Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

• Status: Completed
• Trial end date: 2019-11-12
• Target enrollment: 0
• Participant gender: All

Summary

A study to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days in participants with episodic migraine.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Erenumab

Criteria

Inclusion Criteria:

• History of migraine for more than12 months prior to screening

• Migraine frequency: ≥ 4 and ≤ 14 migraine days per month in each of the 3 months prior to screening and during baseline phase

• Headache frequency: < 15 headache days per month (with > 50% of the headache days being migraine days) in each of the 3 months prior to screening and during baseline phase

• Demonstrated at least 80% compliance with the eDiary during baseline phase

Exclusion Criteria:

• Older than 50 years of age at migraine onset

• History of cluster headache or basilar or hemiplegic migraine headache

• Unable to differentiate migraine from other headaches

• No therapeutic response with > 2 of the following eight medication categories for prophylactic treatment of migraine after an adequate therapeutic trial. Medication categories are:

• Category 1: Divalproex sodium, sodium valproate

• Category 2: Topiramate

• Category 3: Beta blockers (for example: atenolol, bisoprolol, metoprolol, nadolol, nebivolol, pindolol, propranolol, timolol)

• Category 4: Tricyclic antidepressants (for example: amitriptyline, nortriptyline, protriptyline)

• Category 5: Venlafaxine, desvenlafaxine, duloxetine, milnacipran

• Category 6: Flunarizine, verapamil

• Category 7: Lisinopril, candesartan

• Category 8: Butterbur, feverfew, magnesium (≥ 600 mg/day), riboflavin (≥ 100 mg/day)

• Overuse of acute migraine medications in any month during the 3 months prior to screening or during screening