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Tests treatment safety and results for PD
Official title A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease
ClinicalTrials.gov ID: NCT07195825
What this study is testing
What is Injecting BBM-P002 into the bilateral putamen?
Injecting BBM-P002 into the bilateral putamen is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- 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
You likely can't join if
- Atypical or secondary Parkinsonism
- Have contraindications for surgery or have previously undergone brain surgery
- The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease
- Those with severe cognitive impairments
- Those with severe depression or severe anxiety
- Abnormal liver function
See the full eligibility 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
- The participants had good compliance and were able to undergo regular follow-ups. During the follow-up period, they were able to accurately complete the diary cards. Family members, guardians or caregivers could assist...
- Voluntarilyvoluntarily participated in the study and signed the informed consent form
- Atypical or secondary Parkinsonism
- Have contraindications for surgery or have previously undergone brain surgery
- The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease
- Those with severe cognitive impairments
- Those with severe depression or severe anxiety
- Abnormal liver function
- Abnormal coagulation function
- Abnormalities in infectious disease screening
- Currently undergoing antiviral treatment for hepatitis
- Suffering from unstable or severe diseases in the cardiovascular, respiratory, digestive, nervous, hematological, immune and other systems
- Suffering from malignant tumors or having a history of tumors
- Previous history of severe allergies
- Exclude those who have participated in other clinical trials within the past three months
- Had received gene therapy during the screening period
- Select those who have received stem cell treatment within the past 12 months
- Exclude those who have used other investigational drugs within the past 4 weeks
- During the screening period, if the individual had received live vaccines within the previous 2 months, or had a history of vaccination within the last 30 days, they would be excluded.
- Having a history of alcohol dependence or drug addiction
- Pregnant or lactating female participants
- The situations that were determined by the investigator to be unsuitable for inclusion in the study
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.