Not recruiting

Study on Diclofenac Potassium and Rimegepant for Treating Migraine in Patients

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effectiveness of two medications, Diclofenac Potassium and Rimegepant, for the acute treatment of migraine. Migraine is a type of headache that can cause severe throbbing pain or a pulsing sensation, usually on one side of the head, and is often accompanied by nausea, vomiting, and extreme sensitivity to light and sound. The purpose of the study is to evaluate how well these medications work in relieving migraine pain.

Participants in the study will be randomly assigned to receive either Diclofenac Potassium, Rimegepant, or a placebo. Diclofenac Potassium is provided as an oral solution, while Rimegepant is given as an oral lyophilisate, which is a form that dissolves in the mouth. The study will observe the participants over a single migraine attack to see how quickly and effectively the medications relieve pain. The main goal is to determine the percentage of participants who become pain-free two hours after taking the medication, without needing any additional rescue medication.

Throughout the study, researchers will also monitor other factors such as the absence of the most bothersome symptom, changes in headache intensity, and any side effects experienced by participants. The study aims to provide valuable information on the effectiveness of these treatments for people suffering from migraines, potentially offering new options for managing this condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have a history of migraine for at least 12 months. The patient should be between 18 and 65 years old and have experienced no more than 12 migraine attacks per month in the last three months.
The patient must provide informed consent before any study-specific activities or procedures begin.
Step 2
Treatment administration
The patient will receive one of the following medications for the acute treatment of migraine: VOLTFAST 50 mg (diclofenac potassium) as an oral solution or VYDURA 75 mg (rimegepant) as an oral lyophilisate.
Both medications are administered orally. The patient will take the medication at the onset of a migraine attack.
Step 3
Monitoring and evaluation
The primary objective is to assess the percentage of patients who become pain-free two hours after treatment, without using any additional medication.
Secondary evaluations include the absence of the most bothersome symptom at two hours, headache intensity, the need for additional medication, and the presence of symptoms such as nausea, sensitivity to light (photophobia), and sensitivity to sound (phonophobia).
Step 4
Follow-up
The study will monitor any adverse events experienced by the patient during the trial.
The trial is expected to conclude by December 31, 2025.

Who can join the trial?

4 criteria

Have a history of migraine (with or without aura) for at least 12 months before the screening. An aura is a set of sensory disturbances that can happen before a migraine, like seeing flashes of light or feeling tingling.
Must agree to participate by providing informed consent before starting any study-related activities. Informed consent means you understand the study and agree to take part.
Be between 18 and 65 years old at the time of screening.
Have no more than 12 migraine attacks per month, with each attack causing moderate to severe headache pain, in the last 3 months.

Who cannot join the trial?

7 criteria

Individuals who are not experiencing migraine headaches.
Individuals who are under the age of 18 or over the age of 65.
Individuals who are not willing to follow the study procedures.
Individuals who have used any other medication for migraine relief within 24 hours before the study.
Individuals who have a history of allergic reactions to the study medication.
Individuals who are pregnant or breastfeeding.
Individuals who have any other medical condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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Rigshospitalet
Verified
Copenhagen, Denmark

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Investigated drugs

Diclofenac Potassium
is a medication used to relieve pain and reduce inflammation. In this trial, it is being tested for its effectiveness in treating acute migraine attacks. It works by blocking substances in the body that cause inflammation and pain.
Rimegepant
is a medication used to treat migraine headaches. It helps to relieve pain and other symptoms of a migraine attack. Rimegepant works by blocking a protein in the brain that is involved in the development of migraine headaches.

What is already known about the treatment

Diclofenac Potassium
This medication is administered orally and is currently being studied for its effectiveness in treating acute migraine attacks. It is well-established in medical literature as a non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and inflammation. Diclofenac works by inhibiting enzymes called cyclooxygenases, which are involved in the production of substances that cause inflammation and pain. It is classified pharmacologically as an NSAID.
Rimegepant
This medication is also taken orally and is being evaluated for its role in the acute treatment of migraines. Rimegepant is a newer medication in medical literature, known as a calcitonin gene-related peptide (CGRP) receptor antagonist. It works by blocking the action of CGRP, a protein that plays a key role in migraine attacks. Rimegepant is classified as a CGRP receptor antagonist.

Investigated diseases

Migraine – A migraine is a type of headache characterized by intense, throbbing pain, usually on one side of the head. It often comes with additional symptoms such as nausea, vomiting, and sensitivity to light and sound. Migraines can last for hours or even days and may be preceded by warning symptoms known as aura, which can include visual disturbances or tingling sensations. The exact cause of migraines is not fully understood, but they are believed to involve changes in brain chemicals and nerve pathways. Triggers can include stress, certain foods, hormonal changes, and environmental factors. Migraines can significantly impact daily activities and quality of life during an episode.