The Effect of Galcanezumab-gnlm on Post-Traumatic, Migrainous Headaches
Status:
COMPLETED
Trial end date:
2024-11-30
Target enrollment:
Participant gender:
Summary
The goal of this pilot, open-label clinical trial is to determine whether the addition of galcanezumab-gnlm to stable conventional headache treatment will reduce the number of monthly migraine days in participants who have experienced a traumatic brain injury and since developed post-traumatic, migrainous headaches. The main questions it aims to answer are:
* if galcanezumab-gnlm is effective in reducing the frequency and severity of post-traumatic headaches with migraine features in study participants
* if galcanezumab-gnlm reduces the impact of migraine on the daily life of the study participants
Participants will complete five clinic visits over the study. Study participants will
* complete a baseline visit including a HIT-6 Headache Impact Test score
* complete a headache diary for 4 weeks to record the frequency and severity of migrainous headaches and other information
* if determined to be eligible for the trial, undergo a brief physical exam and receive treatment with galcanezumab-gnlm, with a loading dose of 240mg delivered subcutaneously
* receive two subcutaneous treatments with galcanezumab-gnlm (120mg) 4 weeks apart
* complete a final study visit with a brief physical exam and HIT-6 Headache Impact Test score