Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease (TRIHEP2)

February 24, 2016 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Brain and Spine Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triheptanoin 1g/kg/day
All patients received Triheptanoin oil at 1g/kg/day during 1 month
Drug: Triheptanoin 1g/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr
Time Frame: visit 1 (baseline), visit 2 (after 1 month of treatment)

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.
visit 1 (baseline), visit 2 (after 1 month of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Primary Outcome Measure and Clinical Parameters
Time Frame: visit 1 (baseline), visit 2 (after 1 month of treatment)
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).
visit 1 (baseline), visit 2 (after 1 month of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (Estimate)

June 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

February 24, 2016

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C12-62

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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