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NCT06901518

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

Completed Phase 4 Last updated 30 March 2025
What this trial tests

Phase 4 trial testing Galcanezumab-Gnlm in Post-Traumatic Headache in 25 participants. Completed in 30 November 2024.

Timeline
10 August 2020
Primary endpoint
30 June 2024
30 November 2024

Quick facts

Lead sponsorAlbany Medical College
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment25
Start date10 August 2020
Primary completion30 June 2024
Estimated completion30 November 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Albany Medical College

Who can join

18 and older, any sex, with Post-Traumatic Headache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Post-Traumatic Headache

Currently open trials in the same condition.

Other Albany Medical College trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06901518.

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