Table 4.
Ongoing studies on eptinezumab registered on clinical trials.
| Study design | Status | Planned N | Diagnosis / Age | Primary endpoint | Identifier / Name |
|---|---|---|---|---|---|
| Observational, prospective (3 years) | Recruiting | 500 | HFEM and CM (aged 18–75) | Change in the number of MMDs from baseline to month 3–6–9-12 | NCT05570149 EMBRACE (87) |
| Interventional, randomized, double-blind, parallel-group, placebo-controlled | Recruiting | 570 | Migraine and MOH (aged 18–75) | Change in the number of MMDs from baseline to weeks 1–4 |
NCT05452239 RESOLUTION (35) |
| Interventional, randomized, double-blind, parallel-group, placebo-controlled delayed-start | Completed | 304 | eCH (aged 18–75) | Change from baseline in the number of weekly attacks, averaged over weeks 1–2 |
NCT04688775 ALLEVIATE (36) |
| Interventional, randomized, double-blind, parallel-group, placebo-controlled | Recruiting | 513 | CM (aged 18–75) | Change in the number of MMDs from baseline to weeks 1–12 |
NCT04921384 SUNRISE (37) |
| Interventional, randomized, double-blind, parallel-group, placebo-controlled | Recruiting | 285 | CM (aged 12–17) | Change from baseline in number of MMDs averaged over weeks 1–12 |
NCT04965675 PROSPECT-2 (38) |
| Long-term, open-label (dose-blinded), extension of the PROSPECT-2 and 19357A study | Recruiting | 610 | EM or CM (aged 6–17) | Number of patients with TEAEs from baseline up to week 44 |
NCT05164172 REJOIN (39) |
| Interventional, open-label, fixed-dose, long-term extension of the SUNRISE | Enrolling | 100 | CM (aged 18–75) | Number of participants with AEs from baseline up to week 68 | NCT05064371 (40) |
| Interventional, open-label, fixed-dose multiple administration | Active, not recruiting | 131 | cCH (aged 18–75) | Number of participants with AEs from baseline up to week 56 |
NCT05064397 CHRONICLE (41) |
| Open-label, single-dose, pharmacokinetic | Active, not recruiting | 28 | EM or CM (aged 6–17) | AUC (0-infinity) eptinezumab from dosing to week 20 | NCT04537429 (42) |
AEs, adverse events; AUC, Area under curve; cCH, chronic cluster headache; eCH, episodic Cluster Headache; EM, episodic migraine; MMDs, monthly migraine days; MOH, medication-overuse headache; The ‘-‘symbol indicates that no mention on the name was made on the website.