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
StiripentolNot specifically reported for those age 0-2, but for the N=376 new patients, mean starting dose was 13.4 mg/kg/day. After one year, the mean dose was 32.5 mg/kg/day.

Arm Details

1. Sample size for arm
Stiripentol
2. Inclusion Criteria
Stiripentol
3. Exclusion Criteria
Stiripentol
4. Treatment details
Stiripentol

Sample Characteristics

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

Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
Categorical"Marked" or "moderate" improvementPhysicians rated improvement on a 1-5 scale where 1=marked, 2=moderate, 3=mild, 4=no change, 5=worsened. This was based on seizure frequency, duration, intensity, and the ability to undertake activities of daily living.
  • All Participants
  • 2 years
CategoricalAdverse EventAny adverse drug reaction
  • All Participants
  • Two years
CategoricalAdverse EventDeath due to liver damage
  • All Participants
  • Two months

Outcome Details

1. For RCTs: Generation of randomization sequence
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
2. For RCTs: Allocation concealment
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
3. For RCTs: Baseline imbalance
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
4. For RCTs: Patient blinded
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
5. For RCTs: Staff blinded
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
6. For RCTs: Differential ancillary treatments
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
7. For RCTs: Adherence
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
8. For RCTs: Analytic approach to address departures from intended intervention
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
9. For RCTs: Data on at least 80% of those enrolled
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
10. For RCTs: Differential dropout <=15%
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
11. For RCTs: Standard way to measure the outcome
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
12. For RCTs: Blinded outcome assessor
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
13. For RCTs: Bias in selection of reported results
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
14. For nonrandomized comparative studies: Confounding
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
15. For nonrandomized comparative studies: Selection into study
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
16. For nonrandomized comparative studies: Classification of interventions
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
17. For nonrandomized comparative studies: Differential ancillary treatments
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
18. For nonrandomized comparative studies: Adherence
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
19. For nonrandomized comparative studies: Data on at least 80% of those enrolled
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
20. For nonrandomized comparative studies: Differential dropout <=15%
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
21. For nonrandomized comparative studies: Standard way to measure the outcome
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
22. For nonrandomized comparative studies: Blinded outcome assessor
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
23. For nonrandomized comparative studies: Bias in selection of reported result
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
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?
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
25. For single arm studies: Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results?
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
26. For single arm studies: Did the study maintain fidelity to the intervention protocol?
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
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)?
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?
"Marked" or "moderate" improvement
Adverse Event
Adverse Event
32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?
"Marked" or "moderate" improvement
Adverse Event
Adverse Event

Risk of Bias Assessment

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

Results

Categorical


"Marked" or "moderate" improvement (Physicians rated improvement on a 1-5 scale where 1=marked, 2=moderate, 3=mild, 4=no change, 5=worsened. This was based on seizure frequency, duration, intensity, and the ability to undertake activities of daily living.)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Stiripentol
2 years
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Stiripentol

Adverse Event (Any adverse drug reaction)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Stiripentol
Two years
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Stiripentol

Adverse Event (Death due to liver damage)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Stiripentol
Two months
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Stiripentol