Slow Parkinson progression with glucoraphanin
- Trial ID
- NCT07360977
- Official Title
- A Composition Comprising Glucoraphanin, Myrosinase and a Buffered Solution for Use in the Treatment of Neurodegenerative Diseases
- Goal
- Slow Parkinson progression with glucoraphanin
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Study Type
- INTERVENTIONAL
- Enrollment
- 300 participants
- Conditions
- PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting, Pediatric Patients Affected by Neuromuscolar and Degenerative Diseases
- Interventions
- bioactivated GRA for adult patients, bioactivated GRA for pediatric patients
Summary For Families
The goal is to reduce nerve cell damage from oxidative stress and inflammation that can drive Parkinson's progression, with the hope of protecting neurons and slowing decline. The approach gives bioactivated GRA, a mix of glucoraphanin plus myrosinase in a buffered solution that converts to sulforaphane in the body and activates the Nrf2 antioxidant and detox pathways, and it is intended to be used alongside stable anti-parkinsonian meds rather than replace levodopa. Enrollment includes several groups, notably people with Parkinson's aged 45 to 75 meeting UK Brain Bank criteria who have had stable anti-parkinsonian treatment for at least three months, adults with relapsing-remitting MS, and clinically stable pediatric patients aged 1 to 10 who weigh 5 to 30 kg. People with MRI contraindications, significant cognitive impairment (MMSE <24), major comorbidities, pregnancy, or recent changes in treatments are excluded.
Locations
- IRCCS Centro Neurolesi Bonino Pulejo, Messina, Italy
Frequently Asked Questions
- What is this trial testing?
- This trial is studying bioactivated GRA for adult patients. The goal is to reduce nerve cell damage from oxidative stress and inflammation that can drive Parkinson's progression, with the hope of protecting neurons and slowing decline. The approach gives bioactivated GRA, a mix of glucoraphanin plus myrosinase in a buffered solution that converts to sulforaphane in the body and activates the Nrf2 antioxidant and detox pathways, and it is intended to be used alongside stable anti-parkinsonian meds rather than replace levodopa. Enrollment includes several groups, notably people with Parkinson's aged 45 to 75 meeting UK Brain Bank criteria who have had stable anti-parkinsonian treatment for at least three months, adults with relapsing-remitting MS, and clinically stable pediatric patients aged 1 to 10 who weigh 5 to 30 kg. People with MRI contraindications, significant cognitive impairment (MMSE <24), major comorbidities, pregnancy, or recent changes in treatments are excluded.
- Who can participate?
- Participants must be between 1 Year and 75 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 5 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.