FAQs
Treatment
Has this treatment approach already been tested in previous studies?
It’s the first time that mexiletine prolonged release will be tested in DM patients. Other clinical studies have already been done with NDM patients and mexiletine.
Study Details
Where will the HERCULES study take place?
Study sites across several countries in Europe are involved (see list here). You can select the one that is most convenient for you. In general, this should be in the same country where you live.
How many patients will join the HERCULES study?
The plan is for 80 DM1 patients and 16 DM2 patients to join the HERCULES study.
What’s a placebo?
A placebo is a treatment without active ingredient.
Why is a placebo needed in the study?
This is to better assess the safety and effectiveness of the investigational medicine (mexiletine PR). Guidelines say the study should include patients that go through all the same assessments as the patients getting mexiletine PR, but without receiving the investigational medicine themselves.
After completion of the HERCULES study, participants may enter the follow‑up study ATLAS. ATLAS is an open‑label study in which participants will receive mexiletine in a prolonged‑release formulation.
Does the study doctor know which treatment I receive?
No, neither you nor your study doctor knows which treatment you are getting. This ensures that everyone taking part will be treated the same way by the medical staff.
Can I join the trial when I am pregnant?
No, you cannot join the trial when you are pregnant.
Do I have to use contraception during the study?
Yes, if you’re able to get pregnant, you have to use a safe method of contraception. Your study doctor will discuss this with you in detail.
How long and how often do I have to participate?
The study includes a 26-week treatment period. During this time, you’ll go to the study site six times and have two phone calls with the study team.
After completion of the HERCULES study, participants may enter the 18‑month open‑label follow‑up study ATLAS, in which mexiletine in a prolonged‑release formulation will be administered.
Do I have to stay overnight in the hospital?
In most study centers, no overnight stay is required and you will leave the hospital the same day. However, at one study site in Germany, a 24‑hour hospital observation is required on days when mexiletine is administered.
In all cases, participants will be informed about all study requirements and procedures before taking part in the study.
Costs
Do I have to pay for the treatment?
No, you don’t have to pay for the treatment or any of the activities involved in the study.
Do I have to pay for my travel costs?
The travel costs will be covered by the pharmaceutical company sponsoring the study. A concierge service will support you with travel arrangements (e.g. taxis, flights, hotel accommodation) if needed. The study staff will check what you need to reach the site quickly, easily and safely. Using this concierge service means you may either have travel arranged in advance at no upfront cost or arrange your own travel and be reimbursed based on submitted receipts, in accordance with local regulations and sponsor-defined cost limits.
Further information
Can I talk to my doctors about participation?
Yes, feel free to talk to your doctor about taking part in this study. At the top of this website, you can download a flyer with all relevant study information to take with you to your next appointment.
Will my doctors be kept informed about my participation in the study and its results?
If you like, your doctor will be informed about your participation in the study. Please ask the study team about this.
Can I change my mind about taking part or leave the study early?
- Yes, taking part in this study is completely voluntary. You’re free to leave the study at any time. If you withdraw your consent at a later date, this will not affect your medical care or legal rights.
- If you withdraw your consent, you’ll be checked again for your safety when you leave the study (at the “end-of-study” visit).
Can I take part in the HERCULES study if I’m already in another clinical study?
No, participation in another clinical study at the same time is not possible.
Who is the sponsor of the HERCULES study?
The sponsor of the HERCULES study is Lupin Neurosciences (www.lupin-neurosciences.com), a Specialty Pharma Division of Lupin (www.lupin.com) committed to improving the lives of patients affected by underserved neurological disorders.