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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01882062 |
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Date of registration:
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18/06/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease
TRIHEP2 |
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Scientific title:
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Date of first enrolment:
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May 2013 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01882062 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Huntington Disease
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Intervention(s)
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Drug: Triheptanoin 1g/kg/day
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Primary Outcome(s)
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Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr
[Time Frame: visit 1 (baseline), visit 2 (after 1 month of treatment)]
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Secondary Outcome(s)
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Correlation Between Primary Outcome Measure and Clinical Parameters
[Time Frame: visit 1 (baseline), visit 2 (after 1 month of treatment)]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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