A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (TRIHEP 3)

Phase 1

• Conditions: Huntington's disease; MedDRA version: 20.0Level: PTClassification code 10070668Term: Huntington's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2014-005112-42-NL
• Lead Sponsor: INSERM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-07
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Positive genetic test with CAG repeat length =39 in HTT gene
•At least 18 years of age
•Signature of informed consent
•Covered by social security
•UHDRS score between 5 and 40
•Ability to undergo MRI scanning
•BMI between 18 and 30

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Treatment with sodium valproate
•Treatment with tetrabenazine
•Treatment with inhibitors of pancreatic lipases (e.g. orlistat)
•Hypersensitivity to triheptanoin or to one of its excipients
•Additional major comorbidities
•History of severe head injury
•Participation in another therapeutic trial (3 month exclusion period)
•For women of childbearing age, the absence of two forms of effective contraception (with the exception of those who are abstinent)
•For men, the absence of an effective form of contraception (e.g. a condom) throughout the study period
•Pregnancy or breastfeeding
•Inability to understand information about the protocol
•Persons deprived of their liberty by judicial or administrative decision
•Adult subject under legal protection or unable to consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified