Phase 3
N=900
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients
Episodic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03333109 ↗Enrolled (actual)
900
Serious AEs
1.7%
Results posted
Mar 2021
Primary outcome: Primary: Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP) — -4.20; -4.79; -3.10 Migraine days/month — p=0.002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Erenumab (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP) |
-4.20; -4.79; -3.10 | 0.002 sig |
| SECONDARY Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3 |
55.3; 63.9; 44.8 | 0.007 sig |
| SECONDARY Change From Baseline in Acute Migraine-specific Medication Treatment Days at Month 3 |
-1.84; -2.39; -0.49 | <0.001 sig |
| SECONDARY Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3 |
-8.39; -9.34; -6.62 | 0.004 sig |
Summary
This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine
Eligibility Criteria
Key inclusion criteria
- Documented history of migraine in the 12 months prior to screening
- 4-14 days per month of migraine symptoms
- >=80% diary compliance during the Baseline period
Key exclusion criteria
- >50 years old at migraine onset
- Pregnant or nursing
- History of cluster or hemiplegic headache
- Evidence of seizure or major psychiatric disorder
- Score of 19 or higher on the BDI
- Active chronic pain syndrome
- Cardiac or hepatic disease
Data sourced from ClinicalTrials.gov (NCT03333109). 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.