A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkins… (NCT07195825) | Clinical Trial Compass
RecruitingPhase 1
A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease
China18 participantsStarted 2025-12-27
Plain-language summary
The purpose of the study is to evaluate the safety and tolerability of BBM-P002 for stereotactic injection to treat participants with idiopathic Parkinson's Disease (PD) during the dose-limiting toxicity (DLT) observation period.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants with a diagnosis of Parkinson's disease for ≥ 5 years.
. The Hoehn-Yahr staging meets the requirements during the OFF periods.
. The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive
. During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly
. The participants agreed to postpone the neurosurgical procedures related to the indication treatment during the main study phase
. The participants agreed not to participate in any other therapeutic intervention studies during the trial period
. The participants agreed not to receive the vaccine during the main study phase
. From the screening period until at least 52 weeks after dosing, use a reliable contraceptive method
Exclusion criteria
. Atypical or secondary Parkinsonism
. Have contraindications for surgery or have previously undergone brain surgery
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since BBM-P002 is in Phase 1, the main goal is to figure out what doses are safe rather than to prove it works — does that change whether this might be the right step for me right now, or should I consider established Parkinson's treatments first?
2This trial is specifically measuring 'dose-limiting toxicities,' which means researchers are still working out how much of BBM-P002 the body can handle — what kinds of side effects are they watching for most closely, and how would those be managed if they happened to me?
3Given that this is an early-phase study still recruiting participants, what is known so far about how BBM-P002 works in the body, and is there any preliminary information that would help us assess whether it might be appropriate for my stage of Parkinson's?
4How does my current Parkinson's treatment plan interact with joining this trial — would I need to stop or adjust any existing medications, and what happens to my care if I need to withdraw?
5What does the monitoring schedule look like for this study, and how often would I need to come in for visits or tests — is that something that would be manageable given my day-to-day situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose limiting toxicity (DLT) events
Timeframe: Within 4 weeks
2
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)