Study on Sumatriptan and Rimegepant for Treating Nitroglycerin-Induced Headaches in Patients with Episodic Migraine

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What is this study about?

This clinical trial focuses on studying migraine, a common type of headache that can cause severe pain and other symptoms. The study will test two treatments: Sumatriptan and Rimegepant. These medications are used to relieve migraine symptoms. The trial will also involve the use of nitroglycerin, a substance that can induce headaches, to better understand how these treatments work during a migraine attack.

The purpose of the study is to observe changes in certain biochemical markers in the blood and saliva during a migraine attack and after treatment with Sumatriptan and Rimegepant. Participants will receive either Sumatriptan or Rimegepant during the trial, and their response to these treatments will be monitored. The study will help determine how these medications affect the levels of specific markers in the body, which could provide insights into their effectiveness in treating migraines.

Participants will be involved in a randomized cross-over trial, meaning they will receive both treatments at different times. The study will track the evolution of biochemical markers at four different points: before the migraine starts, at the beginning of the migraine, at the peak of the migraine, and two hours after treatment. This approach will help researchers understand the relationship between these markers and the response to migraine treatments.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose and procedures. You will be asked to sign an informed consent form, confirming your understanding and agreement to participate.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, migraine diagnosis, and frequency of headaches.

3 inducing headache

You will receive a medication called glyceryl trinitrate intravenously to induce a headache. This is part of the study to understand how migraines develop and respond to treatment.

4 treatment phase

During the headache, you will be randomly assigned to receive either sumatriptan or rimegepant orally. These medications are used to treat migraines.

Sumatriptan is typically taken as a single dose, while rimegepant is also taken as a single dose. The exact dosage will be provided by the study team.

5 monitoring and sample collection

Your response to the treatment will be monitored. Blood and saliva samples will be collected at four different times: before the headache starts, at the beginning of the headache, at the peak of the headache, and two hours after taking the migraine treatment.

These samples will help measure levels of certain substances in your body that are related to migraines.

6 cross-over phase

After a period, you will switch to the other medication (either sumatriptan or rimegepant) and repeat the treatment and monitoring process. This allows for comparison of the two treatments.

7 completion of study

Once all phases are completed, your participation in the study will end. You will receive information about the study’s findings and any relevant health information.

Who Can Join the Study?

  • Adults between 18 and 60 years old.
  • Diagnosis of migraine, with or without aura (an aura is a visual or sensory disturbance that can occur before a migraine), according to the International Classification of Headache Disorders, 3rd edition.
  • Experience headaches less than 10 days per month.
  • Must sign the Informed Consent Form (a document that explains the study and any potential risks, which you agree to by signing).

Who Cannot Join the Study?

  • Patients who are not experiencing migraine attacks.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing to comply with the study procedures.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of allergic reactions to the study medications, Sumatriptan or Rimegepant.
  • Patients who are pregnant or breastfeeding.
  • Patients who have used certain medications that might interfere with the study results.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hfkgrjlm Vcvs dxyutkxq Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.04.2025

Trial locations

Sumatriptan is a medication used to treat migraine headaches. It works by narrowing blood vessels around the brain and reducing substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms. In this trial, Sumatriptan is being tested to see how well it can relieve headaches that are artificially induced by a substance called nitroglycerin in people who suffer from episodic migraines.

Rimegepant is another medication used to treat migraine headaches. It works differently from Sumatriptan by blocking a protein in the brain that is involved in the development of migraine pain. This trial is examining how effective Rimegepant is in treating headaches caused by nitroglycerin in people with episodic migraines, and how it compares to Sumatriptan in terms of relief and changes in certain markers in the blood and saliva.

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. These headaches can be accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine attacks can last from a few hours to several days and may occur with varying frequency. Some individuals experience warning symptoms, known as aura, before the onset of a migraine. The exact cause of migraines is not fully understood, but they are believed to involve changes in brain chemicals and nerve pathways. Triggers for migraines can include stress, certain foods, hormonal changes, and environmental factors.

Trial ID:
2024-519770-38-00
Protocol code:
MAMBO-II
Trial Phase:
Therapeutic confirmatory (Phase III)

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