A Multicenter Assessment of ALD403 in Chronic Migraine


About this study

The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic migraineurs.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year
  • During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary
  • Headache eDiary was completed on at least 22 of the 28 days prior to randomization

Exclusion Criteria:

  • Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome) or any pain syndrome that requires regular analgesia
  • Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening.
  • History or diagnosis of complicated migraine (ICHD-III beta version, 2013), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine
  • Unable to differentiate migraine from other headaches
  • Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 6 months prior to screening.
  • Have any clinically significant concurrent medical condition
  • Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)
  • Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Rashmi Halker Singh, M.D.

Closed for enrollment

More information


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Additional contact information

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