What is the COMMEND Study?
The COMMEND Study will assess the safety and effectiveness of an investigational product in men and women with motor neuron disease (MND) experiencing muscle cramps. “Investigational” means that the product has not been approved for a particular clinical use and is still being evaluated in studies such as this one. The aim of the study is to find out whether the investigational product can reduce the frequency and severity of cramps.
Who can take part?
Approximately 150 participants in 35 study centers across the United States will take part in this study. Not everyone will be able to join the study as several inclusion criteria must be met.
How long will the study last?
The study will last approximately 3 months, during which you will be asked to attend the study center three times. The study is composed of four parts.
- Before you begin taking the study product, you will participate in a “screening visit” (Visit 1), where the study doctor will find out if you are eligible to participate in the study. If you are eligible, you will enter Period 1 and begin taking the study product three times a day for 28 days.
- After Period 1, you will return to the study clinic for a second visit (Visit 2). If you meet another set of criteria, you will enter Period 2 of the study and begin taking another study product for an additional 28 days.
- At the end of Period 2, you will return to the study clinic for a third visit (Visit 3). This will be your last visit to the study clinic.
- Approximately 7 days after this visit, you will be contacted by telephone by the study staff for one last time to see how you are doing and to ask about any new medications you are taking. After this telephone call, you will have completed the study.
In between your scheduled visits, you will receive telephone calls from the study team. The purpose of these calls is to:
- Discuss any new, or changes in, medications you are taking
- Ask how you are feeling
- Discuss how the twice-daily completion of the eDiary is going
- Assess your compliance with taking the study products
What will I take during the study?
You will be asked to take two study products during the course of the study. One of these will be a placebo (this looks like the investigational product but contains no active treatment). You, the study doctor, and the study coordinator will not know which one is the investigational product being tested, and you will not get to choose the order in which you receive them. You will be assigned by chance (like flipping a coin) to the combination that you will receive. There is a chance you may not receive an effective dose of the investigational product during this study.
What happens during visits to the study center?
During your visits to the study center, you will undergo medical tests to assess your health and determine how your body is responding to the study product. It is important to attend each appointment, so that the study team can accurately capture clinical information. If you need to reschedule an appointment, contact the study team immediately.
- Questions about you, your health, medical, disease and symptom history, current and previous medications
- Measurement of height, weight, and body mass index
- Physical examination
- Measurement of blood pressure, heart rate, and body temperature
- The air capacity of your lungs will be measured using a ‘spirometer’. You will be asked to take a deep breath, then slowly exhale into this instrument
- Questions about whether you have had any suicidal thoughts or demonstrated suicidal behavior
- Examination of the inside of your mouth
- Urine test to screen for presence of illegal and/or prescription drugs
- Pregnancy test (if appropriate)
- Electrocardiogram (ECG) will be performed. Small sticky patches will be placed on your arms, legs, and chest. These patches are connected by wires to a machine that measures the rate and regularity of your heartbeats
- Evaluation of any recent changes to your health
- Blood test
- Assessment of your pain levels, sleeping patterns, mobility, symptom severity, and how MND is affecting your life
- Administration of the study product
What else do I need to know?
Throughout the study you will be required to complete an electronic diary (eDiary) based on your muscle cramp experiences, including frequency, pain intensity, duration, location, sleep disturbance, stiffness, and daytime activity level. The eDiary should be completed twice a day. The first entry should occur in the morning around the time you take your first tablet of study product. The next entry should occur about 12 hours later when you take your last tablet of the day. Full details on how to complete the eDiary will be given to you by the study team.
How do I take part?
If you are interested in taking part in the COMMEND Study, just follow these three steps:
- Check the criteria. Participants should:
- Be 18 years of age or older
- Have been diagnosed with MND, including amyotrophic lateral sclerosis, primary lateral sclerosis, or progressive muscular atrophy
- Have experienced muscle cramps over the past 4 weeks
There are additional criteria that must be met to qualify as a participant.
- Take the pre-qualification screener. If you pre-qualify for the COMMEND Study, you will be referred to your nearest study center.
- Visit the study center, where the study team will:
- Discuss the study in more detail and explain what participation would mean for you.
- Talk through the potential benefits and risks of being involved in the study.
- Ask questions and carry out medical tests to determine whether you are right for the study and the study is right for you.
Prior to any procedures taking place, you must agree to and sign an Informed Consent Form. This document explains the study in detail, including potential risks and benefits, as well as your rights and responsibilities.
If you are eligible to participate, all study-related products, treatment and care will be provided without charge. If you do decide to participate, you may withdraw from the study at any time for any reason.