Trial Outcomes & Findings for Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures (NCT NCT01527513)
NCT ID: NCT01527513
Last Updated: 2014-10-24
Results Overview
Power of Attention was defined as the sum of the reaction time measures from the attentional tasks (simple \[dominant hand only\] reaction time, choice reaction time and digit vigilance speed) in order to assess information processing speed and attention/psychomotor speed.Change from baseline to the end of the double-blind period in Power of Attention will be compared between the treatment groups using an ANCOVA. Non-inferiority of ESL vs Placebo will be assessed by comparing the 95% CI's upper bound of the difference of Least Squares Mean (LSmeans) between treatment groups (ESL-placebo) with 121 ms. If the upper bound is greater than 121 ms then the null hypothesis that the change from baseline in the Power of Attention score in ESL group is at least 121 ms inferior than the placebo group will be rejected. Single Values were calculated the average of post treatment visits (visits 5 and 7or EDV) minus average of baseline visits (visits 1 and 2)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
123 participants
Primary outcome timeframe
Visit 1 (-4 weeks for training), Visit 2 (Day 1), Visit 5 (6 weeks), Visit 7 (12 weeks) or at early discontinuation visit (EDV)
Results posted on
2014-10-24
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo Once-Daily (QD)
|
Esl (BIA 2-093)
Eslicarbazepine acetate (BIA 2-093): ESL 10-30 mg/kg/day QD (maximum 1200 mg/day).
|
|---|---|---|
|
Double Blind Period (DB) - Part I
STARTED
|
40
|
83
|
|
Double Blind Period (DB) - Part I
Randomized
|
40
|
83
|
|
Double Blind Period (DB) - Part I
Safety Population
|
40
|
83
|
|
Double Blind Period (DB) - Part I
Entered Maintenance Period
|
40
|
76
|
|
Double Blind Period (DB) - Part I
Completed the Double Blind (DB)- Part I
|
37
|
75
|
|
Double Blind Period (DB) - Part I
Eligible for Open Label Period (OL)
|
37
|
75
|
|
Double Blind Period (DB) - Part I
Efficacy PP Population
|
37
|
67
|
|
Double Blind Period (DB) - Part I
Per-protocol (PP) Population
|
36
|
66
|
|
Double Blind Period (DB) - Part I
COMPLETED
|
37
|
75
|
|
Double Blind Period (DB) - Part I
NOT COMPLETED
|
3
|
8
|
|
Eligible for 1-Year Open Label Period
STARTED
|
0
|
112
|
|
Eligible for 1-Year Open Label Period
COMPLETED
|
0
|
95
|
|
Eligible for 1-Year Open Label Period
NOT COMPLETED
|
0
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Eslicarbazepine Acetate (Esl, Bia 2-093) on Cognitive Function in Children With Partial Onset Seizures
Baseline characteristics by cohort
| Measure |
Esl (BIA 2-093)
n=83 Participants
Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
|
Placebo
n=40 Participants
Placebo QD
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
6-11 Years
|
36 participants
n=5 Participants
|
18 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Age, Customized
12-16 Years
|
47 participants
n=5 Participants
|
22 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
83 participants
n=5 Participants
|
39 participants
n=7 Participants
|
122 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South American
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African (Black)
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (-4 weeks for training), Visit 2 (Day 1), Visit 5 (6 weeks), Visit 7 (12 weeks) or at early discontinuation visit (EDV)Population: The primary analysis was based on the Cognitive Per-protocol (PP) population - all patients in the Modified Cognitive Intent-to-Treat (ITT) population who completed the 8-week maintenance period and were not Important Protocol Deviations (IPDs) with respect to the primary cognitive endpoint.
Power of Attention was defined as the sum of the reaction time measures from the attentional tasks (simple \[dominant hand only\] reaction time, choice reaction time and digit vigilance speed) in order to assess information processing speed and attention/psychomotor speed.Change from baseline to the end of the double-blind period in Power of Attention will be compared between the treatment groups using an ANCOVA. Non-inferiority of ESL vs Placebo will be assessed by comparing the 95% CI's upper bound of the difference of Least Squares Mean (LSmeans) between treatment groups (ESL-placebo) with 121 ms. If the upper bound is greater than 121 ms then the null hypothesis that the change from baseline in the Power of Attention score in ESL group is at least 121 ms inferior than the placebo group will be rejected. Single Values were calculated the average of post treatment visits (visits 5 and 7or EDV) minus average of baseline visits (visits 1 and 2)
Outcome measures
| Measure |
Placebo
n=34 Participants
Placebo QD
|
Esl (BIA 2-093)
n=60 Participants
Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
|
|---|---|---|
|
Change From Baseline in Power of Attention Score to the End of the Double Blind (DB) Period
|
111.085 Milli seconds (ms)
Standard Error 76.4254
|
59.122 Milli seconds (ms)
Standard Error 52.0904
|
SECONDARY outcome
Timeframe: Baseline; Titration Period (4 Weeks: V2-V3-V4)Population: Modified Efficacy ITT population - all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.
Outcome measures
| Measure |
Placebo
n=40 Participants
Placebo QD
|
Esl (BIA 2-093)
n=83 Participants
Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
|
|---|---|---|
|
Change From Baseline in Standardized Seizure Frequency - Part I
|
-9.13 Seizures per week
Standard Deviation 75.602
|
-31.03 Seizures per week
Standard Deviation 87.963
|
SECONDARY outcome
Timeframe: Weeks 1 to ≥ 41 weeksPopulation: Modified Efficacy Intent-to-Treat (ITT) population- all randomized patients who received at least one dose of study treatment after randomization and had at least one post-baseline seizure frequency assessment.
