Trial Outcomes & Findings for Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children (NCT NCT00988156)
NCT ID: NCT00988156
Last Updated: 2018-11-13
Results Overview
Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
304 participants
Primary outcome timeframe
Baseline up to Visit 7
Results posted on
2018-11-13
Participant Flow
73 clinical centres in 20 countries Date first patient enrolled: 07 Dec 2007. Date last patient completed the double-blind treatment period (Part I): 20 Aug 2012.
Participant milestones
| Measure |
Placebo
Placebo matching placebo
|
Esl (BIA 2-093)
Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
|
|---|---|---|
|
Overall Study
STARTED
|
149
|
155
|
|
Overall Study
Intention-to-Treat Set (ITT)
|
129
|
134
|
|
Overall Study
Per Protocol Set (PP)
|
101
|
97
|
|
Overall Study
Safety Set
|
129
|
134
|
|
Overall Study
COMPLETED
|
132
|
135
|
|
Overall Study
NOT COMPLETED
|
17
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children
Baseline characteristics by cohort
| Measure |
Placebo
n=129 Participants
Placebo matching placebo
|
Esl (BIA 2-093)
n=134 Participants
Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL or matching placebo. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
|
Total
n=263 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
2-6 years
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Age, Customized
7-11 years
|
53 participants
n=5 Participants
|
51 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Age, Customized
12-18 years
|
45 participants
n=5 Participants
|
52 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Visit 7Relative reduction in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
Outcome measures
| Measure |
Placebo
n=129 Participants
Placebo matching placebo
|
Esl (BIA 2-093)
n=134 Participants
Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
|
|---|---|---|
|
Change From Baseline in Seizure Frequency
|
62.0 seizures/month
Standard Deviation 186.19
|
36.6 seizures/month
Standard Deviation 72.47
|
PRIMARY outcome
Timeframe: baseline up to Visit 7Responder rate defined as the number of patients with at least a 50% decrease in the standardised 4-week seizure frequency from the baseline period to the 12-week maintenance period.
Outcome measures
| Measure |
Placebo
n=129 Participants
Placebo matching placebo
|
Esl (BIA 2-093)
n=134 Participants
Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
|
|---|---|---|
|
Responder Rate
|
40 participants
|
41 participants
|
Adverse Events
Placebo (Safety Set Part I)
Serious events: 9 serious events
Other events: 94 other events
Deaths: 0 deaths
Esl (Safety Set Part I)
Serious events: 15 serious events
Other events: 112 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Safety Set Part I)
n=129 participants at risk
|
Esl (Safety Set Part I)
n=134 participants at risk
|
|---|---|---|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Gastrointestinal disorders
COELIAC DISEASE
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
General disorders
DEVICE MALFUNCTION
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
1.5%
2/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
General disorders
IRRITABILITY
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.00%
0/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
1.5%
2/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
INFECTIOUS MONONUCLEOSIS
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
PNEUMONIA
|
2.3%
3/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Injury, poisoning and procedural complications
BRAIN HERNIATION
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
CONVULSION
|
1.6%
2/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
1.5%
2/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
EPILEPSY
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
HYDROCEPHALUS
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.00%
0/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
HYPOTONIA
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.00%
0/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
PARTIAL SEIZURES WITH SECONDARY GENERALISATION
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
STATUS EPILEPTICUS
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
2.2%
3/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Respiratory, thoracic and mediastinal disorders
ASPHYXIA
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.00%
0/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Skin and subcutaneous tissue disorders
VASCULAR PURPURA
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.75%
1/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Surgical and medical procedures
MEDICAL DEVICE CHANGE
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
0.00%
0/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
Other adverse events
| Measure |
Placebo (Safety Set Part I)
n=129 participants at risk
|
Esl (Safety Set Part I)
n=134 participants at risk
|
|---|---|---|
|
Nervous system disorders
Headache
|
6.2%
8/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
13.4%
18/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
Nasopharyngitis
|
34.9%
45/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
11.2%
15/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
Somnolence
|
4.7%
6/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
11.2%
15/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
Convulsion
|
10.9%
14/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
9.7%
13/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
General disorders
Pyrexia
|
5.4%
7/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
7.5%
10/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
Pharyngitis
|
7.0%
9/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
6.7%
9/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Eye disorders
Diplopia
|
1.6%
2/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
6.0%
8/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
8/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
6.0%
8/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Gastrointestinal disorders
Nausea
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
5.2%
7/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
Respiratory tract infection
|
5.4%
7/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
5.2%
7/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
4.5%
6/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
5/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
4.5%
6/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
4.5%
6/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
Viral infection
|
4.7%
6/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
4.5%
6/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Psychiatric disorders
Agitation
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
3.7%
5/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
Bronchitis
|
5.4%
7/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
3.7%
5/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Nervous system disorders
Dizziness
|
1.6%
2/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
3.7%
5/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
General disorders
Fatigue
|
2.3%
3/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
3.7%
5/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.3%
3/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
3.7%
5/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Investigations
Weight increased
|
1.6%
2/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
3.7%
5/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
3.0%
4/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
Influenza
|
0.78%
1/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
3.0%
4/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Infections and infestations
Rhinitis
|
5.4%
7/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
3.0%
4/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
4/129 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
2.2%
3/134 • from the time the patient gave informed consent until 14 days after the end of the follow-up period for Part I
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER