Trial Outcomes & Findings for 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 (NCT NCT00699283)
NCT ID: NCT00699283
Last Updated: 2018-07-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
62 participants
Primary outcome timeframe
From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)
Results posted on
2018-07-11
Participant Flow
This multi-Center study started to enroll subjects in August 2008 and concluded in March 2010.
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 Subjects withdrawn due to meeting an exit criterion are included in the count of early discontinuations with a reason of "Adverse Event" or "Lack of efficacy" as reported by the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.
Participant milestones
| Measure |
Brivaracetam (BRV) 50 mg
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 (BRV) 100 mg
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 Study
STARTED
|
47
|
15
|
|
Overall Study
COMPLETED
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
33
|
8
|
Reasons for withdrawal
| Measure |
Brivaracetam (BRV) 50 mg
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 (BRV) 100 mg
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 Study
Lack of Efficacy
|
15
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Other Reason
|
5
|
1
|
|
Overall Study
SAE, non-fatal
|
1
|
1
|
|
Overall Study
AE, non-serious non-fatal
|
8
|
1
|
|
Overall Study
AE of unknown type
|
1
|
0
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Brivaracetam (BRV) 50 mg
n=47 Participants
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 (BRV) 100 mg
n=15 Participants
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).
|
Total Title
n=62 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 Years
|
45 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 15.9 • n=7 Participants
|
40.3 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)Population: 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
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.
Outcome measures
| Measure |
Efficacy Set (Brivaracetam 50 mg Treated Subjects)
n=45 Participants
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.
|
|---|---|
|
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
|
0.474 percentage of subjects
Interval 0.31 to 0.638
|
Adverse Events
Brivaracetam (BRV) 50 mg
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
Brivaracetam (BRV) 100 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brivaracetam (BRV) 50 mg
n=47 participants at risk
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 (BRV) 100 mg
n=15 participants at risk
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).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Intentional overdose
|
2.1%
1/47 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Nervous system disorders
Epilepsy
|
2.1%
1/47 • Number of events 4 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Nervous system disorders
Status epilepticus
|
2.1%
1/47 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Psychiatric disorders
Suicide attempt
|
2.1%
1/47 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
Other adverse events
| Measure |
Brivaracetam (BRV) 50 mg
n=47 participants at risk
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 (BRV) 100 mg
n=15 participants at risk
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).
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/47 • Number of events 2 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
3/47 • Number of events 3 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
General disorders
Fatigue
|
8.5%
4/47 • Number of events 4 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
13.3%
2/15 • Number of events 2 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
General disorders
Irritability
|
10.6%
5/47 • Number of events 6 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
General disorders
Asthenia
|
8.5%
4/47 • Number of events 4 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
General disorders
Chest pain
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
2.1%
1/47 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 2 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Investigations
White blood cells urine positive
|
2.1%
1/47 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.1%
1/47 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
13.3%
2/15 • Number of events 2 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Nervous system disorders
Dizziness
|
14.9%
7/47 • Number of events 8 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
13.3%
2/15 • Number of events 2 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Nervous system disorders
Convulsion
|
10.6%
5/47 • Number of events 11 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
13.3%
2/15 • Number of events 2 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Nervous system disorders
Headache
|
8.5%
4/47 • Number of events 5 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Nervous system disorders
Grand mal convulsion
|
6.4%
3/47 • Number of events 4 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Psychiatric disorders
Depression
|
6.4%
3/47 • Number of events 3 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
13.3%
2/15 • Number of events 2 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Psychiatric disorders
Anxiety
|
8.5%
4/47 • Number of events 5 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Psychiatric disorders
Insomnia
|
8.5%
4/47 • Number of events 4 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.4%
3/47 • Number of events 3 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
0.00%
0/15 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/47 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
6.7%
1/15 • Number of events 1 • 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 Events refer to the Intent-to-Treat (ITT) Set, consisting of all randomized subjects with at least 1 intake of study medication.
|
Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60