bioactivated GRA for adult patients for Parkinson's (NCT07360977)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 5 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has a group that receives no study treatment (you would continue your usual care) alongside the treatment groups. Because assignment is random, you have about a 3 in 6 chance (roughly 50%) of being in the no-treatment group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.