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Study on Reducing Chronic Migraine Days with CGRP Antibodies and Botulinum Toxin A in Adults Aged 18-70

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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 effects of a combination treatment for individuals with chronic migraine. Chronic migraine is a condition characterized by frequent and severe headache episodes. The study will use a combination of medications, including onabotulinumtoxin A (commonly known as Botox) and a group of drugs called CGRP monoclonal antibodies (CGRP mAbs). The specific CGRP mAbs being studied are fremanezumab (also known as Ajovy), galcanezumab (Emgality), and erenumab (Aimovig). These medications are designed to help reduce the number of migraine days experienced by patients.

The purpose of the study is to assess how effective the combination of CGRP mAbs and onabotulinumtoxin A is compared to using CGRP mAbs alone. Participants will receive either the combination treatment or a treatment with CGRP mAbs and a placebo. The study will last for 12 weeks, during which the number of migraine days each participant experiences will be monitored. The goal is to see if the combination treatment can significantly reduce the frequency of migraines compared to the single treatment.

Participants in the study will receive their treatments through injections. Onabotulinumtoxin A will be administered as an intramuscular injection, which means it is injected directly into the muscle. The CGRP mAbs will be given as subcutaneous injections, meaning they are injected just under the skin. The study aims to provide valuable information on whether this dual therapy approach can offer better relief for those suffering from chronic migraines.

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 trial
Upon joining the trial, you will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving the different treatments being tested.
Step 2
Treatment administration
You will receive a combination of medications designed to help reduce the number of migraine days you experience each month. These medications include fremanezumab, galcanezumab, or erenumab, which are given as a subcutaneous injection (an injection under the skin).
Additionally, you may receive onabotulinumtoxin A (also known as botulinum toxin type a) as an intramuscular injection (an injection into the muscle).
The treatment will be administered over a period of 12 weeks. The exact dosage and frequency of the injections will be determined by the study protocol and communicated to you by the study team.
Step 3
Monitoring and follow-up
Throughout the 12-week treatment period, your progress will be closely monitored. This will involve regular check-ins with the study team to assess the effectiveness of the treatment and to record any side effects or changes in your condition.
You will be asked to keep a diary of your migraine days and any other symptoms you experience. This information is crucial for evaluating the success of the treatment.
Step 4
End of treatment evaluation
At the end of the 12-week treatment period, a final evaluation will be conducted. This will include a review of your migraine diary and any other relevant health information.
The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who can join the trial?

7 criteria

Provide a signed written consent form, which means you agree to follow the study's rules and requirements.
Be between the ages of 18 and 70 at the time you sign the consent form.
Have a diagnosis of chronic migraine according to the International Classification of Headache Disorders version 3.
Meet the requirements for treatment with CGRP mAbs (a type of medication for migraines) as described in the medication guidelines.
Meet the requirements for treatment with BTA (Botulinum Toxin A, another type of migraine treatment) as described in the medication guidelines.
Have not used CGRP mAbs or BTA before.
If you are a woman who can have children, you must use a highly effective method of birth control as defined in the study guidelines.

Who cannot join the trial?

3 criteria

Patients who do not have Chronic Migraine cannot participate. Chronic Migraine means having headaches on 15 or more days each month, with at least 8 of those days being migraines.
Patients who are not within the specified age range cannot participate. The age range for this study is from 18 to 65 years old.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like pregnant women, children, or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helse Bergen HF
Bergen, Norway
Responsive
Sykehuset Oestfold HF Kalnes
Graalum, Norway
Responsive
Universitetssykehuset Nord-Norge HF
Tromsø, Norway

Trial locations

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Investigated drugs

CGRP mAbs
are a type of medication used in this study to help reduce the number of migraine days each month. They work by blocking a protein in the body called CGRP, which is involved in causing migraines. By preventing this protein from working, CGRP mAbs can help decrease the frequency and severity of migraine attacks.
Onabotulinumtoxin A
is another medication used in this study, commonly known as Botox. It is injected into specific muscles and works by relaxing them. In the context of migraines, it helps to prevent headaches by reducing muscle tension and blocking pain signals. This medication is used in combination with CGRP mAbs to see if it provides better relief from chronic migraines compared to using CGRP mAbs alone.

What is already known about the treatment

CGRP mAbs
This medication is administered through injections and is currently being studied for its effectiveness in treating chronic migraines. It works by blocking a protein called CGRP, which is involved in the transmission of pain signals in the brain. CGRP mAbs are classified as monoclonal antibodies and are being evaluated for their ability to reduce the number of migraine days each month.
Onabotulinumtoxin A
This medication is given through intramuscular injections and is already used in medicine to treat chronic migraines. It helps by relaxing muscles and blocking the release of certain chemicals that cause pain. Onabotulinumtoxin A is classified as a neurotoxin and is known for its ability to prevent headaches in people who suffer from chronic migraines.

Investigated diseases

Chronic Migraine – Chronic Migraine is a neurological condition characterized by experiencing headaches on 15 or more days per month, with at least 8 of those days involving migraine features. These migraine features can include throbbing pain, sensitivity to light and sound, nausea, and visual disturbances. The condition often begins with episodic migraines that gradually increase in frequency over time. As the frequency of headaches increases, the distinction between individual migraine attacks and a continuous headache state can become blurred. The progression of Chronic Migraine can lead to significant impairment in daily activities and quality of life. It is a condition that requires careful management to reduce the frequency and severity of migraine days.