Phase 3
Completed N=261
A Controlled Trial of Erenumab in Migraine Prevention
Source: ClinicalTrials.gov NCT03812224 ↗Enrolled (actual)
261
Serious AEs
2.1%
Results posted
Mar 2021
Primary outcomePrimary: Change From Baseline in Mean Monthly Migraine Days (MMD) Over Months 4, 5, and 6 of the Double-blind Treatment Period — -1.98; -3.60 migraine days / month — p=<0.001
◆ Published Evidence
Established
22citations · ~4 / year
Efficacy and safety of erenumab in Japanese migraine patients with prior preventive treatment failure or concomitant preventive treatment: subgroup analyses of a phase 3, randomized trial.
Summary
The purpose of this study was to assess the efficacy and safety of erenumab for prevention of migraine in Japanese adults with episodic migraine (EM) and chronic migraine (CM).
Linked Publications (4)
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Efficacy and safety of erenumab in Japanese migraine patients with prior preventive treatment failure or concomitant preventive treatment: subgroup analyses of a phase 3, randomized trial.
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Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions.
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Long-term efficacy and safety of erenumab in Japanese patients with episodic and chronic migraine: results from a 28-week open-label treatment period of a randomised trial.
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Experiences of Migraine and Erenumab Treatment in Japan: Qualitative Interviews with Clinical Trial Participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Monthly Migraine Days (MMD) Over Months 4, 5, and 6 of the Double-blind Treatment Period |
-1.98; -3.60 | <0.001 sig |
| SECONDARY Percentage of Participants With at Least a 50% Reduction From Baseline in Mean Monthly Migraine Days Over Months 4, 5, and 6 of the DBTP |
16.8; 31.5 | 0.005 sig |
| SECONDARY Change From Baseline in Mean Monthly Acute Migraine-specific Medication Treatment Days Over Months 4, 5, and 6 of the DBTP |
-1.10; -2.57 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Subject has provided informed consent/assent prior to initiation of any study specific activities/procedures.
- Japanese subjects greater than or equal to 20 to less than or equal to 65 years of age upon entry into screening.
- History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report
- Migraine frequency: Chronic Migraine (CM) or Episodic Migraine (EM) over the 3 months before screening based on the following criteria:
- CM is defined as greater than or equal to 15 headache days per month of which greater than or equal to 8 headache days on average across the 3 months meet criteria as migraine days
- EM is defined as less than 15 headache days per month of which at least 4 or more headache days on average across the 3 months meet criteria as migraine days
Exclusion Criteria
- Subjects greater than 50 years of age at migraine onset.
- History of cluster headache or hemiplegic migraine headache.
- Unable to differentiate migraine from other headaches.
- Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period.
- Malignancy, except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years.
Other exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT03812224) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.