Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease

Huntington Disease Clinical Trial

— TRIHEP2  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882062
• Other study ID #: C12-62
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2013
• Last updated: December 17, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: December 2013
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes and National Agency for Medication Safety
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 5 < UHDRS < 50

• Age > 18 years

• Ability to undergo MR scanning

• Covered by french social security

Exclusion Criteria:

• Evidence of psychiatric disorder

• Attendant neurological disorder

• Contraindications to MRI (claustrophobia, metallic or material implants)

• Severe head injury

• Unable to understand the protocol

• Pregnancy

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Drug:
• triheptanoin oil

Locations

Country	Name	City	State
France	Brain and Spine Institute	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr		1 year	No
Secondary	Correlation between primary outcome measure and clinical parameters	Correlating an improvement of brain energy profile with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC).	1 year	No