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

NCT06901518 | Completed Phase 4 FDA Drug

• 1 other identifier: 5843
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean change in number of migraine days per month

  To determine the mean change in number of migraine days per month at study end compared to baseline pre-injection 4-week period

  16 weeks

Secondary Outcomes (4)

• Headache frequency and severity

  16 weeks

• Mean change in headache days per month

  8 weeks and 12 weeks

• Mean change in HIT-6 score

  16 weeks (study end)

• Mean change in average number of days that acute headache medications used per month

  8, 12, and 16 weeks

Study Arms (1)

Active treatment arm

EXPERIMENTAL

All participants are in the active treatment arm, which consists of subcutaneous injections of galcanezumab-gnlm. The first dose is the FDA-approved loading dose of 240mg (120mg injections into two separate subcutaneous sites). The second and third doses consist of a single 120mg subcutaneous injection of galcanezumab-gnlm.

Drug: Galcanezumab-Gnlm

Interventions

Galcanezumab-Gnlm DRUG

Subcutaneous injection

Also known as: EMGALITY

Active treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented history of traumatic brain injury (TBI); acceptable TBI diagnoses could include concussion, SDH, ICH, and/or SAH diagnosed using ICD-10 coding by a medical professional.
• Frequent post-traumatic headaches with migraine features as defined by the International Classification of Headache Disorders, 3rd Edition (ICHD-3), and this must be documented using ICD-10 coding by a medical professional.
• Able to consent and participate in this research study.
• years of age or older.
• Trial participants may also be using a stable dose of one migraine preventative medication recognized by AHS/AAN as level A or B, for at least 4 months prior to the start of the study screening and start date. Participants should remain on this stable dose throughout the study.
• Participants who are being treated with OnabotulinumtoxinA and still meet criteria for migraine preventative treatment will be allowed to enroll.
• Participants may have focal neurologic deficits as a result of suffering a TBI.
• After review of the headache diary completed during the baseline period, the participant can be classified by the investigator as experiencing either chronic or episodic migraine; Chronic migraine is characterized by the participant having 15 or more headache days, at least 8 of which classify as a migraine. Episodic migraine is characterized by the participant having fewer than 15 headache days per month, and at least 4 of these headache days would classify as migraine.

You may not qualify if:

• Under 18 years of age
• Participant has a history of migraine headaches, diagnosed via ICD-10 coding and as defined by ICHD-3 criteria, occurring prior to the traumatic brain injury.
• Participant is not experiencing headaches with migrainous features as defined by the ICHD-3 criteria.
• Participant is pregnant or lactating or planning on becoming pregnant within the next six months.
• Participant is unable to give consent to participate.
• Participant began using unconventional interventions or devices aimed at reducing migraines, like nerve blocks and transcranial magnetic stimulation, within the 2 months prior to study screening.
• Participant is using opioid or barbiturate therapies on 5 or more days during pre-intervention period.

Sponsors & Collaborators

• Albany Medical College: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

erenumab

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Charles Argoff, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: March 30, 2025
• Study Start: August 10, 2020
• Primary Completion: June 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)