Comparison · NCT03689114-87e8f0dd
Low Dose vs Standard Dose: Drug-related Adverse Events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Low Dose vs Standard Dose: Drug-related Adverse Events. Trial comparisons, record NCT03689114-87e8f0dd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03689114-87e8f0dd
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.103 | 0.0358 | 0.264 | wilson | |
| Risk in group 2 | 0.103 | 0.0358 | 0.264 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.174 | 0.174 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.22 | 4.55 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.184 | 5.42 | log | |
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Low Dose | Dosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.~Low dose carbamazepine: Carbamazepine, 300 mg/die~Low dose levetiracetam: Levetiracetam 500 mg/die~Low dose valproate: Valproate 300 mg/die~Low dose zonisamide: Zonisamide 150 mg/die~Low dose oxcarbazepine: Oxcarbazepine 600 mg/die~Low dose topiramate: Topiramate 100 mg/die~Low dose lamotrigine: Lamotrigine 100 mg/die~Low dose gabapentin: Gabapentin 450 mg/die | 3 | 29 | OG000 |
| Group 2 | Standard Dose | Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators.~Standard dose carbamazepine: Carbamazepine 600 mg/die~Standard dose levetiracetam: Levetiracetam 1000 mg/die~Standard dose valproate: Valproate 600 mg/die~Standard dose zonisamide: Zonisamide 300 mg/die~Standard dose oxcarbazepine: Oxcarbazepine 1200 mg/die~Standard dose topiramate: Topiramate 200 mg/die~Standard dose lamotrigine: Lamotrigine 200 mg/die~Standard dose gabapentin: Gabapentin 900 mg/die | 3 | 29 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Drug-related Adverse Events
- Description
- the proportion of patients experiencing a treatment failure motivated by intolerable drug-related adverse events during the follow-up;
- Time frame
- 12 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)
- NCT number
- NCT03689114
- Phases
- PHASE4
- Conditions
- Epilepsies, Partial
- Interventions
Low dose carbamazepine, Standard dose carbamazepine, Low dose levetiracetam, Standard dose levetiracetam, Low dose valproate, Standard dose valproate, Low dose zonisamide, Standard dose zonisamide, Low dose oxcarbazepine, Standard dose oxcarbazepine, Low dose topiramate, Standard dose topiramate, Low dose lamotrigine, Standard dose lamotrigine, Low dose gabapentin, Standard dose gabapentin
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Results first posted
- 2025-07-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03689114?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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