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New treatment option for Parkinson's Disease
Official title Evaluation of GM101 Injection in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT07100171
What this study is testing
- What it's testing
- The objective of this study is to assess the safety of GM101 in participants with Parkinson's disease (PD)
- Phase 1: an early, usually small safety study
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
- Clinically diagnosed patients with primary Parkinson's Disease [in accordance with the "Diagnostic Criteria for Parkinson's Disease in China"...
- Participants must be able to comprehend (fully understand the details of the clinical trial and the potential risks and benefits of the study) and...
- Age between 40 and 70 years old, inclusive, regardless of gender;
- Body weight between 40 kg and 110 kg, and Body Mass Index (BMI) between 18 kg/m² and 34 kg/m²;
- A history of Parkinson's Disease for \>= 5 years;
You likely can't join if
- Patients with atypical parkinsonian syndromes (Parkinson-plus syndromes, secondary Parkinson's syndrome, or hereditary Parkinson's syndrome).
- Patients who have previously undergone pallidotomy, deep brain stimulation (DBS) surgery, striatal/extrapyramidal system surgery, stereotactic brain...
- Patients with intracranial lesions revealed by previous CT/MRI scans, such as cerebral trauma, cerebrovascular malformations, hydrocephalus, brain...
- Patients with history of the following cardiovascular/cerebrovascular diseases: 1)Severe heart failure, unstable angina, or myocardial infarction...
- Patients with history of malignant tumors.
- Patients who have received cell therapy.
See the full eligibility criteria
Who can join
- Clinically diagnosed patients with primary Parkinson's Disease [in accordance with the "Diagnostic Criteria for Parkinson's Disease in China" released in 2016];
- Participants must be able to comprehend (fully understand the details of the clinical trial and the potential risks and benefits of the study) and voluntarily sign the informed consent form. When participants are unable...
- Age between 40 and 70 years old, inclusive, regardless of gender;
- Body weight between 40 kg and 110 kg, and Body Mass Index (BMI) between 18 kg/m² and 34 kg/m²;
- A history of Parkinson's Disease for \>= 5 years;
- Able to undergo surgical anesthesia, suitable for neurosurgical procedures under anesthesia, and capable of undergoing CT/MRI examinations;
- Hoehn-Yahr stage (Appendix IV Hoehn-Yahr Staging) at screening in the "off" state is 4-5 (including borderline values);
- MDS-Unified Parkinson's Disease Rating Scale Part III Motor Examination (MDS-UPDRS-III) score in the "off" state \>= 30; and a positive levodopa challenge test (improvement in UPDRS-III score from "off" to "on" state...
- Patients whose PD symptoms cannot be effectively controlled or who experience intolerable adverse drug reactions despite treatment with medications recommended by the "Chinese Guidelines for the Treatment of Parkinson's...
- Receiving a stable dose of anti-Parkinson's medication for at least 4 weeks prior to administration;
- Acceptable laboratory values during the screening period and prior to administration (Day 0): a) Hemoglobin \>= 100 g/L; b) Platelets \>= 100×10\^9/L; c) Aspartate aminotransferase (AST) or alanine aminotransferase...
- Participants agree not to receive any other therapeutic intervention studies during the main study phase;
- Participants agree not to participate in any other clinical studies during the study period;
- Participants agree not to receive any other vaccines within 30 days after administration;
- Participants must have the ability to live independently or the ability to clearly delegate relevant caregivers, with good compliance, and be able to attend regular follow-ups. During follow-up, participants must...
- Participants must have a pre-existing neutralizing AAV8 antibody titer \<= 1:90 as determined by testing;
- Based on the judgment of the Principal Investigator (PI), cancer-related screening will be conducted for patients who meet the .
What rules you out
- Patients with atypical parkinsonian syndromes (Parkinson-plus syndromes, secondary Parkinson's syndrome, or hereditary Parkinson's syndrome).
- Patients who have previously undergone pallidotomy, deep brain stimulation (DBS) surgery, striatal/extrapyramidal system surgery, stereotactic brain surgery, or other cerebral surgeries that might affect the observation...
- Patients with intracranial lesions revealed by previous CT/MRI scans, such as cerebral trauma, cerebrovascular malformations, hydrocephalus, brain tumors, or striatal/other brain region abnormalities that significantly...
- Patients with history of the following cardiovascular/cerebrovascular diseases: 1)Severe heart failure, unstable angina, or myocardial infarction; 2)Severe arrhythmias including but not limited to II/III-degree...
- Patients with history of malignant tumors.
- Patients who have received cell therapy.
- Patients who have received gene therapy.
- Patients with active disseminated intravascular coagulation or significant bleeding tendency within 3 months prior to consent, or those unable to discontinue antiplatelet/anticoagulant medications \>= 7 days...
- Patients who received prolonged \>= 14 days) high-dose systemic corticosteroids (prednisone \>= 20 mg/day or equivalent) or immunosuppressants within 3 months prior to consent (topical use excluded). 10,Patients with...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Changsha, 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.