Since 2015, the headache and migraine clinic has given the possibility and choice to any patient to participate in a clinical study for their headache. Usually these studies are for drugs that are about to be released (phase 3) or that have already been released (phase 4).

Participation in a clinical study

Let's start things from the beginning. Clinical studies are science's most powerful weapon in the fight against disease in general. Only with studies can now find new and more effective drugs for a disease and especially for migraines. The studies are based on volunteer patients, without them nothing can be done. The new drugs that are under study should be MORE EFFECTIVE than the ones already on the market but also absolutely safe. This is the only way the competent authorities (FDA, EMA, EOF, etc., etc.) give marketing approval. Pharmaceutical companies in 90% of the cases finance a clinical study. The aim of the pharmaceutical companies is obviously also the profit they will have if their drug proves to be effective and safe and goes on sale. If the clinical study for a drug does not have good results and is not approved, the pharmaceutical company loses many millions or billions of dollars that it had invested in the study of the drug...

The Phases

The phases, i.e. the steps of studying a drug:
Phase I: 20-80 volunteers and the safety of the drug is assessed. It has a short duration (2-3 weeks).
Phase II: usually 100-300 volunteers and can last months. This is usually where the dosage that the drug will be administered is determined and the safety as well as the effectiveness of a drug is further assessed.
Phase III: usually 500 up to 3000 volunteers where a detailed record is made of the effectiveness of the drug (with electronic questionnaires) and in relation to the placebo (usually they are double blind studies, i.e. neither the patient nor the research doctor knows if they are receiving a drug for any period of time), side effects are recorded and compared with existing drugs. It is the studies that get the drug approved or not.
Phase IV: after the release of the drug additional study e.g. to compare with a drug already used for the same condition (head-to-head studies) or to record the long-term benefit of the new drug.

What are the benefits of participating in a study for a migraine patient?

•  The drug being studied is considered by researchers to be more effective than existing drugs and will probably reduce his migraines
•  Frequent free and thorough medical monitoring and laboratory testing for the duration of the study
•  He helps science and his fellow humans for a future with less pain

What are the disadvantages?

•  Commitment to regular visit to the study center and troublesome procedures such as e.g. frequent blood draw in some studies.
•  Occurrence of adverse effects from the study drug.

However, when a serious adverse event occurs in a study around the world, all investigators in all centers are informed, and the investigators inform their own patients. Specifically, in the ARISE study, which was a phase III study, which we had the pleasure of doing in Thessaloniki, there were NO serious side effects to the drug under study and most participants report a spectacular reduction in their migraines.

Conclusion

In conclusion, in the large approval studies of a drug, it has already been tested in laboratory animals and other volunteers mainly in relation to its safety. Finally, no one, neither a doctor nor the pharmaceutical industry (each for their own reasons), would want to do a study and have serious adverse effects on the participants. Both have well-founded suspicions that they are researching an effective and safe drug that will move science forward.

Control by the relevant government authorities is generally strict and supervision is continuous and all clinical trials conducted internationally should be reported at: www.clinicaltrials.gov
Clinical trials conducted in the countries of the European Union are listed at: www.clinicaltrialsregister.eu/