Extraction form for project: Management of Infantile Epilepsies

Design Details

1. Study Design
2. Country
3. Total sample size
4. Intervention Type
5. Funding source

Arms

Arm NameArm Description
LamotrigineMaximum maintenance dose 5.1 mg/kg/day for those on either valproate or a non-enzyme-inducing ASM, or 15.6 mg/kg/day for those on enzyme-inducing ASM.
Replacement of lamotrigine with placebo

Arm Details

1. Sample size for arm
Lamotrigine
Replacement of lamotrigine with placebo
2. Inclusion Criteria
Lamotrigine
Replacement of lamotrigine with placebo
3. Exclusion Criteria
Lamotrigine
Replacement of lamotrigine with placebo
4. Treatment details
Lamotrigine
Replacement of lamotrigine with placebo

Sample Characteristics

1. Gender, number of male
Lamotrigine
Replacement of lamotrigine with placebo
Total
2. Gender, percentage of male
Lamotrigine
Replacement of lamotrigine with placebo
Total
3. Age at intervention (mean)
Lamotrigine
Replacement of lamotrigine with placebo
Total
4. Age at intervention (SD)
Lamotrigine
Replacement of lamotrigine with placebo
Total
5. Age at intervention (range)
Lamotrigine
Replacement of lamotrigine with placebo
Total
6. Age at intervention (median)
Lamotrigine
Replacement of lamotrigine with placebo
Total
7. Seizure types and/or etiology
Lamotrigine
Replacement of lamotrigine with placebo
Total
8. Prior treatment
Lamotrigine
Replacement of lamotrigine with placebo
Total
9. Comments
Lamotrigine
Replacement of lamotrigine with placebo
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalSeizure freedom
  • All Participants
  • >=24 weeks in 92%
CategoricalSeizure reduction/effective (>50% reduction)
  • All Participants
  • >=24 weeks in 92%
CategoricalSeizure increase (26-49% increase)
  • All Participants
  • >=24 weeks in 92%
CategoricalSeizure increase (>=50% increase)
  • All Participants
  • >=24 weeks in 92%
CategoricalPercent reduction in seizures from baseline
  • All Participants
  • >=24 weeks in 92%
CategoricalAdverse EventAny rash
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventBronchitis
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventComplex partial seizure
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventConstipation
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventCough
  • All Participants
  • 8 weeks
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventDermatitis diaper
  • All Participants
  • >5 weeks
CategoricalAdverse EventDiarrhea
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventEar infection
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventInsomnia
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventNasal congestion
  • All Participants
  • 8 weeks
  • >5 weeks
CategoricalAdverse EventIrritability
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventNasopharyngitis
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventOtitis media
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventPharyngitis
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventPneumonia
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventFever
  • All Participants
  • 8 weeks
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventSerious event: apnea
  • All Participants
  • >5 weeks
CategoricalAdverse EventSerious event: complex partial seizures
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventSerious event: convulsions
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventSerious event: cyanosis
  • All Participants
  • >5 weeks
CategoricalAdverse EventSerious event: partial seizures with secondary generalization
  • All Participants
  • >5 weeks
CategoricalAdverse EventSerious event: pneumonia
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventSerious event: status epilepticus
  • All Participants
  • 8 weeks
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventSomnolence
  • All Participants
  • >5 weeks
CategoricalAdverse EventTeething
  • All Participants
  • 8 weeks
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventUpper respiratory tract congestion
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventUpper respiratory tract infection
  • All Participants
  • 8 weeks
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventVomiting
  • All Participants
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventWithdrawal due to AE
  • All Participants
  • 8 weeks
  • >=24 weeks in 92%
  • >5 weeks
CategoricalAdverse EventConvulsion
  • All Participants
  • >=24 weeks in 92%
CategoricalAdverse EventGastroenteritis
  • All Participants
  • >=24 weeks in 92%
CategoricalAdverse EventSerious event: dehydration
  • All Participants
  • >=24 weeks in 92%
CategoricalAdverse EventSerious event: fever
  • All Participants
  • >=24 weeks in 92%
CategoricalAdverse EventSerious event: gastroenteritis
  • All Participants
  • >=24 weeks in 92%
CategoricalAdverse EventStatus epilepticus
  • All Participants
  • >=24 weeks in 92%
CategoricalAdverse EventRespiratory tract infection
  • All Participants
  • >=24 weeks in 92%
CategoricalAdverse EventViral infection
  • All Participants
  • >=24 weeks in 92%
CategoricalAdverse EventRash (moderate intensity)
  • All Participants
  • 8 weeks
CategoricalAdverse EventSerious event: bronchitis
  • All Participants
  • 8 weeks

Outcome Details

1. For RCTs: Generation of randomization sequence
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
2. For RCTs: Allocation concealment
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
3. For RCTs: Baseline imbalance
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
4. For RCTs: Patient blinded
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
5. For RCTs: Staff blinded
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
6. For RCTs: Differential ancillary treatments
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
7. For RCTs: Adherence
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
8. For RCTs: Analytic approach to address departures from intended intervention
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
9. For RCTs: Data on at least 80% of those enrolled
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
10. For RCTs: Differential dropout <=15%
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
11. For RCTs: Standard way to measure the outcome
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
12. For RCTs: Blinded outcome assessor
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
13. For RCTs: Bias in selection of reported results
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
14. For nonrandomized comparative studies: Confounding
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
15. For nonrandomized comparative studies: Selection into study
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
16. For nonrandomized comparative studies: Classification of interventions
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
17. For nonrandomized comparative studies: Differential ancillary treatments
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
18. For nonrandomized comparative studies: Adherence
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
Adverse Event
19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
Seizure freedom
Seizure reduction/effective (>50% reduction)
Seizure increase (26-49% increase)
Seizure increase (>=50% increase)
Percent reduction in seizures from baseline
Adverse Event
Adverse Event
Adverse Event
Adverse Event