NL-OMON43815
Completed
Phase 2
A comparative phase2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in Huntington's Disease (HD) - TRIHEP 3 in HD
The French National Institute of Health and Medical Research (Inserm)0 sites50 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Huntington's Disease
- Sponsor
- The French National Institute of Health and Medical Research (Inserm)
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 2 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
- •\- UHDRS score between 5 and 40
- •\- Ability to undergo MRI scanning
Exclusion Criteria
- •\- hypersensitivity to triheptanoin or to one of its excipients
- •\- additional psychiatric or neurological conditions
- •\- severe head injury
- •\- farticipation in another therapeutical trial ( 3 months 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
- •\- pnability to understand information about the protocol
- •\- persons deprived of their liberty by judicial or unable to consent
- •\- adult subject under legal protection or unable to consent
Outcomes
Primary Outcomes
Not specified
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