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NCT06901518
The Effect of Galcanezumab-gnlm on Post-Traumatic, Migrainous Headaches
Phase 4 trial testing Galcanezumab-Gnlm in Post-Traumatic Headache in 25 participants. Completed in 30 November 2024.
30 June 2024
Quick facts
| Lead sponsor | Albany Medical College |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 10 August 2020 |
| Primary completion | 30 June 2024 |
| Estimated completion | 30 November 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Galcanezumab-Gnlm — full drug profile →
Conditions studied
- Post-Traumatic Headache — all drugs for Post-Traumatic Headache →
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:
- PubMed search for NCT06901518
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Related trials
Other recruiting trials for Post-Traumatic Headache
Currently open trials in the same condition.
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- NCT05857761 — GAIN Symptoms: Post-traumatic Headache · NA · active not recruiting
- NCT06015451 — Exercise in Postconcussion Symptoms and Posttraumatic Headache · NA · recruiting
Other Albany Medical College trials
Trials by the same sponsor.
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- NCT06668766 — Single Lumen Midline Catheter vs Long Peripheral Intravenous Cather for Difficult Intravenous Access in the ED · NA · recruiting
- NCT06677541 — Vibrator Use to Improve Sexual and Pelvic Floor Function Among Urogynecology Patients · NA · recruiting
- NCT02703610 — Randomized Trial of Two Analgesics in Elderly ED Patients · Phase 4 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06901518 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Albany Medical College
- Last refreshed: 30 March 2025
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing