1 Why is the COMMEND Study being carried out?
People with motor neuron disease (MND) often experience muscle cramps, for which there is currently no approved treatment. The purpose of the COMMEND Study is to assess the safety and effectiveness of an investigational product in men and women with MND who are experiencing muscle cramps. The results of this study will help determine whether the investigational product is a potential future treatment for this condition and can go forward to the next stage of clinical development.
2 How does the investigational product work?
New research suggests that cramps do not originate in the muscle. Instead they are thought to be caused by repeat “firing” of the spinal motor neurons that control muscle contractions. Researchers believe that this investigational product could prevent these motor neurons from firing, thereby reducing cramp intensity and improving quality of life.
3 How do I take the study product?
You will be given a carton containing blister packs with tablets of the study product (enough for 28 days of dosing plus extra if needed). Blister packs are commonly used to dispense many medications.
To get to the tablet, you must peel away the backing to expose the tablet and flip the open blister cavity into your hand to allow the tablet to fall out. Do not try to push the tablet through the blister material because this will damage the tablet. You should take the tablet immediately. You will not be able to tell which study product you are taking because they all look the same.
You will take one tablet of study product three times a day approximately 7 hours apart (for example, at 07:00, 14:00, and 21:00) by placing the tablet on your tongue and moving it around in your mouth until it completely dissolves. You should not swallow the tablet whole or take the tablets with water. Do not drink water for 15 minutes before and after taking the study product.
The study product may cause a burning sensation in your mouth during or after taking it. Any discomfort will most likely disappear within 15 minutes from the time the tablet dissolves in your mouth.
4 Will there be side effects from the investigational product?
All medications may cause side effects. The potential and known side effects of the investigational product are listed in the Informed Consent Form. If you do experience any discomfort during the study, you can contact the study doctor at any time to discuss the best course of action. Throughout the study, your health will be monitored continuously. Your participation in the study will be stopped if you or the study doctor have any concerns.
5 How will I know if I am eligible for this study?
To find out whether you can take part in the COMMEND Study, visit the Can I join? page. If you meet the criteria, take the pre-qualification screener. If you pre-qualify for the COMMEND Study, you will be referred to your nearest study center. At this visit, the study doctor will ask you a number of questions and perform medical tests to see whether you are right for the study and the study is right for you.
6 Where are the study centers?
There are 35 study centers across the United States taking part in this study. Find a participating study center near you.
7 What if I want to leave the study early?
It is voluntary to join the study. You can leave the study at any time for any reason. Your decision will not affect any future medical care that you receive. You may also be removed from the study if the study doctor decides that continuing is not in your best interest. If you do decide to leave, you will be asked to return to the study center to undergo final tests and assessment.
8 Do I need to ask my regular doctor before participating in this study?
We encourage you to inform your regular doctor that you are taking part in this clinical research study. There are some medications that are prohibited to take while on the study and your doctor may wish to contact the study team (with your permission) to request additional information.
9 Will I have to switch doctors?
No. The COMMEND Study will provide short-term study-related care only. Clinical research studies do not provide extended or comprehensive primary health care. Your family doctor may wish to work with the study team to best determine which treatments or medications are most appropriate for you. At the end of the study, your care will return, in full, to your regular doctor.
10 Will I be compensated for my participation in this study?
You will not receive payment for taking part in this study. However, the investigational product and all study-related care will be provided without charge. Expenses associated with taking part in this study, for instance travel to/from the study center, may be reimbursed. Please refer to the Informed Consent Form for further details.
11 Who will have access to the information collected during the study?
Your personally identifiable information (PII: eg name and address) will not be accessible to anyone who is not directly associated with this study, except with your permission or as required by law. The Sponsor (the company carrying out the study) will not have access to any PII submitted through this website. Any information gained from this study may be used for publishing results. However, this information will be combined with other participant data and will not be used to identify participants.