Huntington Disease Clinical Trial
— REVHDOfficial title:
Metabolic Intervention Using Resveratrol in Patients With Huntington Disease
NCT number | NCT02336633 |
Other study ID # | P130918 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | January 2020 |
Verified date | August 2019 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the therapeutic potential of Resveratrol on the caudate volume in HD patients, using volumetric MRI.
Status | Completed |
Enrollment | 102 |
Est. completion date | January 2020 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | Institut du Cerveau et de la Moelle, Hôpital de la Pitié Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rate of caudate atrophy | Measurement of the rate of caudate atrophy before and after one year of treatment with resveratrol in early affected HD patients using volumetric MRI. | 1 year | |
Secondary | UHDRS (Unified Huntington Disease Rating Scale) | 1 year | ||
Secondary | TFC (Total Functional Capacity) | 1 year | ||
Secondary | ratio of inorganic phosphate/phosphocreatine | The benefit of resveratrol on brain energy metabolism will be evaluated by the restoration of an increased ratio of inorganic phosphate/phosphocreatine - reflecting normal brain activation - during visual stimulation, using 31P-MRS will be assessed before and after 1 year of treatment | 1 year |
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