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

IRCCS Centro Neurolesi Bonino Pulejo

Status: Enrolling

Conditions: Multiple Sclerosis (MS) - Relapsing-remitting; Pediatric Patients Affected by Neuromuscolar and Degenerative Diseases; PARKINSON DISEASE (Disorder)

Treatments: Drug: bioactivated GRA for pediatric patients; Drug: bioactivated GRA for adult patients

Study type: Interventional

Funder types: Other

Identifiers

NCT07360977

GRA-MYR-ND

PNRR-POC-2022-12376049 (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 6 patient groups

PD patients receiving only standard therapy

No Intervention group

Description:

Patients affected by Parkinson's disease receiving only standard therapy

PD patients receiving bioactivated GRA

Experimental group

Description:

Patients affected by Parkinson's disease receiving bioactivated GRA

Treatment:

Drug: bioactivated GRA for adult patients

MS patients receiving only standard therapy

No Intervention group

Description:

Patients affected by multiple sclerosis receiving only standard therapy

MS patients receiving bioactivated GRA

Experimental group

Description:

Patients affected by multiple sclerosis receiving bioactivated GRA

Treatment:

Drug: bioactivated GRA for adult patients

Pediatric patients receiving only standard therapy

No Intervention group

Description:

Pediatric patients receiving only standard therapy

Pediatric patients receiving bioactivated GRA

Experimental group

Description:

Pediatric patients receiving bioactivated GRA

Treatment:

Drug: bioactivated GRA for pediatric patients