EUCTR2014-005112-42-NL
Active, not recruiting
Phase 1
A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (TRIHEP 3)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Huntington's disease
- Sponsor
- INSERM
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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