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
PlaceboAdded to current medications
Topiramate 5 mg/kg/d5 mg/kg/d
Topiramate 15 mg/kg/d15 mg/kg/d
Topiramate 25 mg/kg/d25 mg/kg/d

Arm Details

1. Sample size for arm
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
2. Inclusion Criteria
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
3. Exclusion Criteria
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
4. Treatment details
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d

Sample Characteristics

1. Gender, number of male
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
Total
2. Gender, percentage of male
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
Total
3. Age at intervention (mean)
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
Total
4. Age at intervention (SD)
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
Total
5. Age at intervention (range)
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
Total
6. Age at intervention (median)
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
Total
7. Seizure types and/or etiology
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
Total
8. Prior treatment
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
Total
9. Comments
Placebo
Topiramate 5 mg/kg/d
Topiramate 15 mg/kg/d
Topiramate 25 mg/kg/d
Total

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalAdverse EventAcidosis
  • All Participants
  • 20 days
CategoricalAdverse EventAnorexia
  • All Participants
  • 20 days
CategoricalAdverse EventAtaxia
  • All Participants
  • 20 days
CategoricalAdverse EventBronchitis
  • All Participants
  • 20 days
CategoricalAdverse EventBronchospasm
  • All Participants
  • 20 days
CategoricalAdverse EventCoughing
  • All Participants
  • 20 days
CategoricalAdverse EventDermatitis
  • All Participants
  • 20 days
CategoricalAdverse EventDiarrhea
  • All Participants
  • 20 days
CategoricalAdverse EventFever
  • All Participants
  • 20 days
CategoricalAdverse EventInfection viral
  • All Participants
  • 20 days
CategoricalAdverse EventMouth dry
  • All Participants
  • 20 days
CategoricalAdverse EventNervousness
  • All Participants
  • 20 days
CategoricalAdverse EventOtitus media
  • All Participants
  • 20 days
CategoricalAdverse EventPharyngitis
  • All Participants
  • 20 days
CategoricalAdverse EventRhinitis
  • All Participants
  • 20 days
CategoricalAdverse EventSaliva increased
  • All Participants
  • 20 days
CategoricalAdverse EventSkin dry
  • All Participants
  • 20 days
CategoricalAdverse EventSomnolence
  • All Participants
  • 20 days
CategoricalAdverse EventUpper respiratory tract infection
  • All Participants
  • 20 days
CategoricalAdverse EventVomiting
  • All Participants
  • 20 days
CategoricalAdverse EventWeight decrease
  • All Participants
  • 20 days
CategoricalAdverse EventWithdrawal due to AE
  • All Participants
  • 20 days
CategoricalAdverse EventTreatment-emergent serious adverse event
  • All Participants
  • 20 days

Outcome Details

1. For RCTs: Generation of randomization sequence
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2. For RCTs: Allocation concealment
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3. For RCTs: Baseline imbalance
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4. For RCTs: Patient blinded
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5. For RCTs: Staff blinded
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6. For RCTs: Differential ancillary treatments
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7. For RCTs: Adherence
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8. For RCTs: Analytic approach to address departures from intended intervention
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9. For RCTs: Data on at least 80% of those enrolled
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10. For RCTs: Differential dropout <=15%
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11. For RCTs: Standard way to measure the outcome
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12. For RCTs: Blinded outcome assessor
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13. For RCTs: Bias in selection of reported results
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14. For nonrandomized comparative studies: Confounding
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15. For nonrandomized comparative studies: Selection into study
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16. For nonrandomized comparative studies: Classification of interventions
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17. For nonrandomized comparative studies: Differential ancillary treatments
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18. For nonrandomized comparative studies: Adherence
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19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
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20. For nonrandomized comparative studies: Differential dropout <=15%
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21. For nonrandomized comparative studies: Standard way to measure the outcome
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22. For nonrandomized comparative studies: Blinded outcome assessor
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23. For nonrandomized comparative studies: Bias in selection of reported result
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24. For single arm studies: Does the design or analysis control account for important confounding and modifying variables through matching, stratification, multivariable analysis, or other approaches?
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25. For single arm studies: Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results?
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26. For single arm studies: Did the study maintain fidelity to the intervention protocol?
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27. For single arm studies: If attrition (overall or differential nonresponse, dropout, loss to follow-up, or exclusion of participants) was a concern, were missing data handled appropriately (e.g., intention-to-treat analysis and imputation)?
Adverse Event
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28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?
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29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?
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30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?
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31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?
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32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?
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Risk of Bias Assessment

1. For Risk of Bias Assessment results, see Outcome Details section.

Results

Categorical


Adverse Event (Acidosis)

All Participants
Descriptive StatisticsBetween Arm Comparisons
PlaceboTopiramate 5 mg/kg/dTopiramate 15 mg/kg/dTopiramate 25 mg/kg/d
20 days
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
PlaceboTopiramate 5 mg/kg/dTopiramate 15 mg/kg/dTopiramate 25 mg/kg/d

Adverse Event (Anorexia)

All Participants
Descriptive StatisticsBetween Arm Comparisons
PlaceboTopiramate 5 mg/kg/dTopiramate 15 mg/kg/dTopiramate 25 mg/kg/d
20 days
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
PlaceboTopiramate 5 mg/kg/dTopiramate 15 mg/kg/dTopiramate 25 mg/kg/d

Adverse Event (Ataxia)

All Participants
Descriptive StatisticsBetween Arm Comparisons
PlaceboTopiramate 5 mg/kg/dTopiramate 15 mg/kg/dTopiramate 25 mg/kg/d
20 days
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
PlaceboTopiramate 5 mg/kg/dTopiramate 15 mg/kg/dTopiramate 25 mg/kg/d

Adverse Event (Bronchitis)

All Participants
Descriptive StatisticsBetween Arm Comparisons
PlaceboTopiramate 5 mg/kg/dTopiramate 15 mg/kg/dTopiramate 25 mg/kg/d
20 days
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
PlaceboTopiramate 5 mg/kg/dTopiramate 15 mg/kg/dTopiramate 25 mg/kg/d

Adverse Event (Bronchospasm)

All Participants
Descriptive StatisticsBetween Arm Comparisons
PlaceboTopiramate 5 mg/kg/dTopiramate 15 mg/kg/dTopiramate 25 mg/kg/d
20 days
Total (N analyzed)
Odds Ratio (OR)
Events