Status:
COMPLETED
The Effect of Galcanezumab-gnlm on Post-Traumatic, Migrainous Headaches
Lead Sponsor:
Albany Medical College
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Post-Traumatic Headache
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06901518
Start Date
August 10 2020
End Date
November 30 2024
Last Update
March 30 2025
Active Locations (1)
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1
Albany Medical Center
Albany, New York, United States, 12208