Overall Change from Baseline in Seizure Frequency per week for the One-Year Open-Label Period
Outcome measures
| Measure |
Placebo
n=112 Participants
Placebo QD
|
Esl (BIA 2-093)
Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
|
|---|---|---|
|
Change From Baseline in Seizure Frequency During the One-year Open-Label (OL)
|
-3.03 Seizure per week
Standard Error 31.370
|
—
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Part I - ESL
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Part II - ESL
Serious events: 8 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=40 participants at risk
Placebo QD
|
Part I - ESL
n=83 participants at risk
Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
|
Part II - ESL
n=112 participants at risk
Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
|
|---|---|---|---|
|
Infections and infestations
ACUTE BRONCHITIS
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Nervous system disorders
INCREASED SEIZURE FREQUENCY OF COMPLEX MOTOR PARTIAL SEIZURES
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Injury, poisoning and procedural complications
FRACTURE OF NOSE
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Metabolism and nutrition disorders
TYPE 1 DIABETES MELLITUS
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Cardiac disorders
MITRALIC INSUFFICIENCY
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Nervous system disorders
COMPLEX PARTIAL STATUS
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Infections and infestations
Hepatitis infectious mononucleosis
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Nervous system disorders
Convulsion
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
2.7%
3/112 • throughout the study
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
Other adverse events
| Measure |
Placebo
n=40 participants at risk
Placebo QD
|
Part I - ESL
n=83 participants at risk
Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
|
Part II - ESL
n=112 participants at risk
Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Vascular disorders
Pallor
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Blood and lymphatic system disorders
Monocytosis
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
1.8%
2/112 • throughout the study
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Hepatitis infectious mononucleosis
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
2.7%
3/112 • throughout the study
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Respiratory tract infection
|
5.0%
2/40 • throughout the study
|
4.8%
4/83 • throughout the study
|
2.7%
3/112 • throughout the study
|
|
Infections and infestations
Rubella
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
1.8%
2/112 • throughout the study
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Nervous system disorders
Convulsion
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
3.6%
4/112 • throughout the study
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Reproductive system and breast disorders
Hypomenorrhoea
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
1.8%
2/112 • throughout the study
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
1.8%
2/112 • throughout the study
|
|
Nervous system disorders
Headache
|
15.0%
6/40 • throughout the study
|
9.6%
8/83 • throughout the study
|
5.4%
6/112 • throughout the study
|
|
Nervous system disorders
Somnolence
|
5.0%
2/40 • throughout the study
|
6.0%
5/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
1/40 • throughout the study
|
6.0%
5/83 • throughout the study
|
3.6%
4/112 • throughout the study
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/40 • throughout the study
|
4.8%
4/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Eye disorders
Diplopia
|
0.00%
0/40 • throughout the study
|
3.6%
3/83 • throughout the study
|
1.8%
2/112 • throughout the study
|
|
Nervous system disorders
Dizziness
|
2.5%
1/40 • throughout the study
|
3.6%
3/83 • throughout the study
|
1.8%
2/112 • throughout the study
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/40 • throughout the study
|
3.6%
3/83 • throughout the study
|
5.4%
6/112 • throughout the study
|
|
Gastrointestinal disorders
Nausea
|
5.0%
2/40 • throughout the study
|
2.4%
2/83 • throughout the study
|
1.8%
2/112 • throughout the study
|
|
General disorders
Pyrexia
|
5.0%
2/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
3.6%
4/112 • throughout the study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
2/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
1.8%
2/112 • throughout the study
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Ear and labyrinth disorders
Deafness
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Endocrine disorders
Hypothalamo-pituitary disorder
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Endocrine disorders
Hypothyroidism
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Eye disorders
Astigmatism
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • throughout the study
|
2.4%
2/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
General disorders
Chest pain
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
General disorders
Feeling abnormal
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
General disorders
Irritability
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Bronchitis
|
2.5%
1/40 • throughout the study
|
2.4%
2/83 • throughout the study
|
2.7%
3/112 • throughout the study
|
|
Infections and infestations
Ear infection
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
1.8%
2/112 • throughout the study
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Hepatitis viral
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Infections and infestations
Influenza
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
2.7%
3/112 • throughout the study
|
|
Infections and infestations
Pharyngitis
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Infections and infestations
Rhinitis
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Infections and infestations
Varicella
|
2.5%
1/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Injury, poisoning and procedural complications
Face injury
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Investigations
Electrocardiogram t wave abnormal
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Investigations
Weight decreased
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Nervous system disorders
Ataxia
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Nervous system disorders
Complex partial seizures
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Nervous system disorders
Mental retardation
|
2.5%
1/40 • throughout the study
|
2.4%
2/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Psychiatric disorders
Anxiety
|
2.5%
1/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Psychiatric disorders
Apathy
|
2.5%
1/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Psychiatric disorders
Insomnia
|
2.5%
1/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Psychiatric disorders
Nervousness
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.5%
1/40 • throughout the study
|
0.00%
0/83 • throughout the study
|
0.89%
1/112 • throughout the study
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.5%
1/40 • throughout the study
|
1.2%
1/83 • throughout the study
|
0.00%
0/112 • throughout the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER