A Pilot, Open-Label Study to Assess the Effect of Galcanezumab-gnlm in Reducing the Frequency and Severity of Post-Traumatic, Migrainous Headaches
Abstract
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
Conditions: Post-Traumatic Headache.
Primary outcome: Mean change in number of migraine days per month.
Enrollment: 25 participants.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 25 participants or records.
Read the paper
Related studies
- Calcium Ions in the Physiology and Pathology of the Central Nervous System
- AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare
- In silico functional, structural and pathogenicity analysis of missense single nucleotide polymorphisms in human MCM6 gene
- In Silico drug repurposing pipeline using deep learning and structure based approaches in epilepsy
- Targeting serotonin receptors with phytochemicals – an in-silico study
- In silico exploration of anti-prostate cancer compounds from differential expressed genes
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.