Phase 4 Migraine Trial, Recruiting NCT07301008 Sponsor: Medstar Health Research Institute Condition: Migraine
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Phase 4 Migraine Trial, Recruiting

NCT07301008
Recruiting Phase 4

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 who have had episodic migraine (with or without aura) for at least 1 year, diagnosed according to standard international headache guidelines
  • Adults aged 18 or older
  • People who have had an average of 2 to 8 moderate or severe migraine attacks per month over the last 3 months before the screening visit
  • People whose migraines first started before the age of 50
  • People whose migraine attacks typically last between 4 and 72 hours without treatment
  • People who have at least 48 hours between migraine attacks
  • People who are able to tell the difference between their migraines and other headache types, such as tension headaches or cluster headaches
  • People already on a standard migraine treatment who have been on a stable, unchanged dose for at least 3 months before joining, and who are willing to keep that regimen unchanged during the study
  • People who have previously been treated with Botox or certain migraine-specific antibody treatments (mAbs) within the last 6 months (confirm with trial site)
  • People who, during a lead-in period before the trial, experience migraines at least 75% of the time after being exposed to a known trigger — acceptable triggers include exercise, alcohol within low limits (less than one drink per day for women, less than two per day for men), air travel of no more than 12 hours, sexual activity, fasting of no more than 24 hours, stress, or weekend/let-down

Who may not be able to join:

  • People currently using certain migraine medications called gepants — specifically atogepant (taken daily), rimegepant (taken every other day), zavegepant, or ubrogepant
  • People who have regularly used opioid painkillers (such as morphine, codeine, oxycodone, or hydrocodone) or medications containing barbiturates on 5 or more days per month for 3 or more months before screening
  • People with a current diagnosis of uncontrolled, unstable, or recently diagnosed heart or cardiovascular disease, uncontrolled high blood pressure, or uncontrolled diabetes
  • People currently diagnosed with major depression requiring treatment with atypical antipsychotic medications, schizophrenia, bipolar disorder, or borderline personality disorder
  • Women who are currently pregnant, breastfeeding, or lactating

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 15 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Jessica Ailani, MD, MedStar's Georgetown University Hospital

Phone: 3015708508

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 4
Sponsor
Medstar Health Research Institute
Registry
ClinicalTrials.gov
Start date
9 September 2025
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Percentage of preemptive treatments with rimegepant in which migraine with a moderate to severe headache intensity

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: 15 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