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Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00088452
Recruitment Status : Completed
First Posted : July 27, 2004
Results First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Childhood Absence Epilepsy
Petit Mal Epilepsy
Epilepsy
Seizures
Interventions Drug: Ethosuximide
Drug: Lamotrigine
Drug: Valproic acid
Enrollment 453
Recruitment Details Enrollment occurred from July 2004 through October 2007
Pre-assignment Details  
Arm/Group Title Ethosuximide Lamotrigine Valproic Acid
Hide Arm/Group Description

Ethosuximide

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup

Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)

Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy.

Lamotrigine

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets

Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).

Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy.

Valproic acid

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.

Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)

Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy.

Period Title: Overall Study
Started 156 149 148
Completed 155 149 147
Not Completed 1 0 1
Reason Not Completed
Did not receive intervention             1             0             1
Arm/Group Title Ethosuximide Lamotrigine Valproic Acid Total
Hide Arm/Group Description

Ethosuximide

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup

Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)

Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy.

Lamotrigine

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets

Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).

Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy.

Valproic acid

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.

Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)

Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy.

Total of all reporting groups
Overall Number of Baseline Participants 155 149 147 451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 149 participants 147 participants 451 participants
<=18 years
155
 100.0%
149
 100.0%
147
 100.0%
451
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 149 participants 147 participants 451 participants
Female
90
  58.1%
92
  61.7%
76
  51.7%
258
  57.2%
Male
65
  41.9%
57
  38.3%
71
  48.3%
193
  42.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 149 participants 147 participants 451 participants
American Indian or Alaska Native
1
   0.6%
0
   0.0%
1
   0.7%
2
   0.4%
Asian
0
   0.0%
2
   1.3%
0
   0.0%
2
   0.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
32
  20.6%
26
  17.4%
29
  19.7%
87
  19.3%
White
110
  71.0%
117
  78.5%
107
  72.8%
334
  74.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
12
   7.7%
4
   2.7%
10
   6.8%
26
   5.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 155 participants 149 participants 147 participants 451 participants
155 149 147 451
BMI > 90th percentile for age   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 149 participants 147 participants 451 participants
43
  27.7%
44
  29.5%
33
  22.4%
120
  26.6%
[1]
Measure Description: BMI > 90th percentile for age using the units of kg/m2
1.Primary Outcome
Title Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy
Hide Description Treatment failure was defined as persistence of absence seizures at week 16 or week 20, a generalized tonic-clonic seizure at any time, excessive drug-related systemic toxicity, a moderately severe rash (possibly drug-related), pancreatitis, or increase in the body-mass index of at least 3.0 from baseline, dose-limiting toxicity after a single downward dose modification, or withdrawal initiated by the parent or physician.
Time Frame First 16-20 weeks of double blind therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ethosuximide Lamotrigine Valproic Acid
Hide Arm/Group Description:

Ethosuximide

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup

Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)

Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy.

Lamotrigine

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets

Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).

Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy.

Valproic acid

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.

Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)

Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy.

Overall Number of Participants Analyzed 154 146 146
Measure Type: Count of Participants
Unit of Measure: Participants
81
  52.6%
43
  29.5%
85
  58.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ethosuximide, Lamotrigine
Comments Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.66
Confidence Interval (2-Sided) 95%
1.65 to 4.28
Estimation Comments odds ratio with ethosuximide vs. lamotrigine
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lamotrigine, Valproic Acid
Comments Calculations of sample size were based on the ability to detect a 20% difference in freedom-from failure rates (three pairwise comparisons) at 16 weeks with 80% power at a two-sided P value of 0.017 and one interim analysis. Sample size of 398 was increased to 446 subjects to account for two stratification factors and a 5% dropout rate; this sample size allowed the detection of a difference of 0.5 SD in the Confidence Index on the Conners' Continuous Performance Test with a power exceeding 80%.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.34
Confidence Interval (2-Sided) 95%
2.06 to 5.42
Estimation Comments odds ratio with valproic acid vs. lamotrigine
2.Secondary Outcome
Title Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT
Hide Description A Confidence Index of 0.60 or higher on the Conners' Continuous Performance Test at the visit at 16 or 20 weeks or at an earlier visit when treatment was discontinued (as long as the discontinuation occurred 1 month or more after the baseline visit and was not due to intolerable adverse events). A Confidence Index of 0.60 corresponds to a 60% probability that the child has clinical attention deficit disorder.
Time Frame First 16-20 weeks of double blind therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Those subject who took the Conners' Continuous Performance Test at the visit at 16 or 20 weeks or at an earlier visit when treatment was discontinued (as long as the discontinuation occurred 1 month or more after the baseline visit and was not due to intolerable adverse events).
Arm/Group Title Ethosuximide Lamotrigine Valproic Acid
Hide Arm/Group Description:

Ethosuximide

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup

Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)

Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy.

Lamotrigine

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets

Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).

Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy.

Valproic acid

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.

Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)

Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy.

Overall Number of Participants Analyzed 106 104 106
Measure Type: Count of Participants
Unit of Measure: Participants
35
  33.0%
25
  24.0%
52
  49.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ethosuximide, Valproic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.95
Confidence Interval (2-Sided) 95%
1.12 to 3.41
Estimation Comments Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the ethosuximide group
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lamotrigine, Valproic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.04
Confidence Interval (2-Sided) 95%
1.69 to 5.49
Estimation Comments Percentage of subjects with a Confidence Index score of 0.60 or higher in the valproic acid group than in the lamotrigine group
3.Secondary Outcome
Title Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy
Hide Description Treatment failure was defined as persistence of absence seizures at 12 months of double blind therapy, a generalized tonic-clonic seizure at any time, excessive drug-related systemic toxicity, a moderately severe rash (possibly drug-related), pancreatitis, or increase in the body-mass index of at least 3.0 from baseline, dose-limiting toxicity after a single downward dose modification, or withdrawal initiated by the parent or physician.
Time Frame First 12 months of double blind therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ethosuximide Lamotrigine Valproic Acid
Hide Arm/Group Description:

Ethosuximide

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup

Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)

Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy.

Lamotrigine

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets

Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).

Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy.

Valproic acid

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.

Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)

Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy.

Overall Number of Participants Analyzed 154 146 146
Measure Type: Count of Participants
Unit of Measure: Participants
70
  45.5%
31
  21.2%
64
  43.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ethosuximide, Lamotrigine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.08
Confidence Interval (2-Sided) 95%
1.81 to 5.33
Estimation Comments Odds ratio for FFF for ethosuximide versus lamotrigine
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lamotrigine, Valproic Acid
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.88
Confidence Interval (2-Sided) 95%
1.68 to 5.02
Estimation Comments odds ratio for FFF for valproic acid versus lamotrigine
Time Frame Adverse event data was collected over 3.5 years
Adverse Event Reporting Description The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
 
Arm/Group Title Ethosuximide Lamotrigine Valproic Acid
Hide Arm/Group Description

Ethosuximide

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup

Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)

Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy.

Lamotrigine

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Three formulations were used (actual formulation used was dependent on the patient's weight): 5mg Lamictal chewable tablets OR 25 mg Lamictal chewable tablets OR 25 mg (Lamictal tablets

Dosing: Lamotrigine was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 12 mg/kg/day or 600 mg/day (whichever was lower).

Lamotrigine: Lamotrigine is a common treatment for childhood absence epilepsy.

Valproic acid

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight): 250mg Depakote capsules OR 125mg Depakote sprinkles.

Dosing: Depakote was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 3000 mg/day (whichever was lower)

Valproic acid: Valproic acid is a common treatment for childhood absence epilepsy.

All-Cause Mortality
Ethosuximide Lamotrigine Valproic Acid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/155 (0.00%)      0/149 (0.00%)      0/147 (0.00%)    
Hide Serious Adverse Events
Ethosuximide Lamotrigine Valproic Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/155 (2.58%)      2/149 (1.34%)      2/147 (1.36%)    
Infections and infestations       
Enteritis  [1]  0/155 (0.00%)  0 1/149 (0.67%)  1 0/147 (0.00%)  0
Nervous system disorders       
Generalized tonic clonic seizure   2/155 (1.29%)  2 0/149 (0.00%)  0 1/147 (0.68%)  1
Prolonged Absence Seizure   0/155 (0.00%)  0 1/149 (0.67%)  1 0/147 (0.00%)  0
Pneumonia, diarrhea, vomiting   1/155 (0.65%)  1 0/149 (0.00%)  0 0/147 (0.00%)  0
Psychiatric disorders       
Non-epileptic movements   1/155 (0.65%)  1 0/149 (0.00%)  0 0/147 (0.00%)  0
Acting Out  [2]  0/155 (0.00%)  0 0/149 (0.00%)  0 1/147 (0.68%)  1
Indicates events were collected by systematic assessment
[1]
Due to Salmonella poisoning
[2]
Voluntarily committed
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ethosuximide Lamotrigine Valproic Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   103/155 (66.45%)      78/149 (52.35%)      100/147 (68.03%)    
Gastrointestinal disorders       
Nausea, vomiting, or both   23/155 (14.84%)  23 2/149 (1.34%)  2 10/147 (6.80%)  10
Stomach upset   16/155 (10.32%)  16 4/149 (2.68%)  4 8/147 (5.44%)  8
Increased appetite   5/155 (3.23%)  5 7/149 (4.70%)  7 13/147 (8.84%)  13
Decreased appetite   8/155 (5.16%)  8 5/149 (3.36%)  5 3/147 (2.04%)  3
Weight increase   1/155 (0.65%)  1 3/149 (2.01%)  3 10/147 (6.80%)  10
General disorders       
Fatigue   15/155 (9.68%)  15 13/149 (8.72%)  13 18/147 (12.24%)  18
Headache   19/155 (12.26%)  19 12/149 (8.05%)  12 12/147 (8.16%)  12
Sleep problem   10/155 (6.45%)  10 5/149 (3.36%)  5 14/147 (9.52%)  14
Nervous system disorders       
Decrease in concentration   6/155 (3.87%)  6 5/149 (3.36%)  5 11/147 (7.48%)  11
Somnolence   14/155 (9.03%)  14 3/149 (2.01%)  3 4/147 (2.72%)  4
Attentional difficulties   3/155 (1.94%)  3 5/149 (3.36%)  5 10/147 (6.80%)  10
Dizziness   9/155 (5.81%)  9 4/149 (2.68%)  4 2/147 (1.36%)  2
Memory problems   0/155 (0.00%)  0 4/149 (2.68%)  4 8/147 (5.44%)  8
Psychiatric disorders       
Hyperactivity   14/155 (9.03%)  14 10/149 (6.71%)  10 15/147 (10.20%)  15
Hostility   4/155 (2.58%)  4 10/149 (6.71%)  10 18/147 (12.24%)  18
Personality change   4/155 (2.58%)  4 9/149 (6.04%)  9 16/147 (10.88%)  16
Depression   4/155 (2.58%)  4 8/149 (5.37%)  8 8/147 (5.44%)  8
Indicates events were collected by systematic assessment
This short-term study was not designed to detect long-term systemic or other cognitive effects of these three medications.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
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Name/Title: Tracy Glauser, MD
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513-636-8854
EMail: tracy.glauser@cchmc.org
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT00088452    
Other Study ID Numbers: U01NS045911 ( U.S. NIH Grant/Contract )
U01NS045803 ( U.S. NIH Grant/Contract )
First Submitted: July 26, 2004
First Posted: July 27, 2004
Results First Submitted: August 21, 2020
Results First Posted: October 14, 2020
Last Update Posted: October 14, 2020