MTX325 for Parkinson's (NCT07630545)
New medication slows Parkinson progression
- Trial ID
- NCT07630545
- Official Title
- A Multi-part, Adaptive Phase 1, First Time in Human Study in Healthy Volunteers to Assess Safety, Tolerability and Pharmacokinetics (PK) Following Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) of MTX325, Including Option to Assess: a Single Dose in Elderly Participants; Multiple Doses in Patients With Parkinson's Disease (PD); Central Nervous System (CNS) Penetration, Biodistribution, and Biomarkers; and the Effect of Food on PK.
- Goal
- New medication slows Parkinson progression
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Mission Therapeutics
- Study Type
- INTERVENTIONAL
- Enrollment
- 106 participants
- Conditions
- Parkinson's Disease (PD), Mild to Moderate Parkinson's Disease, Early Stage Parkinson's Disease
- Interventions
- MTX325, Placebo
Summary For Families
The goal is to learn whether a new medication called MTX325 can be developed as a disease-modifying treatment for Parkinson's disease, meaning it might change the course of the illness rather than only treating symptoms. The study is a first-in-human, multi-part trial giving MTX325 or placebo in single and repeated rising doses to healthy volunteers and to people with Parkinson's to check safety, how the body handles the drug, whether it gets into the brain and where it goes, plus early biological signs of effect; some parts use brain scans and spinal fluid tests and check the effect of food. Different parts enroll healthy adults (mostly ages 18 to 55, with a separate group 65 and older) and people with Parkinson's aged 40 to 75 who have an established diagnosis, do not have dementia, and meet the study's health and medication rules.
Locations
- Centre Hospitalier Universitaire de Lille, Institut Cœur Poumon, Lille, France
- Royal Liverpool University Hospital, Liverpool, United Kingdom
- Parexel, London, United Kingdom
- Perceptive, London, United Kingdom
- Simbec-Orion, Merthyr Tydfil, United Kingdom
- Freeman Hospital, Newcastle Upon Tyne, Newcastle, United Kingdom
- University Hospitals Plymouth NHS Trust, Derriford Hospital, Plymouth, United Kingdom
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07630545. It is the one about "New medication slows Parkinson progression". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take?
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: This trial has 4 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 4 chance (roughly 25%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying MTX325. The goal is to learn whether a new medication called MTX325 can be developed as a disease-modifying treatment for Parkinson's disease, meaning it might change the course of the illness rather than only treating symptoms. The study is a first-in-human, multi-part trial giving MTX325 or placebo in single and repeated rising doses to healthy volunteers and to people with Parkinson's to check safety, how the body handles the drug, whether it gets into the brain and where it goes, plus early biological signs of effect; some parts use brain scans and spinal fluid tests and check the effect of food. Different parts enroll healthy adults (mostly ages 18 to 55, with a separate group 65 and older) and people with Parkinson's aged 40 to 75 who have an established diagnosis, do not have dementia, and meet the study's health and medication rules.
- Who can participate?
- Participants must be between 18 Years and 75 Years.
- Where is this trial located?
- This trial is recruiting at 7 locations.
- 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 Phase 1 trial is estimated to last approximately 3 years and 7 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 4 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 4 chance (roughly 25%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Injection (minimally invasive). Confirm the full schedule with the study coordinator.