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

NCT06901518 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-03-30

No results posted yet for this study

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

Conditions

  • Post-Traumatic Headache

Interventions

DRUG

Galcanezumab-Gnlm

Subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Charles Argoff, MD · Albany Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2024-06-30
Completion
2024-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06901518 on ClinicalTrials.gov