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Recruiting NCT07360977

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

No phase Interventional PARKINSON DISEASE (Disorder) Multiple Sclerosis (MS) - Relapsing-remitting Pediatric Patients Affected by Neuromuscolar and Degenerative Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bioactivated GRA for adult patients, bioactivated GRA for pediatric patients.
Who it may be relevant to
Registry conditions: PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting, Pediatric Patients Affected by Neuromuscolar and Degenerative Diseases. Basic parameters: 1 year — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Composition Comprising Glucoraphanin, Myrosinase and a Buffered Solution for Use in the Treatment of Neurodegenerative Diseases

Overview

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.

Interventions

  • Drug bioactivated GRA for adult patients
    adult dose: 50 mg/day of bioactivated GRA for 6 months
  • Drug bioactivated GRA for pediatric patients
    pediatric dose: 10 mg/day of bioactivated GRA for 6 months

Primary outcome measures

  • Unified Parkinson's Disease Rating Scale (UPDRS) Total Score [Time frame: Baseline, 6 months (end of treatment), 12 months]
  • Hoehn and Yahr scale [Time frame: Baseline, 6 months (end of treatment), 12 months]
  • Expanded Disability Status Scale (EDSS) for Multiple Sclerosis patients [Time frame: Baseline, 6 months (end of treatment), 12 months]
  • Cognitive and Neuropsychological Assessments: Montreal Cognitive Assessment (MoCA) and Mini-mental state examination [Time frame: Baseline, 6 months (end of treatment), 12 months]
  • Brief Repeatable Battery (BRB) of Neuropsychological Tests for Multiple Sclerosis patients [Time frame: Baseline, 6 months (end of treatment), 12 months]
  • Normalized Brain Volume (NBV) [Time frame: Baseline, 6 months (end of treatment), 12 months]
  • Normalized Cortical Volume (NCV) [Time frame: Baseline, 6 months (end of treatment), 12 months]
  • Change from Baseline in Whole-Brain Fractional Anisotropy (FA) in Multiple Sclerosis Patients [Time frame: Baseline, 6 months (end of treatment), 12 months]
  • Change from Baseline in Whole-Brain Mean Diffusivity (MD) in Multiple Sclerosis patients [Time frame: Baseline, 6 months (end of treatment), 12 months]
  • Non-Motor Symptoms Scale (NMSS) for Parkinson patients [Time frame: Baseline, 6 months (end of treatment), 12 months]
Secondary outcome measures (7)
  • Changes in growth parameters, anthropometric measurements and pubertal status. [Time frame: Baseline, 3 , 6 (end of the treatment) , and 12 months]
  • Changes in Electroencephalogram (EEG) Mean Frequency and Brain Electrical Activity. [Time frame: Baseline, 3, 6 ( end of the treatment), 12 months]
  • Assessment of Swallowing Function via Dysphagia Outcome and Severity Scale (DOSS) in pediatric patients. [Time frame: baseline and 3, 6, 12 months]
  • Changes in Psychomotor Development via Griffiths Mental Development Scales 3 (GMDS-3) [Time frame: baseline and 3, 6, 12 months.]
  • Pediatric Esophageal Motility and Dysphagia Assessment via High-Resolution Manometry (HRM). [Time frame: baseline and 3, 6 ( end of the treatment), 12 months]
  • Metabolomics and Pharmacokinetic Analysis of Bioactive Compounds and Endogenous Metabolites in pediatric, PD and MS patients [Time frame: baseline and 6 months (end of treatment)]
  • Transcriptomic Profile and Differential Gene Expression Analysis for PD,MS and pediatric patients. [Time frame: baseline and 6 months (end of treatment)]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • IRCCS Centro Neurolesi Bonino Pulejo — Messina

Publications

  • Deuschl G, Beghi E, Fazekas F, Varga T, Christoforidi KA, Sipido E, Bassetti CL, Vos T, Feigin VL. The burden of neurological diseases in Europe: an analysis for the Global Burden of Disease Study 2017. Lancet Public Health. 2020 Oct;5(10):e551-e567. doi: 10.1016/S2468-2667(20)30190-0. PMID 33007212
  • Klomparens EA, Ding Y. The neuroprotective mechanisms and effects of sulforaphane. Brain Circ. 2019 Apr-Jun;5(2):74-83. doi: 10.4103/bc.bc_7_19. Epub 2019 Jun 27. PMID 31334360
  • Yadav SK, Soin D, Ito K, Dhib-Jalbut S. Insight into the mechanism of action of dimethyl fumarate in multiple sclerosis. J Mol Med (Berl). 2019 Apr;97(4):463-472. doi: 10.1007/s00109-019-01761-5. Epub 2019 Feb 28. PMID 30820593
  • Kamal RM, Abdull Razis AF, Mohd Sukri NS, Perimal EK, Ahmad H, Patrick R, Djedaini-Pilard F, Mazzon E, Rigaud S. Beneficial Health Effects of Glucosinolates-Derived Isothiocyanates on Cardiovascular and Neurodegenerative Diseases. Molecules. 2022 Jan 19;27(3):624. doi: 10.3390/molecules27030624. PMID 35163897
  • Schepici G, Bramanti P, Mazzon E. Efficacy of Sulforaphane in Neurodegenerative Diseases. Int J Mol Sci. 2020 Nov 16;21(22):8637. doi: 10.3390/ijms21228637. PMID 33207780
  • Lotti C, Rubert J, Fava F, Tuohy K, Mattivi F, Vrhovsek U. Development of a fast and cost-effective gas chromatography-mass spectrometry method for the quantification of short-chain and medium-chain fatty acids in human biofluids. Anal Bioanal Chem. 2017 Sep;409(23):5555-5567. doi: 10.1007/s00216-017-0493-5. Epub 2017 Jul 17. PMID 28717897
  • Garcia-Aloy M, Ulaszewska M, Franceschi P, Estruel-Amades S, Weinert CH, Tor-Roca A, Urpi-Sarda M, Mattivi F, Andres-Lacueva C. Discovery of Intake Biomarkers of Lentils, Chickpeas, and White Beans by Untargeted LC-MS Metabolomics in Serum and Urine. Mol Nutr Food Res. 2020 Jul;64(13):e1901137. doi: 10.1002/mnfr.201901137. Epub 2020 Jun 22. PMID 32420683
  • Ulaszewska, M.M., Trost, K., Stanstrup, J. et al. Urinary metabolomic profiling to identify biomarkers of a flavonoid-rich and flavonoid-poor fruits and vegetables diet in adults: the FLAVURS trial

Identifiers

NCT: NCT07360977 · GRA-MYR-ND · PNRR-POC-2022-12376049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