Phase 3 Parkinson's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 80 years old at the time of signing the consent form.
• People who have been diagnosed with Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), with the time since first diagnosis being 7 years or less.
• People whose Parkinson's disease severity is rated between 1 and 3 (inclusive) on the Modified Hoehn-Yahr scale at the screening visit.
• People whose movement symptoms score at least 22 points on the MDS-UPDRS Part III assessment at screening.
• People who have not taken any anti-Parkinson's medications containing levodopa in the 4 weeks before screening (people who have previously taken levodopa-containing medications may be eligible after a 4-week period off those medications, confirm with trial site).
• People taking amantadine and/or anticholinergic drugs before screening, provided the dose has been stable for at least 4 weeks before screening and will remain unchanged throughout the study.
• Women who could become pregnant must have a negative pregnancy test at screening, and must agree to use an approved method of contraception for the entire duration of the study.
• People who are willing and able to give written consent, follow the study schedule, complete questionnaires, and take the study medication as required.

Who may not be able to join:

• People who have a medical condition that could interfere with full participation, including active epilepsy, a history of hemolytic anemia, pulmonary embolism, breathing difficulties, dementia, active mental health conditions, severe depression, or cancer.
• People with a history of serious heart failure (classified as New York Heart Association class 3 or 4) or a known very low heart pumping function (left ventricular ejection fraction below 30%).
• People who have had chest pain (angina), a heart attack, a stroke, a mini-stroke (TIA), certain heart or artery procedures, or a cerebrovascular accident within the 3 months before screening.
• People with a history of irregular heart rhythms, or currently uncontrolled irregular heart rhythms — including atrial fibrillation, Wolff-Parkinson-White syndrome, congenital long QT syndrome, or an abnormal heart tracing (ECG) showing a prolonged QTc interval (above 450 ms for men or above 470 ms for women).
• People who have taken dopamine receptor agonists, monoamine oxidase inhibitors, COMT inhibitors, adenosine A2A receptor antagonists, or medications that block dopamine receptors within the 4 weeks before screening (newly diagnosed patients who only took a single test dose may be eligible after a 3-day washout period, confirm with trial site).
• People with a history of drug or substance allergies that the trial doctor considers too risky, a previous allergic reaction to adenosine A2A receptor antagonists, or a suspected allergy to the study drug or any of its ingredients.
• People who plan to take certain medications that affect how the body transports drugs (specifically inhibitors or inducers of P-gp or BCRP efflux transporters) during the study.
• People with uncontrolled high blood pressure at screening, meaning a top reading above 160 mmHg or a bottom reading above 100 mmHg (the trial doctor may allow blood pressure to be re-checked before the baseline visit if it becomes well controlled, confirm with trial site).
• People with clinically significant liver problems, including certain abnormal liver function test results that the trial doctor considers meaningful.
• People who test positive for Hepatitis B, Hepatitis C, Hepatitis E, HIV, or syphilis.
• People whose Parkinson's disease has previously not responded to high-dose levodopa treatment, or who have not responded to adequate dopamine-based therapy (excluding cases related to absorption problems).
• People with significantly reduced kidney function, defined as a creatinine clearance below 30 mL/min as calculated by a standard formula at screening.
• People who the trial doctor considers to be at risk of suicide, or who answer "yes" to certain questions about suicidal thoughts or behaviours on a standard assessment scale (the C-SSRS) at screening.
• People who have severe anxiety or depression, specifically a score above 23 on the Hamilton Depression Rating Scale (HAMD-17) or above 21 on the Hamilton Anxiety Rating Scale (HAMA) at screening.
• People with significant memory or thinking difficulties, based on their MMSE score and level of education at screening: a score of 19 or below for people with no formal education; 22 or below for people with 6 years of education or less; or 23 or below for people with more than 6 years of education.
• People who have previously had surgery to treat Parkinson's disease.
• People who have used repetitive transcranial magnetic stimulation, transcranial direct current stimulation, biofeedback therapy, acupuncture, traditional Chinese medicine, or similar rehabilitation approaches within the 4 weeks before screening (participation may be possible after a 4-week washout period, confirm with trial site).
• People who have drunk heavily for more than 3 consecutive months in the year before screening — defined as women averaging more than 20 g of pure alcohol per day, or men averaging more than 30 g of pure alcohol per day — or people whose alcohol intake cannot be reliably estimated.
• People who have consumed excessive amounts of tea or coffee in the 4 weeks before screening, or who expect to do so during the trial — defined as 4 or more cups of tea per day or 2 or more cups of coffee per day (250 mL per cup), with specific rules about frequency applying to coffee drinkers (confirm with trial site).
• People who have actively used substances of abuse, including inhaled or injected drugs, within the 1 year before screening.
• People who have received an investigational drug as part of another clinical trial within 3 months before being randomly assigned to a treatment group in this trial.
• People whom the trial doctor considers unsuitable for this study for any other reason.

Important: Always verify eligibility with the trial site directly before applying.