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Design Details
Arms
Arm Details
Sample Characteristics
Outcomes
Outcome Details
Risk of Bias Assessment
Results
Print Data

Extraction form for project: Management of Infantile Epilepsies

Design Details

1. Study Design


	RCT Nonrandomized comparative study Pre/post observational study

2. Country


	USA

3. Total sample size


	103

4. Intervention Type


	Pharmacological Dietary Surgery

5. Funding source


	Lundbeck Inc. (manufacturer of the tested medication)

Arms

Arm Name	Arm Description
Vigabatrin	The median dose at first follow-up was 100 mg/kg per day (IQR 79.4–125) and at last follow-up was 93.8 mg/kg per day (IQR 54–128.6).

Arm Details

1. Sample size for arm

Vigabatrin


	103

2. Inclusion Criteria

Vigabatrin


	Diagnosed with epilepsy, electronic medical record available, treated with vigabatrin at Boston Children's over a 2-year period

3. Exclusion Criteria

Vigabatrin


	Excluded patients whose vigabatrin initiation date was unavailable, whose baseline seizure frequency was unavailable, or whose followup seizure frequency was unavailable, or whose data were incomplete.

4. Treatment details

Vigabatrin


	Median dose at first followup was 100 mg/kg per day (IQR 79.4–125) and at last followup was 93.8 mg/kg per day (IQR 54-128.6).

Sample Characteristics

1. Gender, number of male

Vigabatrin


	48

2. Gender, percentage of male

Vigabatrin


	47

3. Age at intervention (mean)

Vigabatrin


	8 months

4. Age at intervention (SD)

Vigabatrin


	NR

5. Age at intervention (range)

Vigabatrin


	IQR 5-15 months

6. Age at intervention (median)

Vigabatrin


	NR

7. Seizure types and/or etiology

Vigabatrin


	Structural/metabolic 49.5%, TSC 24%, malformation of cortical development 18%, other 8%. 91% "epileptic spasm", 15% focal, 10% generalized tonic, 5% generalized myoclonic, 5% generalized tonic-clonic, 4% generalized atonic, and 1% generalized absence.

8. Prior treatment

Vigabatrin


	Concomitant treatments were levetiracetam in 35%, topiramate in 31.1%, phenobarbital in 25.2%, clonazepam in 12.6%, clobazam in 10.7%, zonisamide in 9.7%, oxcarbazepine in 6.8%, valproic acid in 5.8%, phenytoin in 1.9%, rufinamide in 1.9%, lacosamide in 1.9%, lorazepam in 1.9%, lamotrigine in 0.97%, tiagabine in 0.97%, gabapentin in 0.97%, pyridoxine in 12%, steroid in 11%, ketogenic diet in 2%.

9. Comments

Vigabatrin


	Boston Children's Hospital, USA

Outcomes

Type	Domain	Specific measurement (i.e., tool/definition/specific outcome)	Populations	Timepoints
Categorical	Seizure freedom		All Participants	Median 12 months
Categorical	Seizure reduction/effective (>50% reduction)		All Participants	Median 12 months
Categorical	Percent reduction in seizures from baseline		All Participants	Median 12 months
Categorical	Adverse Event	Anemia	All Participants	Median 12 months
Categorical	Adverse Event	Anorexia	All Participants	Median 12 months
Categorical	Adverse Event	Fatigue	All Participants	Median 12 months
Categorical	Adverse Event	Medication toxicity	All Participants	Median 12 months
Categorical	Adverse Event	Vigabatrin related toxicity	All Participants	Median 12 months
Categorical	Adverse Event	Vision abnormality	All Participants	Median 12 months
Categorical	Adverse Event	Withdrawal due to AE	All Participants	Median 12 months
Categorical	Adverse Event	Vision abnormality on eye exam	All Participants	Before vigabatrin During vigabatrin After vigabatrin

