NCT01696708

Brief Summary

The purpose of this project is to study brain energy profile evolution at different stages of the Huntington disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 6, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 10, 2025

Status Verified

September 1, 2012

Enrollment Period

2.9 years

First QC Date

September 20, 2012

Last Update Submit

December 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ratio of Inorganic Phosphate (Pi) over phosphocreatine (PCr): Pi/PCr

    31P-MRS allows quantification of high-energy phosphate metabolites such as phosphocreatine and inorganic phosphate

    2 years

Secondary Outcomes (2)

  • Correlation between primary outcome measure and clinical parameters

    2 years

  • Study of longitudinal changes in Pi/PCr ratio over time.

    2 years

Study Arms (2)

Patients

OTHER

31-Phosphorus RMN Spectroscopy

Other: 31-Phosphorus RMN Spectroscopy

Volunteers

OTHER

31-Phosphorus RMN Spectroscopy

Other: 31-Phosphorus RMN Spectroscopy

Interventions

PatientsVolunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • UHDRS \< 50
  • Age \> 18 years
  • Ability to undergo MR scanning
  • Covered by french social security

You may not qualify if:

  • 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
  • Unwillingness to be informed in case of abnormal MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brain and Spine Institute (ICM)

Paris, 75013, France

Location

Related Publications (2)

  • Adanyeguh IM, Monin ML, Rinaldi D, Freeman L, Durr A, Lehericy S, Henry PG, Mochel F. Expanded neurochemical profile in the early stage of Huntington disease using proton magnetic resonance spectroscopy. NMR Biomed. 2018 Mar;31(3):10.1002/nbm.3880. doi: 10.1002/nbm.3880. Epub 2018 Jan 9.

  • 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.

MeSH Terms

Conditions

Huntington Disease

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Fanny Mochel, MD, PhD

    INSERM UMR S975 Institut du Cerveau et de la Moelle, AP-HP Département de Génétique, Université Pierre et Marie Curie, Paris France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

October 1, 2012

Study Start

December 6, 2012

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 10, 2025

Record last verified: 2012-09

Locations