Phase 3
Completed N=246
A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
Source: ClinicalTrials.gov NCT03096834 ↗Enrolled (actual)
246
Serious AEs
7.7%
Results posted
Feb 2022
Primary outcomePrimary: Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) — 30.3; 13.7 Percentage of participants — p=0.002
◆ Published Evidence
Established
50citations · ~10 / year
Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study.
Summary
The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.
Linked Publications (5)
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Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study.
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Two-year efficacy and safety of erenumab in participants with episodic migraine and 2-4 prior preventive treatment failures: results from the LIBERTY study.
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Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study.
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Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials.
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Efficacy and Safety of Erenumab in Participants With Episodic Migraine in Whom 2-4 Prior Preventive Treatments Had Failed: LIBERTY 3-Year Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) |
30.3; 13.7 | 0.002 sig |
| SECONDARY Change From Baseline in Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) |
-1.75; -0.16 | 0.004 sig |
| SECONDARY Change From Baseline in Physical Impairment and Everyday Activities as Measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3 |
-1.85; 1.61; -3.36; 0.55 | 0.003 sig |
| SECONDARY Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3 |
-1.25; 0.46 | <0.001 sig |
| SECONDARY Percentage of Participants With a 75% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) |
11.8; 4.0 | 0.025 sig |
| SECONDARY Percentage of Participants With a 100% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment) |
5.9; 0 | — |
| SECONDARY Number of Participants Who Developed Anti-AMG334 Antibodies |
— | — |
Eligibility Criteria
Inclusion Criteria
- Documented history of migraine in the 12 months prior to screen
- 4-14 days per month of migraine symptoms
- >=80% diary compliance during the Baseline period
- Failure of previous migraine prophylactic treatments
Exclusion Criteria
- >50 years old at migraine onset
- Pregnant or nursing
- History of cluster or hemiplegic headache
- Evidence of seizure or psychiatric disorder
- Score of over 19 on Beck Depression Inventory-2
- Active chronic pain syndrome
- Cardiac or hepatic disease
Data sourced from ClinicalTrials.gov (NCT03096834) 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.