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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01882062
First received: June 18, 2013
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Huntington Disease
Drug: triheptanoin oil
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between primary outcome measure and clinical parameters [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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).


Enrollment: 10
Study Start Date: May 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: triheptanoin oil

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882062

Locations
France
Brain and Spine Institute
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01882062     History of Changes
Other Study ID Numbers: C12-62
Study First Received: June 18, 2013
Last Updated: December 17, 2013
Health Authority: France: Committee for the Protection of Personnes and National Agency for Medication Safety

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Chorea
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on November 25, 2014