Health Condition 1: null- Episodic Migraine
Conditions
Interventions
Intervention1: AMG 334 70 mg/1 mL: AMG 334 70 mg/1 mL pre-filled syringe
Control Intervention1: Matching placebo: Matching placebo in 1 mL pre-filled syringe, identical in appearance
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults =18 to =65 years of age upon entry into screening 2.Documented history of migraine (with or without aura) for =12 months prior to screening according to the ICHD-3 3. 4-14 days per month of migraine symptoms (based on ICHD-3 criteria) on average across the 3 months prior to screening 4. 5.During baseline: Confirmed migraine frequency of 4-14 migraine days 6. During baseline: =80% compliance with the headache diary 7. Adults =18 to =65 years of age 8.Documented history of migraine (with or without aura) for =12 months prior to screening according to the ICHD-3
Exclusion criteria
Exclusion criteria: Key exclusion criteria: 1. >50 years old at migraine onset 2.Pregnant or nursing 3.History of cluster or hemiplegic headache 4.Evidence of seizure or major psychiatric disorder 5.Score of 19 or higher on the BDI 6.Active chronic pain syndrome 7.Cardiac or hepatic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in monthly migraine days at the last month (Month 3) of the double-blind treatment period (DBTP)Timepoint: 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Achievement of at least a 50% reduction from baseline in monthly migraine days at Month 3. 2. •Change from Baseline in acute migraine-specific medication treatment days at Month 3. 3. •Change from Baseline in headache impact scores as measured by the HIT-6 at Month 3.Timepoint: 1. Time frame-3 months 2. Time frame-3 months 3. Time frame-3 months | — |
Countries
India, Taiwan
Contacts
Public ContactMurugananthan K
Novartis Healthcare Pvt. Ltd
Outcome results
None listed