NCT02336633

Brief Summary

The purpose of this study is to evaluate the therapeutic potential of Resveratrol on the caudate volume in HD patients, using volumetric MRI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 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

January 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

February 5, 2020

Status Verified

August 1, 2019

Enrollment Period

4.3 years

First QC Date

January 8, 2015

Last Update Submit

February 3, 2020

Conditions

Huntington Disease

Keywords

Huntington diseaseNeurodegenerative diseaseVolumetric MRI31P MR spectroscopymetabolismCaudate atrophy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • UHDRS (Unified Huntington Disease Rating Scale)

    1 year

  • TFC (Total Functional Capacity)

    1 year

  • ratio of inorganic phosphate/phosphocreatine

    1 year

Study Arms (2)

1

EXPERIMENTAL

Resveratrol (80mg/j = 4 capsules/day)

Dietary Supplement: Resveratrol

2

PLACEBO COMPARATOR

Placebo (4 capsules/day)

Other: Placebo

Interventions

ResveratrolDIETARY_SUPPLEMENT

2 capsules of 20mg in the morning and in the evening (4 capsules in total/day = 80mg/day) every day during 1 year

1
PlaceboOTHER
2

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut du Cerveau et de la Moelle, Hôpital de la Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Huntington DiseaseNeurodegenerative Diseases

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Fanny Mochel, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2015

First Posted

January 13, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2019

Study Completion

January 1, 2020

Last Updated

February 5, 2020

Record last verified: 2019-08

Locations

FR(1)