Clinical Study on the Safety of CNT-02 for TGCV and NLSD-M (NCT02830763) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Study on the Safety of CNT-02 for TGCV and NLSD-M
Italy, Japan2 participantsStarted 2016-09-05
Plain-language summary
This study is planning to evaluate the safety and clinical efficacy of medium-chain fatty acid capsules (food-grade CNT-02) in subjects with primary triglyceride deposit cardiomyovasculopathy (TGCV) and neutral lipid storage disease with myopathy (NLSD-M) associated with adipose triglyceride lipase (ATGL) genetic defects.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients for whom ATGL gene deletion has been previously confirmed.
. Patients who can take the investigational product orally.
. Male and female who are at least 20 years old at the time of consent.
. Patients who gave written informed consent.
Exclusion criteria
. Patients with diabetic ketoacidosis.
. Patients with the possibility of diabetic ketoacidosis (patients with poorly controlled diabetes mellitus \[HbA1c\>8.4%, NGSP\])
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The maximum walking distance in a 6-minute walk test at 3 months
Timeframe: 3 months
2
The maximum walking distance in a 6-minute walk test at 6 months
Timeframe: 6 months
Trial details
NCT IDNCT02830763
SponsorTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan