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Clinical Study on the Safety of CNT-02 for TGCV and NLSD-M

NCT02830763 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-07-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

    lead OTHER

Principal Investigators

  • Kenichi Hirano, MD, Ph.D · Department of Cardiovascular Medicine, Faculty of Internal Medicine, Graduate School of Osaka University, Japan

  • Elena M Pennisi, MD, Ph.D · Department of Neurology, San Filippo Neri Hospital, Rome, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-05
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • Italy
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02830763 on ClinicalTrials.gov