Outcome Details

1. For RCTs: Generation of randomization sequence

Seizure freedom

Seizure reduction/effective (>50% reduction)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

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)

Percent reduction in seizures from baseline

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

20. For nonrandomized comparative studies: Differential dropout <=15%

Seizure freedom

Seizure reduction/effective (>50% reduction)

Percent reduction in seizures from baseline

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

21. For nonrandomized comparative studies: Standard way to measure the outcome

Seizure freedom

Seizure reduction/effective (>50% reduction)

Percent reduction in seizures from baseline

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

22. For nonrandomized comparative studies: Blinded outcome assessor

Seizure freedom

Seizure reduction/effective (>50% reduction)

Percent reduction in seizures from baseline

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

23. For nonrandomized comparative studies: Bias in selection of reported result

Seizure freedom

Seizure reduction/effective (>50% reduction)

Percent reduction in seizures from baseline

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

Adverse Event

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?

Seizure freedom


	Some concerns

Seizure reduction/effective (>50% reduction)


	Some concerns

Percent reduction in seizures from baseline

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

25. For single arm studies: Did researchers rule out any impact from a concurrent intervention or an unintended exposure that might bias results?

Seizure freedom


	High

Seizure reduction/effective (>50% reduction)


	High

Percent reduction in seizures from baseline

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

26. For single arm studies: Did the study maintain fidelity to the intervention protocol?

Seizure freedom


	Low

Seizure reduction/effective (>50% reduction)


	Low

Percent reduction in seizures from baseline

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

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)?

Seizure freedom


	Low

Seizure reduction/effective (>50% reduction)


	Low

Percent reduction in seizures from baseline

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

28. For single arm studies: Were the outcome assessors blinded to the intervention or exposure status of participants?

Seizure freedom


	High

Seizure reduction/effective (>50% reduction)


	High

Percent reduction in seizures from baseline

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

29. For single arm studies: Were interventions/exposures assessed/defined using valid and reliable measures, implemented consistently across all study participants?

Seizure freedom


	Low

Seizure reduction/effective (>50% reduction)


	Low

Percent reduction in seizures from baseline

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

30. For single arm studies: Were outcomes assessed/defined using valid and reliable measures, implemented consistently across all study participants?

Seizure freedom


	Some concerns

Seizure reduction/effective (>50% reduction)


	Some conerns

Percent reduction in seizures from baseline

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

Adverse Event


	Some concerns

31. For single arm studies: Were confounding variables assessed using valid and reliable measures, implemented consistently across all study participants?

Seizure freedom


	Low

Seizure reduction/effective (>50% reduction)


	Low

Percent reduction in seizures from baseline

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

Adverse Event


	Low

32. For single arm studies: Were the potential outcomes prespecified by the researchers? Are all prespecified outcomes reported?

Seizure freedom


	High

Seizure reduction/effective (>50% reduction)


	High

Percent reduction in seizures from baseline

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Adverse Event


	High

Risk of Bias Assessment

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

Results

Categorical

Seizure freedom

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Seizure reduction/effective (>50% reduction)

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Percent reduction in seizures from baseline

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Percentage		95% CI low (OR)
			95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Adverse Event (Anemia)

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Adverse Event (Anorexia)

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Adverse Event (Fatigue)

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Adverse Event (Medication toxicity)

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Adverse Event (Vigabatrin related toxicity)

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Adverse Event (Vision abnormality)

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Adverse Event (Withdrawal due to AE)

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Median 12 months
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin

Adverse Event (Vision abnormality on eye exam)

All Participants
		Descriptive Statistics		Between Arm Comparisons
		Vigabatrin
Before vigabatrin
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
During vigabatrin
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
After vigabatrin
	Total (N analyzed)		Odds Ratio (OR)
	Events		95% CI low (OR)
	Percentage		95% CI high (OR)
			p value
		Within Arm Comparisons		Net Comparisons
		Vigabatrin