Have you been diagnosed
with Myotonic Dystrophy
Type 1 (DM1) or Type 2 (DM2)?
in alleviating muscle stiffness and improving quality of life.
Have you been diagnosed
with Myotonic Dystrophy
Type 1 (DM1)
or
Type 2 (DM2)?
Learn more about clinical research studies evaluating if mexiletine prolonged release (PR) is safe and effective in alleviating muscle stiffness and improving quality of life.
About the HERCULES and ATLAS Studies
The HERCULES clinical study is the first of its kind, evaluating if an investigational medication, called mexiletine prolonged release (PR), is safe and effective in alleviating muscle stiffness and improving daily activity and quality of life in people diagnosed with myotonic dystrophy type 1 or type 2 (DM1 or DM2). The study will include a total of 96 patients across different countries in Europe and the United Kingdom.
If you qualify and choose to join the study, you will be asked to stay in the study for six months and will receive either mexiletine PR or placebo (a treatment with no active ingredient). Following HERCULES, an extension study, called ATLAS, will take place for a further 18 months. If you agree to participate you will receive treatment with mexiletine PR and benefit from comprehensive safety assessments during your time in the study.
You may be eligible to participate if you are:
- At least 16 years of age*
- Genetically diagnosed with DM1 or DM2
About mexiletine
Mexiletine (NaMuscla®) is the only treatment approved (in several countries) as the first-line medication for easing the symptoms of myotonia in adults with non-dystrophic myotonic (NDM) disorders, thus improving quality of life.
While physicians and patient groups support its use as the standard of care for myotonia, which has shown to be safe and efficacious, a new once daily (QD), prolonged release (PR) formulation has been developed as a powder for reconstitution to allow for improved swallowability and tolerability, and better patient outcomes for people with myotonic dystrophy (DM). The HERCULES and ATLAS studies will evaluate the safety and effectiveness of mexiletine PR, and how it impacts quality of life in people with myotonia.
About Myotonic Dystrophy
Myotonic dystrophy is a genetic condition that causes progressive muscle weakness and myotonia, which is an inability to relax muscles after contraction. Currently, no cure or genetic treatments are available for myotonic disorders.
What Will I Be Asked To Do?
If you qualify and agree to participate in the HERCULES study, you will be randomly chosen to receive either mexiletine PR or a placebo. HERCULES is a blinded study – neither you, nor your study doctor, will know which treatment you are receiving.
Participants will take either mexiletine PR or placebo for six months orally (by mouth). Participants who complete HERCULES will then have the option to participate in a follow-up study, called ATLAS, for a further 18 months.
In the ATLAS study, all participants will receive treatment with mexiletine PR and benefit from comprehensive safety assessments during their time in the study. ATLAS will evaluate long-term safety and effectiveness of mexiletine PR. Your health and safety will be closely monitored throughout both studies.
During your participation in HERCULES, you will be required to attend six appointments and two telephone calls with the study team. In the ATLAS study you will visit the study doctor about six times and be contacted by telephone about four times.
Patients who qualify will receive study-related examinations and medication at no cost. Travel cost to and from the study visit could be covered by the sponsor if needed.
During study visits, the study team will:
- Ask about your health and how you have been feeling
- Conduct study-related examinations
- Test your blood and urine
- Ask you to complete questionnaires on your symptoms
- Provide you with study medication and instruct you how to take and track your study medication use
Why Should I Join the HERCULES and ATLAS Studies?
While we do not know the outcomes of the study, there may be potential improvement to your health. Mexiletine has been used as an antimyotonic treatment for several decades and it is considered for treatment of symptoms of myotonia.
In addition, you are contributing to the advancement of medical knowledge and potentially helping to improve treatments for yourself and others in the future by participating in this study.
HERCULES and ATLAS will provide information on the safety and effectiveness of mexiletine’s PR formulation in people with DM1 and DM2.
See If You Pre-Qualify
Are you over the age of 16? Do you have DM1 or DM2?
If you answered ‘Yes’ to all these questions, you may be eligible to participate in this study, see below for the list of all participating sites per country and their contact information to contact directly for more information.
Thank you for your interest in the HERCULES study.
Belgium
Study Site Name:
UZ Leuven
Herestraat 49 3000 Leuven Belgium
Email:
Kristl.claeys@uzleuven.be
(Prof. Kristl Claeys)
Denmark
Study Site Name:
Aarhus Universitethospital
Neurologisk Forskning
Palle Juul-Jensens Blvd. 99
Aarhus, 8200
Denmark
Denmark
Study Site Name:
Rigshospitalet
Klinik for Nerve- og Muskelsygdomme & Copenhagen Neuromuscular Center
Afsnit 8077, Copenhagen, 2100, Denmark
Email:
nicolai.rasmus.preisler@regionh.dk
(Dr. Nicolai Preisler)
Germany
Study Site Name:
Universitätsmedizin Charité
Klinik für Neurologie
Amyloidosis Center Charite Berlin (ACCB)
Charitéplatz 1 Berlin
Germany
Email:
katrin.hahn@charite.de
(PD Dr. Katrin Hahn)
Germany
Study Site Name:
Universtiy Hospital Essen
Hufelandstraße 55
45147 Essen, Germany
Email:
NME.Studie@uk-essen.de
(Prof. Dr. med. Tim Hagenacker)
Telephone:
+49201-72385563
Germany
Study Site Name:
Neuromuskuläres Zentrum Göttingen
Robert-Koch-Straße 40
37075 Göttingen, Germany
Telephone:
+49551-39065760
Italy
Study Site Name:
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
Via Francesco Sforza n. 35
20122 Milano, Italy
Email:
giacomo.comi@unimi.it
(Dr Giacomo Comi)
info@fondazionemalattiemiotoniche.org
(Prof Giovanni Meola)
Myotonic Disorders Foundation
Fondazione Malattie Miotoniche
Telephone:
+39 02 55033802
Italy
Study Site Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Largo A. Gemelli 8
00168 Roma, Italy
Email:
gabriella.silvestri@policlinicogemelli.it
(Dr Gabriella Silvestri)
Telephone:
+39 02 55033802
Italy
Study Site Name:
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Viale Oxford 81, 00133 Roma, Italy
Email:
Italy
Study Site Name:
Ospedale Niguarda – Nemo Clinical Center Piazza Ospedale Maggiore
3 Blocco Sud, Pad 7, Ala D, piano 2, 20162 Milano MI, Italy
Email:
Spain
Study Site Name:
Hospital Universitario 12 de Octubre
Avda de Cordoba, s/n
28041 Madrid, Spain
Email:
Spain
Study Site Name:
Hospital Universitario y Politécnico La Fé
Avenida Fernando Abril Martorell 106
46020 Valencia, Spain
Email:
Telephone:
+34 630306333 244153
Spain
Study Site Name:
Hospital Universitario Basurto
Montevideo Etorbidea 16-18
48013 Bilbao, Spain
Email:
United Kingdom
Study Site Name:
National Hospital for Neurology and Neurosurgery
University College London Hospitals NHS Foundation Trust
Queen Square, WC1N 3BG London, United Kingdom
Email:
n.nikolenko@nhs.net
(Dr Nikoletta Nikolenko)
United Kingdom
Study Site Name:
The Robert Jones and Agnes Hunt Orthopaedic Hospital
Gobowen
Oswestry SY10 7AG, United Kingdom
Email:
Telephone:
+44 01691 404142
United Kingdom
Study Site Name:
St George’s University Hospitals NHS Foundation Trust
Blackshaw Road
London SW17 0QT, United Kingdom
Email:
neurogenetics@stgeorges.nhs.uk
(Mark Mencias)