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 range20 Years

SexALL

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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 \[HbA1c\>8.4%, NGSP\])
✕. Patients with terminal malignancy.
✕. Pregnant or lactating women.
✕. Patients who do not consent to using contraception while participating in this study.
✕. Patients allergic to MCT oil.
✕. Patients participating in other clinical trial.
✕. Otherwise, patients determined to be ineligible for this study by the investigator or sub-investigator.

What they're measuring

The maximum walking distance in a 6-minute walk test at 3 months

Timeframe: 3 months

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Primary Triglyceride Deposit Cardiomyovasculopathy (TGCV) trials