Trial Outcomes & Findings for Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study (NCT NCT00088452)
NCT ID: NCT00088452
Last Updated: 2020-10-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
453 participants
Primary outcome timeframe
First 16-20 weeks of double blind therapy
Results posted on
2020-10-14
Participant Flow
Enrollment occurred from July 2004 through October 2007
Participant milestones
| Measure |
Ethosuximide
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
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
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 Study
STARTED
|
156
|
149
|
148
|
|
Overall Study
COMPLETED
|
155
|
149
|
147
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Ethosuximide
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
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
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 Study
Did not receive intervention
|
1
|
0
|
1
|
Baseline Characteristics
Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study
Baseline characteristics by cohort
| Measure |
Ethosuximide
n=155 Participants
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
n=149 Participants
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
n=147 Participants
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
n=451 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
155 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
451 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
258 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
110 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
334 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=5 Participants
|
149 participants
n=7 Participants
|
147 participants
n=5 Participants
|
451 participants
n=4 Participants
|
|
BMI > 90th percentile for age
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: First 16-20 weeks of double blind therapyTreatment 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.
Outcome measures
| Measure |
Ethosuximide
n=154 Participants
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
n=146 Participants
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
n=146 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Freedom From Treatment Failure at 16-20 Weeks of Double Blind Therapy
|
81 Participants
|
43 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: First 16-20 weeks of double blind therapyPopulation: 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).
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.
Outcome measures
| Measure |
Ethosuximide
n=106 Participants
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
n=104 Participants
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
n=106 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Attention Deficit as Measured by the Confidence Index of the CPT-II and the K-CPT
|
35 Participants
|
25 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: First 12 months of double blind therapyTreatment 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.
Outcome measures
| Measure |
Ethosuximide
n=154 Participants
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
n=146 Participants
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
n=146 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Freedom From Treatment Failure at 12 Months of Double Blind Therapy
|
70 Participants
|
31 Participants
|
64 Participants
|
Adverse Events
Ethosuximide
Serious events: 4 serious events
Other events: 103 other events
Deaths: 0 deaths
Lamotrigine
Serious events: 2 serious events
Other events: 78 other events
Deaths: 0 deaths
Valproic Acid
Serious events: 2 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ethosuximide
n=155 participants at risk
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
n=149 participants at risk
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
n=147 participants at risk
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.
|
|---|---|---|---|
|
Nervous system disorders
Generalized tonic clonic seizure
|
1.3%
2/155 • Number of events 2 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.00%
0/149 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.68%
1/147 • Number of events 1 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Infections and infestations
Enteritis
|
0.00%
0/155 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.67%
1/149 • Number of events 1 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.00%
0/147 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Nervous system disorders
Prolonged Absence Seizure
|
0.00%
0/155 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.67%
1/149 • Number of events 1 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.00%
0/147 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Nervous system disorders
Pneumonia, diarrhea, vomiting
|
0.65%
1/155 • Number of events 1 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.00%
0/149 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.00%
0/147 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Psychiatric disorders
Non-epileptic movements
|
0.65%
1/155 • Number of events 1 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.00%
0/149 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.00%
0/147 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Psychiatric disorders
Acting Out
|
0.00%
0/155 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.00%
0/149 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
0.68%
1/147 • Number of events 1 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
Other adverse events
| Measure |
Ethosuximide
n=155 participants at risk
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
n=149 participants at risk
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
n=147 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Fatigue
|
9.7%
15/155 • Number of events 15 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
8.7%
13/149 • Number of events 13 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
12.2%
18/147 • Number of events 18 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
General disorders
Headache
|
12.3%
19/155 • Number of events 19 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
8.1%
12/149 • Number of events 12 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
8.2%
12/147 • Number of events 12 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
General disorders
Sleep problem
|
6.5%
10/155 • Number of events 10 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
3.4%
5/149 • Number of events 5 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
9.5%
14/147 • Number of events 14 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Gastrointestinal disorders
Nausea, vomiting, or both
|
14.8%
23/155 • Number of events 23 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
1.3%
2/149 • Number of events 2 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
6.8%
10/147 • Number of events 10 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Gastrointestinal disorders
Stomach upset
|
10.3%
16/155 • Number of events 16 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
2.7%
4/149 • Number of events 4 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
5.4%
8/147 • Number of events 8 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Gastrointestinal disorders
Increased appetite
|
3.2%
5/155 • Number of events 5 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
4.7%
7/149 • Number of events 7 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
8.8%
13/147 • Number of events 13 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Gastrointestinal disorders
Decreased appetite
|
5.2%
8/155 • Number of events 8 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
3.4%
5/149 • Number of events 5 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
2.0%
3/147 • Number of events 3 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Gastrointestinal disorders
Weight increase
|
0.65%
1/155 • Number of events 1 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
2.0%
3/149 • Number of events 3 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
6.8%
10/147 • Number of events 10 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Psychiatric disorders
Hyperactivity
|
9.0%
14/155 • Number of events 14 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
6.7%
10/149 • Number of events 10 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
10.2%
15/147 • Number of events 15 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Psychiatric disorders
Hostility
|
2.6%
4/155 • Number of events 4 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
6.7%
10/149 • Number of events 10 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
12.2%
18/147 • Number of events 18 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Psychiatric disorders
Personality change
|
2.6%
4/155 • Number of events 4 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
6.0%
9/149 • Number of events 9 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
10.9%
16/147 • Number of events 16 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Nervous system disorders
Decrease in concentration
|
3.9%
6/155 • Number of events 6 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
3.4%
5/149 • Number of events 5 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
7.5%
11/147 • Number of events 11 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Nervous system disorders
Somnolence
|
9.0%
14/155 • Number of events 14 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
2.0%
3/149 • Number of events 3 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
2.7%
4/147 • Number of events 4 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Psychiatric disorders
Depression
|
2.6%
4/155 • Number of events 4 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
5.4%
8/149 • Number of events 8 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
5.4%
8/147 • Number of events 8 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Nervous system disorders
Attentional difficulties
|
1.9%
3/155 • Number of events 3 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
3.4%
5/149 • Number of events 5 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
6.8%
10/147 • Number of events 10 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Nervous system disorders
Dizziness
|
5.8%
9/155 • Number of events 9 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
2.7%
4/149 • Number of events 4 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
1.4%
2/147 • Number of events 2 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
|
Nervous system disorders
Memory problems
|
0.00%
0/155 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
2.7%
4/149 • Number of events 4 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
5.4%
8/147 • Number of events 8 • Adverse event data was collected over 3.5 years
The definition of adverse event and/or serious adverse event, used to collect adverse event information, is the same as clinicaltrials.gov defintions
|
Additional Information
Tracy Glauser, MD
Cincinnati Children's Hospital Medical Center
Phone: 513-636-8854
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place