Trial · NCT03828539
Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
NCT03828539, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2021-08-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine. Trials, record NCT03828539. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03828539
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
- NCT number
- NCT03828539
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 777 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Migraine
- Interventions
- Erenumab, Topiramate, Erenumab matching placebo, Topiramate matching placebo
- First posted
- 2019-02-04
- Last updated
- 2021-10-11
- Other registries' IDs
- eudract:2018-000943-15
- Results first posted
- 2021-08-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) | 24 Weeks | The primary objective was to demonstrate the tolerability of 70 mg and 140 mg erenumab compared to topiramate in the highest tolerated dose assessed by the rate of patients discontinuing treatment due to AE during the double-blind epoch of the study. |
| Secondary | Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6) | Baseline, Last three months (month 4, 5, and 6) | The secondary objective of this study was to evaluate the effect of erenumab compared to topiramate on the proportion of patients with at least 50% reduction from baseline in MMDs. The Baseline period was defined as the period between Week -4 and the day prior to first dose. This was analyzed by logistic regression over the last 3 months (months 4, 5, and 6) of treatment. All the subjects' data collected regarding 50% response in MMD was used in the analysis regardless of whether subjects discontinue study treatment or not. Subjects with missing response information on this endpoint were imputed as non-response (non-responder imputation). |
| Other | EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24 | Baseline, Week 24 | 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. |
| Other | EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Increase in the Medical Outcome Short Form Health Survey Version 2 (SF-36) From Baseline to Week 24 | Baseline, Week 24 | The SF-36 is a widely used and extensively studied instrument to measure health-related quality of life (HRQoL) among healthy subjects and patients with acute and chronic conditions. It consists of eight subscales that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The SF-36 has proven useful in monitoring general and specific populations, comparing the relative burden of different disease, differentiating the health benefits produced by different treatments, and in screening individual patients. The purpose of the SF-36 in this study was to assess the HRQoL of patients. Given the nature of this disease and the 4-weekly assessment, the SF-36 version 2, with a 4-week recall period, was used in this study. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) | 24 Weeks | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6) | Baseline, Last three months (month 4, 5, and 6) | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24 | Baseline, Week 24 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Increase in the Medical Outcome Short Form Health Survey Version 2 (SF-36) From Baseline to Week 24 | Baseline, Week 24 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) | Erenumab | 41 | Participants | ||
| Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) | Topiramate | 151 | Participants | ||
| Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6) | Erenumab | 215 | Participants | ||
| Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6) | Topiramate | 121 | Participants | ||
| EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24 | Erenumab | 280 | Participants | ||
| EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24 | Topiramate | 209 | Participants | ||
| EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Increase in the Medical Outcome Short Form Health Survey Version 2 (SF-36) From Baseline to Week 24 | Erenumab | Physical Component Summary (PCS) | 185 | Participants | |
| EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Increase in the Medical Outcome Short Form Health Survey Version 2 (SF-36) From Baseline to Week 24 | Topiramate | Physical Component Summary (PCS) | 145 | Participants | |
| EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Increase in the Medical Outcome Short Form Health Survey Version 2 (SF-36) From Baseline to Week 24 | Erenumab | Mental Component Summary (MCS) | 98 | Participants | |
| EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Increase in the Medical Outcome Short Form Health Survey Version 2 (SF-36) From Baseline to Week 24 | Topiramate | Mental Component Summary (MCS) | 65 | Participants |
Source ClinicalTrials.gov
Participant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Erenumab | 389 | |
| Overall Study | STARTED | Topiramate | 388 | |
| Overall Study | Full Analysis Set (FAS) | Erenumab | 388 | |
| Overall Study | Full Analysis Set (FAS) | Topiramate | 388 | |
| Overall Study | Safety Analysis Set (SAF) | Erenumab | 388 | |
| Overall Study | Safety Analysis Set (SAF) | Topiramate | 388 | |
| Overall Study | COMPLETED | Erenumab | 373 | |
| Overall Study | COMPLETED | Topiramate | 366 | |
| Overall Study | NOT COMPLETED | Erenumab | 16 | |
| Overall Study | NOT COMPLETED | Topiramate | 22 |
Source ClinicalTrials.gov
Adverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Erenumab | 20 | 388 | |
| other | Vertigo | Ear and labyrinth disorders | Topiramate | 24 | 388 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Erenumab | 22 | 388 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Topiramate | 23 | 388 | |
| other | Constipation | Gastrointestinal disorders | Erenumab | 48 | 388 | |
| other | Constipation | Gastrointestinal disorders | Topiramate | 12 | 388 | |
| other | Diarrhoea | Gastrointestinal disorders | Erenumab | 20 | 388 | |
| other | Diarrhoea | Gastrointestinal disorders | Topiramate | 29 | 388 | |
| other | Nausea | Gastrointestinal disorders | Erenumab | 36 | 388 | |
| other | Nausea | Gastrointestinal disorders | Topiramate | 71 | 388 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Erenumab | 0 | 388 |
| Total, all-cause mortality | Topiramate | 0 | 388 |
| Total, other adverse events | Erenumab | 253 | 388 |
| Total, other adverse events | Topiramate | 331 | 388 |
| Total, serious adverse events | Erenumab | 10 | 388 |
| Total, serious adverse events | Topiramate | 19 | 388 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 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 |
| Erenumab vs Topiramate: Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) | Trial comparisons |
| Erenumab vs Topiramate: Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6) | Trial comparisons |
| Erenumab vs Topiramate: deaths from any cause | Trial comparisons |
| Erenumab vs Topiramate: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03828539
GET https://conductscience.org/api/trials/v1/NCT03828539/events?page=2