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Gastrointestinal disorders     
Nausea * 1  2/47 (4.26%)  2 1/15 (6.67%)  1
Vomiting * 1  3/47 (6.38%)  3 0/15 (0.00%)  0
General disorders     
Fatigue * 1  4/47 (8.51%)  4 2/15 (13.33%)  2
Irritability * 1  5/47 (10.64%)  6 0/15 (0.00%)  0
Asthenia * 1  4/47 (8.51%)  4 0/15 (0.00%)  0
Chest pain * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Infections and infestations     
Asymptomatic bacteriuria * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Bronchitis * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Gastroenteritis * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Nasopharyngitis * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Rhinitis * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Urinary tract infection * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Injury, poisoning and procedural complications     
Skin laceration * 1  1/47 (2.13%)  1 1/15 (6.67%)  1
Muscle strain * 1  0/47 (0.00%)  0 1/15 (6.67%)  2
Investigations     
White blood cells urine positive * 1  1/47 (2.13%)  1 1/15 (6.67%)  1
Electrocardiogram ST segment depression * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Metabolism and nutrition disorders     
Decreased appetite * 1  1/47 (2.13%)  1 2/15 (13.33%)  2
Hypophosphataemia * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Nervous system disorders     
Dizziness * 1  7/47 (14.89%)  8 2/15 (13.33%)  2
Convulsion * 1  5/47 (10.64%)  11 2/15 (13.33%)  2
Headache * 1  4/47 (8.51%)  5 1/15 (6.67%)  1
Grand mal convulsion * 1  3/47 (6.38%)  4 0/15 (0.00%)  0
Lethargy * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Memory impairment * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Psychiatric disorders     
Depression * 1  3/47 (6.38%)  3 2/15 (13.33%)  2
Anxiety * 1  4/47 (8.51%)  5 0/15 (0.00%)  0
Insomnia * 1  4/47 (8.51%)  4 0/15 (0.00%)  0
Suicidal ideation * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Renal and urinary disorders     
Renal failure acute * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
Pruritus * 1  3/47 (6.38%)  3 0/15 (0.00%)  0
Vascular disorders     
Orthostatic hypotension * 1  0/47 (0.00%)  0 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA13.0
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.
Results Point of Contact
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00699283     History of Changes
Other Study ID Numbers: N01306
RPCE07F1216
2008-000145-58 ( EudraCT Number )
First Submitted: June 12, 2008
First Posted: June 17, 2008
Results First Submitted: March 14, 2016
Results First Posted: January 18, 2017
Last Update Posted: July 11, 2018