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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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12 December 2020 |
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Main ID: |
NCT02336633 |
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Date of registration:
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08/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Resveratrol and Huntington Disease
REVHD |
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Scientific title:
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Metabolic Intervention Using Resveratrol in Patients With Huntington Disease |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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102 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02336633 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Fanny Mochel, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion criteria :
- Positive genetic test with CAG repeat length > or = 39 in HTT gene
- At least 18 years of age
- Signature of the informed consent
- Covered by social security
- UHDRS score between 5 and 40 (both included)
- Ability to undergo MRI scanning
Exclusion criteria :
- Hypersensitivity to resveratrol or to one of its excipients (gelatin and glycerin)
- Tetrabenazine treatment
- Neuroleptic treatments other than olanzapine at small doses (=10 mg) and Abilify®
(=15mg)
- VKA treatment (Previscan®, Sintron®, Coumadine®)
- NACO treatment (Pradaxa®, Xarelto®, Eliquis®)
- Additional psychiatric or neurological conditions
- Severe head injury
- Participation in another therapeutic trial (3 months exclusion period)
- Pregnancy and breastfeeding
- Inability to understand information about the protocol
- Persons deprived of their liberty by judicial or administrative decision
- Adult subject under legal protection or unable to consent.
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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Dietary Supplement: Resveratrol
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Other: Placebo
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Primary Outcome(s)
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rate of caudate atrophy
[Time Frame: 1 year]
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Secondary Outcome(s)
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TFC (Total Functional Capacity)
[Time Frame: 1 year]
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UHDRS (Unified Huntington Disease Rating Scale)
[Time Frame: 1 year]
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ratio of inorganic phosphate/phosphocreatine
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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