Comparison · NCT03828539-7220683d
Erenumab vs Topiramate: EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24
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. Erenumab vs Topiramate: EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24. Trial comparisons, record NCT03828539-7220683d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03828539-7220683d
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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 | 0.722 | 0.675 | 0.764 | wilson | |
| Risk in group 2 | 0.539 | 0.489 | 0.588 | wilson | |
| Risk difference, group 1 minus group 2 | 0.183 | 0.115 | 0.248 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.34 | 1.2 | 1.5 | log | |
| Odds ratio, group 1 over group 2 | 2.22 | 1.65 | 2.99 | log | |
| Number needed to treat, for one more participant with the outcome on Erenumab than on Topiramate | 5.46 | 4.03 | 8.67 | from the risk difference interval |
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 | Erenumab | 70 mg and 140 mg Erenumab | 280 | 388 | OG000 |
| Group 2 | Topiramate | Topiramate in the highest tolerated dose (50 - 100 mg/day) | 209 | 388 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24
- Description
The HIT-6 is a widely used patient-reported outcome measure that assesses the negative effects of headaches on normal activity. Six items assess the frequency of pain severity, headaches limiting daily activity (household, work, school, and social), wanting to lie down when headache is experienced, feeling too tired to work or do daily activities because of headache, feeling fed up or irritated because of headache, and headaches limiting ability to concentrate or work on daily activities. Each of the 6 questions is responded to using 1 of 5 response categories: never, rarely, sometimes, very often, or always. For each HIT-6 item, 6, 8, 10, 11, or 13 points, respectively, are assigned to the response provided. These points are summed to produce a total HIT-6 score that ranges from 36 to 78. HIT-6 scores are categorized into 4 grades: little or no impact (49 or less), some impact (50 - 55), substantial impact (56 - 59), and severe impact (60 - 78) due to headache.
- Time frame
- Baseline, Week 24
- Population
- Full Analysis Set (FAS)
Source ClinicalTrials.gov
Trial
- Title
- Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
- NCT number
- NCT03828539
- Phases
- PHASE4
- Conditions
- Migraine
- Interventions
- Erenumab, Topiramate, Erenumab matching placebo, Topiramate matching placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2021-08-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03828539?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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