Trials / Terminated
TerminatedNCT02830763
Clinical Study on the Safety of CNT-02 for TGCV and NLSD-M
Clinical Study on the Safety and Efficacy of Medium-chain Fatty Acid Capsules (CNT-02) for Primary Triglyceride Deposit Cardiomyovasculopathy (TGCV) and Neutral Lipid Storage Disease With Myopathy (NLSD-M)
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Primary Triglyceride Deposit Cardiomyovasculopathy (TGCV)
- Neutral Lipid Storage Disease With Myopathy (NLSD-M)
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | CNT-02 | Each subject will take 2.0g of the investigational product orally 3 times a day after every meal. Unless an apparent worsening of symptoms or unacceptable adverse event occurs, the subject will continue to take the investigational product for up to 6 months. |
Timeline
- Start date
- 2016-09-05
- Primary completion
- 2019-01-01
- Completion
- 2019-01-01
- First posted
- 2016-07-13
- Last updated
- 2019-07-08
Locations
7 sites across 2 countries: Italy, Japan
Source: ClinicalTrials.gov record NCT02830763. Inclusion in this directory is not an endorsement.