Huntington DiseasePhase 2TRIHEP2NCT01882062
Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease
A Phase 2 study testing Triheptanoin 1g/kg/day in people with Huntington Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The purpose of this project is to study the efficacy of an anaplerotic treatment on brain energy profile evolution at an early stage of the Huntington disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Triheptanoin 1g/kg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to Jul 2013
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 5 < UHDRS < 50
- Age > 18 years
- Ability to undergo MR scanning
- Covered by french social security
Who cannot join
- Evidence of psychiatric disorder
- Attendant neurological disorder
- Contraindications to MRI (claustrophobia, metallic or material implants)
- Severe head injury
- Unable to understand the protocol
- Pregnancy
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- Failure to give informed consent
- Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent)
- Unwillingness to be informed in case of abnormal MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ETUDE PREUVE DE CONCEPT D'UNE APPROCHE ANAPLEROTIQUE UTILISANT LA SPECTROSCOPIE RMN CEREBRALE AU PHOSPHORE-31 DANS LA MALADIE DE HUNTINGTON
The purpose of this project is to study the efficacy of an anaplerotic treatment on brain energy profile evolution at an early stage of the Huntington disease.
- Conditions
- Huntington Disease
- Being tested
- Triheptanoin 1g/kg/day
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triheptanoin 1g/kg/dayDrug
| Study group | Role | What they receive |
|---|---|---|
| Triheptanoin 1g/kg/day | Experimental | All patients received Triheptanoin oil at 1g/kg/day during 1 month Receives: Drug: Triheptanoin 1g/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr
The Pi/PCr Ratio is a measure of brain metabolism and it is an index of mitochondrial oxidative regulation.
A 6-cm 31P transmit/receive surface coil (RAPID Biomedical GmbH, Rimpar, Germany) was used to collect free induction decays for 4 minutes at rest, 8 minutes during visual activation with 6-Hz red/black checkerboard flashes, and 8 minutes after stimulation. Subjects were able to focus on the flashes with a nonmagnetic mirror mounted above their eyes while all lights in the room were turned off. The Pi/PCr ratio was then calculated to determine brain response to cortical activation.
Measured: visit 1 (baseline), visit 2 (after 1 month of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882062
- Sponsor's protocol ID
- C12-62
- Acronym
- TRIHEP2
- Status last verified
- Dec 2013
- First submitted
- 18 Jun 2013
- Last updated
- 31 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Adanyeguh IM, Rinaldi D, Henry PG, Caillet S, Valabregue R, Durr A, Mochel F. Triheptanoin improves brain energy metabolism in patients with Huntington disease. Neurology. 2015 Feb 3;84(5):490-5. doi: 10.1212/WNL.0000000000001214. Epub 2015 Jan 7.
PubMed 25568297