Phase 2
N=10
Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease
Huntington Disease
Bottom Line
View on ClinicalTrials.gov: NCT01882062 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr — 0.44; 0.43; 0.44; 0.42 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Triheptanoin 1g/kg/day (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr |
0.44; 0.43; 0.44; 0.42; 0.45; 0.42 | — |
| SECONDARY Correlation Between Primary Outcome Measure and Clinical Parameters |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 5 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
Data sourced from ClinicalTrials.gov (NCT01882062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.