A Randomized, Parallel-Group, Single-Attack, Open-Label Study to Evaluate the Efficacy of Diclofenac Potassium and Rimegepant for the Acute Treatment of Migraine (ATOM).
This study, called ATOM, is comparing two medicines for acute migraine attacks: Voltfast (diclofenac potassium) and Vydura (rimegepant). Both are already approved and available. The main goal is to see how many people become completely pain-free within two hours of taking their assigned medicine, without needing any other pain relief. Researchers are also looking at whether other common migraine symptoms, like feeling sick or being bothered by light and sound, improve. They'll track what happens to people's headaches, if they come back, and any side effects. This helps understand which treatment might work best for stopping a migraine attack quickly and effectively.
At a glance
What is this study about?
This study, named ATOM, is a research project designed to help doctors understand more about treating migraine attacks. Migraine is a type of severe pulsatile headache that often comes with other symptoms like nausea, vomiting, and sensitivity to light and sound. The study is comparing two medicines, Voltfast (diclofenac potassium) and Vydura (rimegepant), which are both used to treat migraine attacks that are happening right now.
The main aim of this study is to see how effective these two medicines are in stopping a migraine attack completely. Specifically, the researchers want to find out what percentage of people who take one of these medicines are completely free of pain within two hours. They also want to make sure that people don't need to take any other pain relief during that time.
Beyond just pain relief, the study will also look at how well the medicines help with other bothersome migraine symptoms. This includes things like feeling sick (nausea), and being sensitive to light (photophobia) and sound (phonophobia). They will also track if headaches come back, how severe they are, whether people need to take other medicines, and importantly, any side effects people experience. By gathering all this information, doctors can get a clearer picture of which treatment might be most helpful for patients experiencing a migraine.
Key takeaways
- Compares two existing migraine medicines: Voltfast and Vydura.
- Aims to find out how quickly people become pain-free after treatment.
- Also checks for improvement in other migraine symptoms like nausea and light/sound sensitivity.
- Involves taking medicine for a single migraine attack.
- Both men and women, aged 18 and over, can participate.
- Helps improve understanding of migraine treatment for future patients.
Who may be eligible?
To join this study, you need to be at least 18 years old. There's no upper age limit mentioned, so older adults can also take part. The study is open to both men and women.
More specific details about your health and migraine history would be discussed with the study team. For example, they'd want to know details about your migraines, other health conditions you might have, and any other medicines you take.
It's important that you don't have certain other health problems or be taking specific medications, as these could affect the study results or your safety. The study team will review your medical history carefully to make sure the study is a safe and appropriate option for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you experience migraine headaches?
- Are you willing to take one of the two study medicines for a migraine attack?
- Are you happy for researchers to collect information about your migraine symptoms and any side effects?
What does participation involve?
If you decide to take part in this study, you will receive one of the two study medicines (Voltfast or Vydura) to treat a single migraine attack. This study is ‘open-label,’ meaning both you and your doctor will know which medicine you are taking. You'll take the medicine at the start of a migraine attack.
Researchers will then closely monitor how you feel for a period after taking the medicine. They will be particularly interested in whether your pain goes away within two hours and if other migraine symptoms improve. You will likely be asked to keep a diary or answer questions about your symptoms, any other medicines you take, and any side effects. The total duration of your active involvement in the study will be focused around that single migraine attack and the follow-up period shortly afterwards. There won't be long-term ongoing visits involved.
Potential risks and benefits
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Common questions
What is the main goal of this study?
The main goal is to see how many people become completely pain-free within two hours of taking one of the study medicines for a migraine attack.
What medicines are being studied?
The study is comparing Voltfast (diclofenac potassium) and Vydura (rimegepant), both used for treating migraine attacks.
Will I know which medicine I'm getting?
Yes, this is an 'open-label' study, so both you and your doctor will know which medicine you receive.
What if the medicine doesn't work?
The study will track whether or not the medicine works, and if you need any other pain relief, which is important information for researchers. You will always have access to appropriate medical care.
How long will I be involved in the study?
Your main involvement will be around one migraine attack and a short follow-up period; it's not a long-term study with many visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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