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Resveratrol and Huntington Disease (REVHD)

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ClinicalTrials.gov Identifier: NCT02336633
Recruitment Status : Recruiting
First Posted : January 13, 2015
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Huntington Disease Dietary Supplement: Resveratrol Other: Placebo Not Applicable

Detailed Description:

Thanks to neuroimaging biomarkers already validated in HD and the newly identified metabolic brain biomarkers using 31P-MRS, we can test for a reduction in neurodegeneration among HD patients resulting from an improvement in brain energy profiles with resveratrol.

We plan to randomize 102 early affected HD patients (with a maximum of 120 included patients) in France (5≤UHDRS≤40) in a randomized, double-blind, controlled study. Patients will receive either resveratrol at 80 mg (n=51), or placebo (n=51) for 12 months. Clinical benefit will be respectively evaluated by UHDRS and neuropsychiatric questionnaires; biological tolerance will be evaluated by routine biochemical blood tests and plasma measurements of resveratrol, these three factors will be tested every three months.

The primary end-point will be the measure of the rate of caudate atrophy - the most sensitive biomarker identified to date in HD - after one year of treatment with resveratrol in early affected HD patients using volumetric MRI as we described.

Secondary end-points include:

The clinical and biological tolerance of resveratrol in HD patients will be evaluated by (i) neuropsychiatric questionnaires: Starkstein apathy scale, Hospital Anxiety and Depression Scale (HADS), Systems Behaviour Inventory (FrSBe) and SF36, (ii) a cognitive test; Symbol Digit Modalities Test (SDMT) and (iii) routine biochemical tests The clinical benefit of resveratrol will be evaluated by a decrease in the progression of the UHDRS over a year of treatment 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 as we described The progression of caudate atrophy over a year will be correlated with the changes in brain energy profile as well as changes in the progression of the UHDRS.

The compliance of treatment and peak in plasmatic concentration through plasma measurements of resveratrol.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolic Intervention Using Resveratrol in Patients With Huntington Disease
Study Start Date : July 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: 1
Resveratrol (80mg/j = 4 capsules/day)
Dietary Supplement: Resveratrol
2 capsules of 20mg in the morning and in the evening (4 capsules in total/day = 80mg/day) every day during 1 year

Placebo Comparator: 2
Placebo (4 capsules/day)
Other: Placebo



Primary Outcome Measures :
  1. rate of caudate atrophy [ Time Frame: 1 year ]
    Measurement of the rate of caudate atrophy before and after one year of treatment with resveratrol in early affected HD patients using volumetric MRI.


Secondary Outcome Measures :
  1. UHDRS (Unified Huntington Disease Rating Scale) [ Time Frame: 1 year ]
  2. TFC (Total Functional Capacity) [ Time Frame: 1 year ]
  3. ratio of inorganic phosphate/phosphocreatine [ Time Frame: 1 year ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336633


Contacts
Contact: Magali Barbier +33 (0)1 57.27.41.91 magali.barbier@icm-institute.org

Locations
France
Institut du Cerveau et de la Moelle, Hôpital de la Pitié Salpêtrière Recruiting
Paris, France, 75013
Contact: Tiffany Monnier, M Scs         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Fanny Mochel, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02336633     History of Changes
Other Study ID Numbers: P130918
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Huntington disease
Neurodegenerative disease
Volumetric MRI
31P MR spectroscopy
metabolism
Caudate atrophy

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors