The Effect of Galcanezumab-gnlm on Post-Traumatic, Migrainous Headaches

At study start, participants will review eligibility criteria with the investigator, undergo a physical exam, and review concomitant medications and medical history. Participants will be given a HIT-6 assessment as a baseline score. Participants will then be instructed to complete a headache diary over the next 4 weeks to record frequency and severity of migrainous headaches, changes to their health, and any other associated symptoms they have experienced. Participants will return for their second study visit at week four to review their headache diary results, ensure continued eligibility for the study based on their diary results, and undergo a brief physical exam. If participants are determined to be eligible, they will receive treatment with subcutaneous galcanezumab-gnlm in the clinic. Galcanezumab-gnlm 120mg and 240mg are FDA-approved for the treatment of chronic and episodic migraines. Participants will be observed following the treatment for 15 minutes to assess and record adverse reactions. They will also complete a HIT-6 score. The patient's vital signs will be rechecked following this 15 minute observation period. At the third study visit, week eight, participants will return to clinic to review their headache diary and any changes to their health or medications since the previous study visit. Participants will undergo a brief physical exam and a HIT-6 test and be injected with subcutaneous galcanezumab-gnlm and monitored for 15 minutes. This process will be repeated during the fourth study visit, week twelve, when participants receive their third and final subcutaneous injection of galcanezumab-gnlm. At the fifth and final study visit, week sixteen, a brief physical exam will be completed, headache diaries will be reviewed with the participant, and a final HIT-6 test will be administered, comparing this score to the previous HIT-6 scores.

Data will be collected throughout the study at the time of each visit, week 0 (study start), week 4, week 8, week 12, and week 16 (study end). During these visits, a HIT-6 score will be completed in clinic to determine the impact that post-traumatic, migrainous headaches have on participants' daily lives. Additionally, headache diaries will be completed by study participants between each visit, and these diaries will be reviewed by the investigator at each visit to further clarify the impact that galcanezumab-gnlm has on overall reduction in post-traumatic, migrainous headache frequency and severity. Headache diaries will reflect the new occurrence and increase or decrease in associated symptoms experienced throughout the twenty-eight -day period between each study visit.