Myrosinase-activated glucoraphanin for people with Parkinson's, multiple sclerosis, and pediatric neuromuscular/degenerative conditions

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

This trial will test if bioactivated glucoraphanin taken with myrosinase can provide neuroprotective and anti-inflammatory effects in adults with Parkinson's disease or relapsing-remitting MS and in selected pediatric neuromuscular/degenerative patients.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 1 Year to 75 Years
• Sex: All
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo (Academic / other)
• Locations: 1 site (Messina)
• Trial ID: NCT07360977 on ClinicalTrials.gov

What this trial studies

The trial gives participants a bioactivated form of glucoraphanin (GRA) combined with the enzyme myrosinase to produce sulforaphane-like isothiocyanates thought to have neuroprotective, antioxidant, and anti-inflammatory actions. Adult cohorts include people with Parkinson's disease and relapsing-remitting multiple sclerosis, with eligibility requiring clinical stability and stable therapies for defined periods before entry. A pediatric cohort for clinically stable neuromuscular and degenerative conditions is also included, with dosing and monitoring adapted for children. The principal investigator holds a patent covering the buffered myrosinase-activated GRA formulation being used in this protocol.

Who should consider this trial

Good fit: Ideal candidates are adults with a confirmed Parkinson's diagnosis aged 45–75 or adults with relapsing-remitting MS age 18+ with EDSS ≤5.5 who are clinically stable and on stable treatments, as well as clinically stable pediatric patients who meet the study's pediatric inclusion criteria.

Not a fit: Patients with recent clinical instability, recent medication changes, advanced disability beyond the listed limits, or who cannot adhere to study procedures are unlikely to benefit from participation.

Why it matters

Potential benefit: If effective, the intervention could reduce neuroinflammation and provide neuroprotective effects that may slow disease-related decline or improve symptoms.

How similar studies have performed: Preclinical models of Parkinson's and MS have shown neuroprotective effects of glucoraphanin-derived isothiocyanates like sulforaphane, but robust clinical evidence in these conditions is currently limited.

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.

Where this trial is running

Messina

• IRCCS Centro Neurolesi Bonino Pulejo — Messina, Italy (Recruiting)

Study contacts

• Principal investigator: Emanuela Mazzon — IRCCS Centro Neurolesi Bonino Pulejo
• Study coordinator: Emanuela Mazzon

Conditions PARKINSON DISEASE; Multiple Sclerosis - Relapsing-remitting; Pediatric Patients Affected by Neuromuscolar and Degenerative Diseases; phytocompounds; Glucosinolates; isothiocyanate; Parkinson's disease; multiple sclerosis