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Trial record 1 of 1 for:    NCT00698581
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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: NCT00698581
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 : April 13, 2016
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 88
Recruitment Details This study started to enroll patients in August 2008 and concluded in February 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 Subjects withdrawn due to meeting an exit criterion are included in the count of early discontinuations with a reason of “Adverse Event” or “Lack of efficacy” as reported by the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 50 mg/Day Brivaracetam 100 mg/Day
Hide Arm/Group Description Brivaracetam: 25 mg tablet - 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) Brivaracetam: 25 mg tablet - 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 68 20
Completed 23 8
Not Completed 45 12
Reason Not Completed
Lack of Efficacy             23             11
Withdrawal by Subject             6             0
Other reason             9             1
SAE, non-fatal             1             0
AE, non-serious non-fatal             4             0
SAE, non-fatal+AE, non-serious non-fatal             1             0
AE of unknown type             1             0
Arm/Group Title Brivaracetam 50 mg/Day Brivaracetam 100 mg/Day Total Title
Hide Arm/Group Description Brivaracetam: 25 mg tablet - 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) Brivaracetam: 25 mg tablet - 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 68 20 88
Hide Baseline Analysis Population Description
Demographics refer to the Randomized Set (RS).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 20 participants 88 participants
37.7  (11.7) 43.6  (13.2) 39.0  (12.2)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 68 participants 20 participants 88 participants
< 65 years 66 19 85
>= 65 years 2 1 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 20 participants 88 participants
Female
33
  48.5%
8
  40.0%
41
  46.6%
Male
35
  51.5%
12
  60.0%
47
  53.4%
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 Week 1 up to Week 17
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
Arm/Group Title Efficacy Analysis Set (BRV 50 mg/Day Treated Subjects)
Hide Arm/Group Description:
The Efficacy Analysis Set (EFF) consists of all randomized subjects with at least one intake of study medication who also entered into the Baseline antiepileptic drug (AED) Tapering Period and started the withdrawal of Baseline AEDs.
Overall Number of Participants Analyzed 67
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of subjects
0.487
(0.347 to 0.626)
2.Secondary Outcome
Title The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
Hide Description [Not Specified]
Time Frame Baseline through Re-conversion (approximately 31 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.
Arm/Group Title Brivaracetam 50 mg/Day Brivaracetam 100 mg/Day
Hide Arm/Group Description:
Brivaracetam: 25 mg tablet - 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)
Brivaracetam: 25 mg tablet - 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)
Overall Number of Participants Analyzed 68 20
Measure Type: Number
Unit of Measure: Participants
53 11
3.Secondary Outcome
Title The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
Hide Description [Not Specified]
Time Frame Baseline through Re-conversion (approximately 31 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.
Arm/Group Title Brivaracetam 50 mg/Day Brivaracetam 100 mg/Day
Hide Arm/Group Description:
Brivaracetam: 25 mg tablet - 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)
Brivaracetam: 25 mg tablet - 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)
Overall Number of Participants Analyzed 68 20
Measure Type: Number
Unit of Measure: Participants
9 2
4.Secondary Outcome
Title The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
Hide Description [Not Specified]
Time Frame Baseline through Re-conversion (approximately 31 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-Treat (ITT) Set consists of all randomized subjects with at least one intake of study medication.
Arm/Group Title Brivaracetam 50 mg/Day Brivaracetam 100 mg/Day
Hide Arm/Group Description:
Brivaracetam: 25 mg tablet - 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)
Brivaracetam: 25 mg tablet - 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)
Overall Number of Participants Analyzed 68 20
Measure Type: Number
Unit of Measure: Participants
5 0
Time Frame Adverse Events (AEs) were collected from Visit 1 (Week -8) over the BRV Add-On Period and Evaluation Period up to the end of the Re-conversion Follow-up Period (Week 23).
Adverse Event Reporting Description Adverse Events refer to the Intention-to-Treat (ITT) Set consisting of all randomized subjects with at least one intake of study medication.
 
Arm/Group Title Brivaracetam 50 mg/Day Brivaracetam 100 mg/Day
Hide Arm/Group Description Brivaracetam: 25 mg tablet - 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) Brivaracetam: 25 mg tablet - 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 50 mg/Day Brivaracetam 100 mg/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Brivaracetam 50 mg/Day Brivaracetam 100 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/68 (7.35%)      0/20 (0.00%)    
Infections and infestations     
Pneumonia * 1  1/68 (1.47%)  1 0/20 (0.00%)  0
Nervous system disorders     
Grand mal convulsion * 1  2/68 (2.94%)  2 0/20 (0.00%)  0
Dizziness * 1  1/68 (1.47%)  1 0/20 (0.00%)  0
Loss of consciousness * 1  1/68 (1.47%)  1 0/20 (0.00%)  0
Paraesthesia * 1  1/68 (1.47%)  1 0/20 (0.00%)  0
Status epilepticus * 1  1/68 (1.47%)  1 0/20 (0.00%)  0
Psychiatric disorders     
Anxiety * 1  1/68 (1.47%)  1 0/20 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brivaracetam 50 mg/Day Brivaracetam 100 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/68 (48.53%)      10/20 (50.00%)    
Gastrointestinal disorders     
Nausea * 1  3/68 (4.41%)  3 2/20 (10.00%)  3
General disorders     
Fatigue * 1  5/68 (7.35%)  5 2/20 (10.00%)  2
Infections and infestations     
Nasopharyngitis * 1  4/68 (5.88%)  5 1/20 (5.00%)  1
Urinary tract infection * 1  1/68 (1.47%)  1 2/20 (10.00%)  2
Metabolism and nutrition disorders     
Decreased appetite * 1  6/68 (8.82%)  7 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  2/68 (2.94%)  2 2/20 (10.00%)  2
Nervous system disorders     
Headache * 1  9/68 (13.24%)  10 0/20 (0.00%)  0
Convulsion * 1  3/68 (4.41%)  3 4/20 (20.00%)  5
Somnolence * 1  4/68 (5.88%)  4 0/20 (0.00%)  0
Dizziness * 1  0/68 (0.00%)  0 2/20 (10.00%)  2
Psychiatric disorders     
Anxiety * 1  6/68 (8.82%)  6 1/20 (5.00%)  1
Depression * 1  7/68 (10.29%)  7 0/20 (0.00%)  0
Insomnia * 1  5/68 (7.35%)  6 0/20 (0.00%)  0
Vascular disorders     
Hot flush * 1  0/68 (0.00%)  0 2/20 (10.00%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA13.0
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: UCB Cares
Organization: UCB
Phone: +1 877 822 9493
Publications of Results:
Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00698581    
Other Study ID Numbers: N01276
2008-000144-14 ( EudraCT Number )
First Submitted: June 12, 2008
First Posted: June 17, 2008
Results First Submitted: March 14, 2016
Results First Posted: April 13, 2016
Last Update Posted: July 11, 2018