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

Completed · Phase 2 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT01952574

Run by

Amgen

People needed

483

Starts

2013-08-06

Expected to finish

2019-11-12

Last updated by the study team

2022-10-12

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Long Beach, California, United States
• Research Site — National City, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — San Francisco, California, United States
• Research Site — Santa Monica, California, United States
• Research Site — Sherman Oaks, California, United States
• Research Site — Spring Valley, California, United States
• Research Site — Danbury, Connecticut, United States
• Research Site — Fairfield, Connecticut, United States
• Research Site — Stamford, Connecticut, United States
• Research Site — Bradenton, Florida, United States
• Research Site — Melbourne, Florida, United States
• Research Site — Palm Beach Gardens, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Decatur, Georgia, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Lexington, Kentucky, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Watertown, Massachusetts, United States
• Research Site — Worcester, Massachusetts, United States
• Research Site — Ann Arbor, Michigan, United States
• Research Site — Kalamazoo, Michigan, United States
• Research Site — Southfield, Michigan, United States
• Research Site — Plymouth, Minnesota, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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