Summary

for people ages 18-70 (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of fremanezumab in adult patients aged 18 to 70 years, inclusive, for the prevention of PPTH. Patients will provide written informed consent and during study visits they will use an electronic diary application daily, to report their headache status and other health information. Efficacy and immunogenicity status will be captured periodically and at study termination. The safety will be evaluated through adverse event report, concomitant medication inquiries, ECGs, clinical laboratory tests and physical examination. Additional evaluations will include pharmacokinetic, biomarker, and pharmacogenomics.

Official Title

A Phase 2, Multicenter, Randomized, Proof-of-Concept, Double Blind, Placebo Controlled, Parallel Group Study Comparing the Efficacy and Safety of 1 Subcutaneous Dose Regimen of Fremanezumab Versus Placebo for the Prevention of Persistent Posttraumatic Headache (PPTH)

Keywords

Post-Traumatic Headache persistent posttraumatic headache (PPTH) Headache Fremanezumab

Eligibility

You can join if…

Open to people ages 18-70

  • 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 PPTH
  • 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

You CAN'T join if...

  • 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.
  • The patient has PPTH attributed to craniotomy.
  • The patient has whiplash with only neck pain and no persistent headache >3 months after whiplash.
  • The patient is using analgesic medications containing opioids (including codeine) or a barbiturate on average more than 15 days per month.
  • The patient is currently using or has prior exposure to any calcitonin gene-related peptide (CGRP) antibody, any antibody to the CGRP receptor.
  • 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

Locations

  • Teva Investigational Site 14060 accepting new patients
    San Diego California 92161 United States
  • Teva Investigational Site 14052 accepting new patients
    Long Beach California 90806 United States
  • Teva Investigational Site 14053 not yet accepting patients
    Los Angeles California 90073 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Teva Branded Pharmaceutical Products, R&D Inc.
ID
NCT03347188
Phase
Phase 2
Study Type
Interventional
Last Updated
May 7, 2018