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Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
Phase 4 trial testing Erenumab in Migraine in 777 participants. Completed in 29 July 2020.
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 777 |
| Start date | 22 February 2019 |
| Primary completion | 29 July 2020 |
| Estimated completion | 29 July 2020 |
| Sites | 79 locations across Germany |
Novartis Pharmaceuticals — full company profile →
Adults 18 to 65, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Erenumab | 41 | |
| Topiramate | 151 |
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 imput
| Group | Value | 95% CI |
|---|---|---|
| Erenumab | 215 | |
| Topiramate | 121 |
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,
| Group | Value | 95% CI |
|---|---|---|
| Erenumab | 280 | |
| Topiramate | 209 |
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 relati
| Group | Value | 95% CI |
|---|---|---|
| Erenumab | 185 | |
| Topiramate | 145 |
| Group | Value | 95% CI |
|---|---|---|
| Erenumab | 98 | |
| Topiramate | 65 |
Time frame: Adverse events were collected from first dose of study treatment until 8 weeks after the last Investigational Medicinal product (IMP) injection, assessed up to approximately 33 weeks (treatment duration ranged from 4.0 to 25.1 weeks).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Erenumab | Topiramate |
|---|---|---|---|
| Angle closure glaucoma | Eye disorders | — | — |
| Retinal detachment | Eye disorders | — | — |
| Rhegmatogenous retinal detachment | Eye disorders | — | — |
| Gastritis | Gastrointestinal disorders | — | — |
| Irritable bowel syndrome | Gastrointestinal disorders | — | — |
| Mechanical ileus | Gastrointestinal disorders | — | — |
| Obstructive defaecation | Gastrointestinal disorders | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — |
| Anaphylactic shock | Immune system disorders | — | — |
| Appendicitis | Infections and infestations | — | — |
| Bacteriuria | Infections and infestations | — | — |
| Gastroenteritis | Infections and infestations | — | — |
| Gastrointestinal infection | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Papilloma viral infection | Infections and infestations | — | — |
| Parasitic gastroenteritis | Infections and infestations | — | — |
| Pyelonephritis | Infections and infestations | — | — |
| Ankle fracture | Injury, poisoning and procedural complications | — | — |
| Concussion | Injury, poisoning and procedural complications | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Ligament rupture | Injury, poisoning and procedural complications | — | — |
| Limb injury | Injury, poisoning and procedural complications | — | — |
| Skin laceration | Injury, poisoning and procedural complications | — | — |
| Reaction | System | Erenumab | Topiramate |
|---|---|---|---|
| Paraesthesia | Nervous system disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Disturbance in attention | Nervous system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Taste disorder | Nervous system disorders | — | — |
| Vertigo | Ear and labyrinth disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Weight decreased | Investigations | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Sleep disorder | Psychiatric disorders | — | — |
Most-reported serious reactions: Angle closure glaucoma, Retinal detachment, Rhegmatogenous retinal detachment, Gastritis, Irritable bowel syndrome, Mechanical ileus, Obstructive defaecation, Cholelithiasis.
Data from ClinicalTrials.gov NCT03828539 adverse events section.
This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could have failed up to three prophylactic treatments out of: propranolol/metoprolol, amitriptyline, flunarizine. Patients were stratified into groups according to their number of migraine days during the baseline period.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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