Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegen

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

Running, not recruitingNot a drug-phase studyRelapsing MSNCT07360977

What it found

Still running

No result yet.

What was tested

Treatment tested

  • bioactivated GRA for adult patients
  • bioactivated GRA for pediatric patients

What it measured

Main measures

  • Unified Parkinson's Disease Rating Scale (UPDRS) Total Score

    Baseline, 6 months (end of treatment), 12 months

  • Hoehn and Yahr scale

    Baseline, 6 months (end of treatment), 12 months

  • Expanded Disability Status Scale (EDSS) for Multiple Sclerosis patients

    Baseline, 6 months (end of treatment), 12 months

    Disability progression

  • Cognitive and Neuropsychological Assessments: Montreal Cognitive Assessment (MoCA) and Mini-mental state examination

    Baseline, 6 months (end of treatment), 12 months

    Thinking and memory

  • Brief Repeatable Battery (BRB) of Neuropsychological Tests for Multiple Sclerosis patients

    Baseline, 6 months (end of treatment), 12 months

    Thinking and memory

  • Normalized Brain Volume (NBV)

    Baseline, 6 months (end of treatment), 12 months

    MRI lesionsBrain volume loss

  • Normalized Cortical Volume (NCV)

    Baseline, 6 months (end of treatment), 12 months

    MRI lesionsBrain volume loss

  • Change from Baseline in Whole-Brain Fractional Anisotropy (FA) in Multiple Sclerosis Patients

    Baseline, 6 months (end of treatment), 12 months

    MRI lesionsBrain volume loss

  • Change from Baseline in Whole-Brain Mean Diffusivity (MD) in Multiple Sclerosis patients

    Baseline, 6 months (end of treatment), 12 months

    MRI lesionsBrain volume loss

  • Non-Motor Symptoms Scale (NMSS) for Parkinson patients

    Baseline, 6 months (end of treatment), 12 months

    Thinking and memoryMood and sleep

  • Quality of Life Assessment: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale.

    Baseline, 6 months (end of treatment), 12 months

    Mood and sleepQuality of life (reported by participants)

  • Parkinson's Disease Quality of Life Questionnaire (PDQ-8)

    Baseline, 6 months (end of treatment), 12 months

    Thinking and memoryWalking and mobilityQuality of life (reported by participants)

  • Parkinson's Disease Sleep Scale (PDSS-2)

    Baseline, 6 months (end of treatment), 12 months

    Mood and sleep

  • Change from Baseline in EuroQol-5D-3L Index Score

    Baseline, 6 months (end of treatment), 12 months

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • Clinical Global Impression of Improvement (CGI-I)

    Baseline, 6 months (end of treatment), 12 months

  • Patient Global Impression of Change (PGI-C)

    Baseline, 6 months (end of treatment), 12 months

Other measures (7)

  • Changes in growth parameters, anthropometric measurements and pubertal status.

    Baseline, 3 , 6 (end of the treatment) , and 12 months

    Bladder, bowel and sexual function

  • Changes in Electroencephalogram (EEG) Mean Frequency and Brain Electrical Activity.

    Baseline, 3, 6 ( end of the treatment), 12 months

    Nerve conduction testsMood and sleep

  • Assessment of Swallowing Function via Dysphagia Outcome and Severity Scale (DOSS) in pediatric patients.

    baseline and 3, 6, 12 months

  • Changes in Psychomotor Development via Griffiths Mental Development Scales 3 (GMDS-3)

    baseline and 3, 6, 12 months.

  • Pediatric Esophageal Motility and Dysphagia Assessment via High-Resolution Manometry (HRM).

    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

    baseline and 6 months (end of treatment)

    Blood or spinal fluid markersBladder, bowel and sexual functionHow the body handles the medicine

  • Transcriptomic Profile and Differential Gene Expression Analysis for PD,MS and pediatric patients.

    baseline and 6 months (end of treatment)

    Immune response

Who could take part

Relapsing MS · 1 to 75

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

  1. Status changed from Recruiting to Running, not recruiting
  2. Primary completion date changed from 19 May 2026 to 14 October 2026
  3. Completion date changed from 19 May 2026 to 1 February 2027

  1. Started

    Jan 2026

  2. Main results due

    Oct 2026

  3. Finished

    Feb 2027

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