EUCTR2014-005112-42-FR
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
- 50
- 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 lenght \= 39 in HTT gene
- •\- at lmeast 18 years of age
- •\- signature of informed consent
- •\- covered by social security
- •\- UHDRS score between 5 and 40
- •\- Ability to undergo MRI scanning
- •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
Exclusion Criteria
- •\- Hypersensitivity to triheptanoin or to one of its excipients
- •\- additional psychiatric or neurological conditions
- •\- severe head injury
- •\- Participation in another therapeutical trial ( 3 months exclusion period)
- •\- Pregnancy or breastfeeding
- •\- Inability 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
- •\- Patients under tetrabenazine and neuroleptics other than atypical neuroleptics at a small dose
Outcomes
Primary Outcomes
Not specified
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