Baseline characteristics reflected a population with substantial burden of disease1:
- On average, patients experienced 8.4 migraine headache days per month*
- 54% of patients has ≥8 migraine headache days per month
~100% of patients were compliant with Nurtec EOD dosing1
Over the 3-month double-blind period, treatment compliance was 100.8% in the Nurtec ODT group and 99.8% in the galcanezumab group1†
Nurtec ODT is the only oral CGRP antagonist with results
from a head-to-head trial vs a CGRP-targeting mAb1
from a head-to-head trial vs a CGRP-targeting mAb1
Nurtec ODT is the only oral CGRP antagonist with results from a head-to-head trial vs a CGRP-targeting mAb1
| Most Common TEAEs in CHALLENGE-MIG1 | Nurtec ODT‡
(n=293)
|
Galcanezumab§
(n=287)
|
|---|---|---|
| Any TEAE | 60 (20.5%) | 60 (20.9%) |
| TEAEs reported in ≥1% of patients in either arm | ||
| COVID-19 | 5 (1.7%) | 12 (4.2%) |
| Nausea | 4 (1.4%) | 3 (1%) |
| Fatigue | 4 (1.4%) | 2 (0.7%) |
| Injection‑site pain | 4 (1.4%) | 2 (0.7%) |
| Nasopharyngitis | 5 (1.7%) | 1 (0.3%) |
| Influenza | 2 (0.7%) | 3 (1%) |
| Anemia | 1 (0.3%) | 3 (1%) |
| Migraine | 4 (1.4%) | 0 (0%) |
| Sinusitis | 3 (1%) | 1 (0.3%) |
| Constipation | 0 (0%) | 3 (1%) |
No clinically meaningful differences in vital signs or laboratory parameters were observed between arms1
- 2 patients discontinued galcanezumab due to depressed level of consciousness or injection-site pain
- 4 patients discontinued Nurtec ODT due to fatigue, migraine, pulmonary embolism, or somnolence
1 serious AE was reported1
- One patient taking Nurtec ODT who had an undisclosed baseline history of pulmonary embolism experienced a pulmonary embolism while on treatment
- The patient recovered from the event and discontinued the study
- The investigator considered the event to be treatment related
‡Participants received Nurtec ODT 75 mg and a subcutaneous placebo injection.1
§Participants received galcanezumab 120 mg and placebo.1
CHALLENGE-MIG was the first head-to-head trial to compare 2 anti–CGRP therapies for preventive treatment of migraine1,2
The efficacy and safety of galcanezumab 120 mg SC monthly and Nurtec ODT 75 mg EOD were investigated in a randomized, double-blind, double-dummy, parallel-group trial enrolling 580 total patients. The primary aim was to determine whether galcanezumab was superior to Nurtec as preventive treatment for episodic migraine.1
Primary endpoint¹
- Proportion of patients with ≥50% reduction from baseline in monthly migraine headache days||
Inclusion criteria1
- Eligible participants were men and women aged 18 to 75 years with a ≥1-year history of episodic migraine with or without aura, as defined by the International Classification of Headache Disorders, 3rd edition (ICHD-3), and an initial presentation of migraine before age 50 years. During the baseline phase, participants had to have 4–14 migraine headache days per month, at least 2 migraine attacks per month, and 80% compliance with using the eDiary. Women of childbearing potential had to agree to use birth control during the study and for 5 months following the last dose of study drug.
Exclusion criteria1,3
- Individuals were excluded if they had a history of ≥15 headache days per month, had a diagnosis of chronic migraine per ICHD-3, or used preventive migraine therapy (other than study drug) within 5 days of the baseline visit and during the study. Individuals were also excluded if they had prior exposure to or currently used a CGRP antagonist (mAb or gepant); known hypersensitivity to rimegepant or galcanezumab; concomitantly used strong or moderate CYP3A4 inhibitors, strong or moderate CYP3A inducers, or inhibitors of P-gp and BCRP; acute CV events and/or serious CV risk based on ECG at screening or a history of MI, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within 6 months before screening; or hepatic disease based on liver tests. Pregnant and nursing women were also excluded from the study.
||Defined as calendar day which a migraine headache or probable migraine headache occurred.1
Patient Profiles