Last updated on December 2019

A Study to Test if Fremanezumab Reduces Headache in Patients With Posttraumatic Headache (PTH)


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Post-Traumatic Headache
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

Inclusion Criteria:

  • The patient has a body weight is greater than 99 lbs.
  • Traumatic injury to the head has occurred, defined as a structural or functional injury resulting from the action of external forces.
  • The patient has a diagnosis of PTH
  • The patient is not using preventive medications for headache
  • Women of childbearing potential whose male partners are potentially fertile (ie, no vasectomy) must use highly effective birth control methods for the duration of the study. Men must be sterile or, if they are potentially fertile or reproductively competent (ie, not surgically or congenitally sterile) and their female partners are of childbearing potential, must use, together with their female partners, acceptable birth control methods for the duration of the study.

NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

  • The patient has a previous history of brain imaging showing evidence of intracerebral hemorrhage, subdural or epidural hematomas, or subarachnoid hemorrhage as a consequence of the traumatic head injury. Brain images with structurally insignificant changes, as discussed and approved by the sponsor, will be reviewed by the sponsor on a case-by-case basis.
  • The patient has PTH attributed to craniotomy.
  • The patient has whiplash and subsequent headache but no history of head injury or concussion.
  • The patient is using analgesic medications containing opioids (including codeine) or a barbiturate on average more than 15 days per month.
  • The patient has had exposure to a mAb targeting the CGRP pathway (erenumab,eptinezumab, galcanezumab, and fremanezumab) during the 6 months prior to the day of the screening visit.
  • The patient has received onabotulinmumtoxinA (eg, Botox, Dysport) application in the head or neck during the previous 3 months before screening.
  • The patient has been implanted with any devices for headache prophylaxis during the previous 3 months before screening.
  • The patient has been treated with a nerve block for head and/or neck during the previous 3 months before screening.
  • The patient is a pregnant or lactating woman or plans to become pregnant during the study.

NOTE- Additional criteria apply, please contact the investigator for more information

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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