Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

Study acronym: OASIS(EM)
StatusActive, Not Recruiting
PhasePhase 3
SponsorAmgen
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 130 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 119 → 11 locations
    • Study completion date: Nov 19, 2026 to Nov 17, 2026
  2. Eligibility criteria expanded, about 53 words
    • Secondary endpoints: details revised at 1 of 13 entries
    • Study description revised
  3. Study completion date: Nov 15, 2026 to Nov 19, 2026v128
  4. Study completion date: Nov 23, 2026 to Nov 15, 2026
    • Secondary endpoints revised (13)
    v127
  5. Study completion date: Oct 13, 2026 to Nov 23, 2026v126
Show 45 earlier versionsHide 45 earlier versions
  1. Trial status: Recruiting to Active, Not Recruitingv125 Show 4 more changesShow less
    • Enrollment target: estimated 436 to confirmed 457
    • Study sites: 120 to 119
    • Primary completion date: Dec 19, 2025 to Nov 19, 2025
    • Study completion date: Dec 17, 2026 to Oct 13, 2026
  2. Enrollment target: 456 to 436
    • Secondary endpoints: 5 to 13
    • Study description revised
    v124
  3. Study sites: 119 to 120v123
  4. Study sites: 120 to 119v122
  5. Study sites revised (120)v121
  6. Study sites revised (120)v120
  7. Site details revised at 1 of 120 sitesv119
  8. Site details revised at 1 of 120 sitesv118
  9. Study sites: 119 to 120
    • Primary completion date: Mar 18, 2026 to Dec 19, 2025
    • Study completion date: Feb 10, 2027 to Dec 17, 2026
    v117
  10. Site details revised at 1 of 119 sitesv116
  11. Study sites: 117 to 119v115
  12. Site details revised at 1 of 117 sitesv114
  13. Study completion date: Jun 8, 2027 to Feb 10, 2027
    • Study sites revised (117)
    v113
  14. Site details revised at 4 of 117 sitesv112
  15. Study sites: 116 to 117v111
  16. Study completion date: Jun 8, 2026 to Jun 8, 2027
    • Site details revised at 1 of 116 sites
    v110
  17. Primary completion date: May 6, 2026 to Mar 18, 2026
    • Study completion date: May 5, 2027 to Jun 8, 2026
    • Site details revised at 1 of 116 sites
    v109
  18. Study sites revised (116)v108
  19. Study sites revised (116)v107
  20. Study sites: 115 to 116v106
  21. Study sites: 114 to 115v105
  22. Study sites: 113 to 114v104
  23. Study sites: 112 to 113v103
  24. Primary completion date: Jun 17, 2026 to May 6, 2026
    • Study completion date: Jul 29, 2027 to May 5, 2027
    • Study sites revised (112)
    v102
  25. Study sites revised (112)v101
  26. Site details revised at 1 of 112 sitesv100
  27. Study sites revised (112)v99
  28. Study sites: 111 to 112v98
  29. Study sites revised (111)v97
  30. Site details revised at 2 of 111 sitesv96
  31. Site details revised at 1 of 111 sitesv95
  32. Study sites: 110 to 111v94
  33. Re-verified, no change to tracked fieldsv93
  34. Primary endpoint revisedv92 Show 5 more changesShow less
    • Study sites: 109 to 110
    • Secondary endpoints: 6 to 5
    • Study description expanded, about 7 words
    • Study title revised
    • Eligibility criteria expanded, about 4 words
  35. Study sites: 106 to 109v91
  36. Site details revised at 1 of 106 sitesv90
  37. Study sites: 105 to 106v89
  38. Study sites: 104 to 105v88
  39. Study sites: 102 to 104v87
  40. Study sites: 101 to 102v86
  41. Study sites: 99 to 101
    • Primary completion date: May 6, 2026 to Jun 17, 2026
    • Study completion date: May 5, 2027 to Jul 29, 2027
    v85
  42. Study sites: 98 to 99v84
  43. Site details revised at 1 of 98 sitesv83
  44. Study sites: 96 to 98v82
  45. Study sites: 95 to 96v81
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Amgen
169 trials monitored
See 11 trials at risk
Migraine
483 trials monitored
See 27 trials at risk
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to \<12 years) and adolescents (12 to \<18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).
Trial Details
NCT Number NCT03836040
Lead Sponsor Amgen
Collaborators: Novartis
Conditions
(from sponsor)		 Migraine
Related terms Headache, Migraine Disorders
Enrollment 457 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov