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: 18.0Level: PTClassification code 10070668Term: Huntington's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disorders

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-22
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

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