Doctor discussing a migraine research study with a patient

Menstrual Migraine Research Study

Acute Treatment of Migraine Attacks Occurring During the Perimenstrual Period Research Study
Benefits of Joining a Clinical Trial
  • Participants will receive study-related care, including a physical examination and clinical laboratory testing.
  • Study-related medical exams and procedures will be provided at no cost during study visits.
  • All assessments and procedures are conducted under the supervision of clinical investigators and medical monitors.
Gender
Female
Ages
18+
Compensation
$549.00
Status
Enrolling
See If You Qualify

Overview

Migraine Research Study: Acute Treatment During the Perimenstrual Period

Migraines that occur around the time of a menstrual period can be especially disruptive and difficult to manage. This clinical research study is looking at a potential treatment option for menstrual migraine, which is migraine pain that happens during the days before or during a menstrual cycle.

The study medication being evaluated is a combination of two medicines (meloxicam and rizatriptan) that are designed to treat migraine attacks when they happen. Researchers want to learn how well this treatment works and how safe it is for women who experience migraines linked to their menstrual cycle.

During the study, participants may receive either the study medication or a placebo, which looks like the study medication but does not contain active medicine. Comparing the two helps researchers better understand how effective the treatment may be.

The goal of this study is to determine whether the investigational treatment can safely and effectively relieve migraine symptoms that occur during the perimenstrual period.

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About the Study

The primary objective of this research is to evaluate the efficacy of an investigational treatment compared to placebo in the acute treatment of migraine attacks occurring during the perimenstrual period. Additionally, the study aims to evaluate the safety and tolerability of said treatment and its effect on dysmenorrhea symptoms (menstrual pain). Participants will be randomly assigned to receive either the investigational treatment or a matching placebo for at-home treatment of a single qualifying menstrual migraine attack.

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Who Can Join

You may be eligible to participate if you:

  • Are female, 18 years or older, with regular menstrual cycles between 21 and 35 days
  • Have an established diagnosis of migraine (for at least 1 year)
  • Have a history of 2 to 8 migraine attacks on average per month in each of the previous 3 months
  • Have had migraines that last more than 3 hours if untreated
  • Have a minimum 6-month history of menstrual migraine (occurring -2 to +3 days of menstruation)
  • Experience dysmenorrhea (menstrual pain) at the onset of menstruation in at least 2 of the 3 menstrual periods before screening
  • Have a body weight of at least 45 kg and a BMI of 40 kg/m² or less.

You may not be eligible if you:

  • Have a history of cluster headaches or hemiplegic migraine
  • Experience more than 8 migraine attacks per month
  • Have another neurological condition that causes migraines
  • Have a history of significant cardiovascular disease, including myocardial infarction, stroke, or uncontrolled hypertension
  • Use opioid or barbiturate pain medications more than 4 days per month
  • Take certain medications that affect blood clotting or migraine prevention
  • Have a history of gastrointestinal bleeding or perforation related to previous NSAID therapy
  • Have a known hypersensitivity or allergy to meloxicam, rizatriptan, or other NSAIDs (e.g., aspirin)
  • Are currently pregnant or breastfeeding
  • Use marijuana without a medical card

*Additional criteria may apply

Not sure if you qualify?
A member of our study team will review your medical history and medications with you to determine if this study may be a good fit.

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What to Expect

Study Duration
The study lasts about 14 weeks.

Study Visits
Participants will attend 3 in-person study visits at the research site.

Compensation
Participants may receive compensation up to $550 for their time and participation.

Compensation includes $100 per visit plus $250 for completing the electronic diary requirements.”

Procedures During the Study

Participants may be asked to:

  • Record migraine symptoms in a daily electronic diary
  • Track migraines that occur during their menstrual cycle
  • Take the study medication or placebo when a migraine occurs during the study period
  • Attend scheduled study visits so the research team can monitor health and progress
See If You Qualify

See if You Qualify.

To see if you qualify or to learn more, please complete the form

Frequently Asked Questions.

What is a Clinical Trial?

A clinical trial is a research study that evaluates new medications, devices, or treatment approaches to determine if they are safe and effective. Clinical trials help doctors and researchers develop better treatments for current and future patients. All studies follow strict safety guidelines and are carefully monitored.
Each clinical study has requirements for participants based on specific factors such as age, medical history and current health. The eligibility criteria in each study protocol are used to identify the volunteers best qualified to participate.
No. Study-related medications, tests, and medical visits are provided at no cost to you. Participation in a clinical trial should not require you to pay for study-related care.
Many studies provide compensation for time and travel. Compensation varies by study and will be explained before you decide to participate.
Health insurance is not required for most clinical trials. Study-related care is typically provided at no cost to you.
Participation is completely voluntary. You may choose to leave the study at any time, for any reason. Your decision will not affect your regular medical care or benefits.
Each study has specific eligibility criteria based on age, medical history, and other factors. The best way to find out if you qualify is to complete the eligibility form or speak with a research team member.
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