Post-Traumatic HeadachePhase 4NCT06901518
The Effect of Galcanezumab-gnlm on Post-Traumatic, Migrainous Headaches
A Phase 4 study testing Galcanezumab-Gnlm in people with Post-Traumatic Headache, run by Albany Medical College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- Galcanezumab-Gnlm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Aug 2020to 30 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Open-Label Study to Assess the Effect of Galcanezumab-gnlm in Reducing the Frequency and Severity of Post-Traumatic, Migrainous Headaches
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
Read more
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
Read the detailed description
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.
- Conditions
- Post-Traumatic Headache
- Being tested
- Galcanezumab-Gnlm
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galcanezumab-GnlmDrug
Also called EMGALITY
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Galcanezumab-Gnlm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (4)
Headache frequency and severity
Headache frequency and severity as reported in the headache diary
Measured: 16 weeks
Mean change in headache days per month
Mean change in headache days per month at 8 weeks and 12 weeks compared to baseline
Measured: 8 weeks and 12 weeks
Mean change in HIT-6 score
Mean change in Headache Impact Test (HIT-6) score from baseline
Measured: 16 weeks (study end)
Mean change in average number of days that acute headache medications used per month
Mean change in average number of days that acute headache medications were used per month as reported in the 8, 12, and 16 week appointment, compared to baseline data
Measured: 8, 12, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start10 Aug 2020
- Primary completion30 Jun 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Charles Argoff, Albany Medical College
- Investigators
- Charles Argoff, MD, Principal investigator, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901518
- Sponsor's protocol ID
- 5843
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Open-Label Study to Assess the Effect of Galcanezumab-gnlm in Reducing the Frequency and Severity of Post-Traumatic, Migrainous Headaches
- ClinicalTrials.gov ID
- NCT06901518
- Acronym / sponsor ID
- 5843
- Conditions
- Post-Traumatic Headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment arm | Experimental | Drug: Galcanezumab-GnlmAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 18 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galcanezumab-GnlmAlso: EMGALITYSubcutaneous injection | Drug | Active treatment arm |
Primary outcome
Mean change in number of migraine days per month
Time frame: 16 weeks
To determine the mean change in number of migraine days per month at study end compared to baseline pre-injection 4-week period
4 secondary outcomes
Headache frequency and severity
Time frame: 16 weeks
Mean change in headache days per month
Time frame: 8 weeks and 12 weeks
Mean change in HIT-6 score
Time frame: 16 weeks (study end)
Mean change in average number of days that acute headache medications used per month
Time frame: 8, 12, and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Argoff, MD principal investigator
Albany Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Galcanezumab-Gnlm in people with Post-Traumatic Headache, run by Albany Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in number of migraine days per month (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.