Phase 3 Migraine Trial, Recruiting NCT05598723 Sponsor: Naval Medical Center Camp Lejeune Condition: Migraine
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Phase 3 Migraine Trial, Recruiting

NCT05598723
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged between 18 and 89 years old
  • People who experience 15 or more headache days per month, where each headache lasts 4 hours or longer
  • People who are eligible for healthcare through the Department of Defense (DoD) or TriCare
  • People who have already tried two different types of migraine medications that either did not work, could not be taken due to medical reasons, or caused intolerable side effects
  • People who are able to give informed consent and can read and write in English
  • People who are able to read, understand, and fill out the study assessments and headache diary
  • Women who can provide a negative urine pregnancy test at the time of joining

Who may not be able to join:

  • People who are currently pregnant, breastfeeding, or planning to become pregnant during the trial
  • People who have a known allergy to botulinum toxin or any of its ingredients
  • People who have been diagnosed with myasthenia gravis, ALS (Lou Gehrig's disease), Eaton Lambert syndrome, mitochondrial disease, fibromyalgia, jaw joint disorders (TMJ), or any other condition that significantly affects nerve or muscle function
  • People who have uncontrolled epilepsy, defined as having more than one generalised seizure per month in the three months before starting the trial
  • People who take blood-thinning medication by mouth (oral anticoagulants)
  • People who have received botulinum toxin injections to the head, face, neck, or upper back area within the past 6 months for any reason
  • People who have a current skin infection on the face or neck, or who are currently taking antibiotics for an infection in those areas
  • People who are unable to attend follow-up visits for any reason, such as military training, deployment, or a permanent change of station (PCS)
  • People who have used any preventive headache medication in the four weeks before starting the trial
  • People who regularly take medication for any ongoing (chronic) pain condition
  • People who have a diagnosed psychiatric condition that would prevent them from completing the full trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Jacqueline S Buckley, PharmD, Naval Medical Center Camp Lejeune

Phone: (910) 443-2783

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Naval Medical Center Camp Lejeune
Registry
ClinicalTrials.gov
Start date
24 February 2023
Est. completion
24 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Headache days per month

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov