Actively Recruiting

Phase Not Applicable
Age: 1Year - 75Years
All Genders
NCT07360977

Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)

Led by IRCCS Centro Neurolesi Bonino Pulejo · Updated on 2026-01-22

300

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

Sponsors

I

IRCCS Centro Neurolesi Bonino Pulejo

Lead Sponsor

F

Fondazione Edmund Mach

Collaborating Sponsor

AI-Summary

What this Trial Is About

Glucosinolates (GLs) are phytocompounds mainly found in the Cruciferae (Brassicacea) and Moringa oleifera plants. The hydrolysis of GLs by myrosinase led to the production of isothiocyanate (ITCs). ITCs consumption was associated with different health promoting effects, including to neuroprotective, anti-oxidant and anti-inflammatory capacities. In particular, they showed neuroprotective effects in experimental models of neurodegenerative diseases, including multiple sclerosis (MS) and Parkinson's disease (PD). From different GLs, different ITCs are originated. In particular, from glucoraphanin (GRA) the ITC sulforaphane (SFN) is obtained. The PI of the project is one of the proprietor of a patent (EP2908850B1) for the application of (Rs)-GRA with myrosinase in a buffered solution for the treatment of neurodegenerative diseases. The aim of this project is to evaluate the effects of the administration of bioactivated GRA in different cohorts of adult patients, affected by MS and PD, but also a cohort of pediatric patients affected by neuromuscolar and degenerative diseases. The effects of bioactivated (Rs)-GRA administration will be evaluated with a combination of clinical evaluations and a multiomic (metabolomic, genomic) approach.

CONDITIONS

Official Title

Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)

Who Can Participate

Age: 1Year - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria for PD:

  • Male or female patients aged between 45-75 years old.
  • Clinical diagnosis of PD according to UK Brain Bank Criteria.
  • 3 months of clinical stability before study enrolment.
  • Anti-parkinsonian medication is fixed for at least 3 months prior to study entry.

Inclusion Criteria for MS:

  • Male or female patients 18 years old or older.
  • Diagnosis of RR-MS according to McDonald criteria.
  • Expanded Disability Status Scale(EDSS) lower or equal to 5.5.
  • Stable disease for at least 30 days prior to study entry.
  • Stable disease-modifying therapy for at least 3 months prior to study entry.

Common inclusion criteria for MS and PD:

  • No changes in drug treatment during 6 months-study treatment.
  • Patients understand and comply with the study procedure and are able to complete tests and examinations required by the project.
  • Written informed consent.

Inclusion criteria for pediatric patients:

  • Eligible patients are those clinically stable;
  • Age range from 1 to 10, between 5 and 30 kg.
  • Patients not involved in other clinical trials.
Not Eligible

You will not qualify if you...

Exclusion criteria for PD and MS:

  • Absolute contraindications to Magnetic Resonance Imaging (MRI).
  • Concomitant neurological disease or severe co-morbidities able to influence outcomes such as spinal injury, cancer, dementia, or other central nervous system diseases such as stroke, epilepsy or psychiatric disorders;
  • Total score of Mini-Mental State Examination (MMSE)<24.
  • Participating in other clinical trials.
  • Pregnant/lactating.

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Trial Site Locations

Total: 1 location

1

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy, 98124

Actively Recruiting

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Research Team

E

Emanuela Mazzon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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