PARKINSON DISEASE (Disorder)Multiple Sclerosis (MS) - Relapsing-remittingPediatric Patients Affected by Neuromuscolar and Degenerative Diseases
Investigational drug(s) / intervention(s)
bioactivated GRA for adult patientsbioactivated GRA for pediatric patients
bioactivated GRA for adult patients: adult dose: 50 mg/day of bioactivated GRA for 6 months
bioactivated GRA for pediatric patients: pediatric dose: 10 mg/day of bioactivated GRA for 6 months
Study summary
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.
Eligibility
Sex
ALL
Min age
1 Year
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score — Baseline, 6 months (end of treatment), 12 months The score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. The scale is divided into four parameters: 0 (normal), 1 (mild), 2 (mild), 3 (moderate), and 4 (severe).
Hoehn and Yahr scale — Baseline, 6 months (end of treatment), 12 months Parkinson's Disease Progression Stage Scale (Stage 1 to 5). The scale is a subset of the Unified Parkinson's Disease Rating Scale, which allows for a more nuanced assessment of daily activities and non-motor symptoms in the context of disease therapy.
Expanded Disability Status Scale (EDSS) for Multiple Sclerosis patients — Baseline, 6 months (end of treatment), 12 months Evaluation of the degree of neurological disability in Multiple Sclerosis. The range of the EDSS Step includes 20 half steps from 0 to 10, with EDSS Step 0 corresponding to a completely normal examination and EDSS Step 10 to death due to MS
Cognitive and Neuropsychological Assessments: Montreal Cognitive Assessment (MoCA) and Mini-mental state examination — Baseline, 6 months (end of treatment), 12 months The MoCA is a one-page 30-point test administered in approximately 10 minutes to dectect cognitive impairment. Scores range between 0 and 30, a score of 26 or over is considered to be normal.
The mini-mental state examination (MMSE) or Folstein test is a 30-point test to identify cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age
Brief Repeatable Battery (BRB) of Neuropsychological Tests for Multiple Sclerosis patients — Baseline, 6 months (end of treatment), 12 months THE BRB consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory). Higher values represent a better outcome.
Normalized Brain Volume (NBV) — Baseline, 6 months (end of treatment), 12 months Evaluation of global brain atrophy through the measurement of total brain volume normalized for head size using high-field Magnetic Resonance Imaging (MRI). Higher values indicate better brain volume preservation, while a decrease over time indicates progression of brain atrophy.
Normalized Cortical Volume (NCV) — Baseline, 6 months (end of treatment), 12 months Evaluation of regional atrophy focusing on the cerebral cortex. Measurement of cortical gray matter volume normalized for head size using high-field MRI. This parameter is used to quantify the loss of cortical tissue specifically.
Change from Baseline in Whole-Brain Fractional Anisotropy (FA) in Multiple Sclerosis Patients — Baseline, 6 months (end of treatment), 12 months FA is a DTI-derived metric that reflects the microstructural integrity of white matter. In Multiple Sclerosis, a reduction in FA values is a marker of axonal damage and demyelination, even in Normal Appearing White Matter (NAWM).The unit of measurement is the Ratio (Scale from 0 to 1, where 1 indicates maximum diffusion/directional integrity.
Change from Baseline in Whole-Brain Mean Diffusivity (MD) in Multiple Sclerosis patients — Baseline, 6 months (end of treatment), 12 months MD measures the average magnitude of water diffusion. An increase in MD values in MS patients indicates loss of structural barriers, typically due to neurodegeneration, inflammation, or loss of myelin. This parameter provides a global index of tissue destruction.
Non-Motor Symptoms Scale (NMSS) for Parkinson patients — Baseline, 6 months (end of treatment), 12 months It assesses 30 non motor symptoms across 9 domains, with scores ranging from 0 (no symptoms) to 12 per group (severity x frequency), resulting in a total score of 0 to 360, indicating the extent of the non-motor symptom burden. Lower score indicate fewer symptoms; a negative change from baseline indicates improvement in symptoms. Mean scores vary with disease severity, reflecting increased problems with sleep disturbances, mood, cognition, gastrointestinal function, etc.
Quality of Life Assessment: Hamilton Rating Scale for Depression (HRSD) and Hamilton Anxiety Rating Scale. — Baseline, 6 months (end of treatment), 12 months Depression severity is assessed using the 17-item Hamilton Rating Scale for Depression (HRSD). Based on the total score, participants will be classified into the following levels: no depression (0-7), mild depression (8-13), moderate depression (14-18), severe depression (19-22), and very severe depression (≥23). The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire to evaluate the anxiety. The Hamilton Anxiety Rating Scale (HAM-A), which consists of 14 items, each rated on a 5-point scale. The total score, obtained by adding the individual items, ranges from 0 to 56. A score ≤17 indicates mild anxiety; 18-24 indicates mild to moderate anxiety; 25-30 indicates moderate to severe anxiety.
Parkinson's Disease Quality of Life Questionnaire (PDQ-8) — Baseline, 6 months (end of treatment), 12 months It is a patient-reported outcome measure consisting of 8 items that assesses health-related quality of life in Parkinson's disease. It includes one representative item for each domain of the original PDQ-39: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and physical discomfort. Participants rate their experiences in the previous month using a 5-point Likert scale (0 = never to 4 = always). The total score is converted into a Summary Index (SI) ranging from 0 to 100, with higher scores indicating poorer health-related quality of life.Summary Index scores were interpreted as follows: 0-20 indicating good quality of life with minimal disease impact, 21-40 mild impairment, 41-60 moderate impairment, 61-80 marked impairment, and 81-100 severe impairment of quality of life.
Parkinson's Disease Sleep Scale (PDSS-2) — Baseline, 6 months (end of treatment), 12 months The PDSS-2 is a 15-item self-administered questionnaire used to evaluate sleep disturbances and nocturnal symptoms in patients with Parkinson's Disease. It covers various domains including motor symptoms at night, sleep quality, and daytime sleepiness. Each item is scored on a 5-point Likert scale from 0 (never) to 4 (very often). The total score ranges from 0 to 60. A total score ≥ 15-18 is often considered indicative of clinically significant sleep disturbance.
Change from Baseline in EuroQol-5D-3L Index Score — Baseline, 6 months (end of treatment), 12 months The EQ-5D-3L is a standardized instrument for measuring health-related quality of life. It consists of a questionnaire with 5 item: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. These responses are converted into a single index score (utility value) using a country-specific value set.
Clinical Global Impression of Improvement (CGI-I) — Baseline, 6 months (end of treatment), 12 months The CGI-I is a clinician-rated scale that assesses how much the patient's illness has improved or worsened relative to a baseline state.It is scored on a 7-point Likert scale: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment
Patient Global Impression of Change (PGI-C) — Baseline, 6 months (end of treatment), 12 months The PGI-C is a self-reported scale reflecting the patient's belief about the efficacy of treatment and their overall change in health status since the start of the study. It uses a 7-point scale where: 1 = Very much improved; 2 = Much improved; 3 = Minimally improved; 4 = No change; 5 = Minimally worse; 6 = Much worse; 7 = Very much worse.
Trial sites (1)
Facility
City
Region
Status
IRCCS Centro Neurolesi Bonino Pulejo
Messina
Italy
Recruiting
More IRCCS Centro Neurolesi Bonino Pulejo trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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