Phase 3 Parkinson's Disease Trial, Recruiting

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

Who might be able to join this trial:

• You have been diagnosed with Parkinson's disease within the last 7 years, confirmed by your year of diagnosis.
• You are between 35 and 75 years old.
• Your Parkinson's symptoms are in an early-to-moderate stage (rated between 1 and 2.5 on a standard scale used by doctors, measured when your symptoms are well-controlled).
• You have already been tested to know whether you carry a specific gene variant called GBA1 (positive or negative result is fine, but the result must be known before joining).
• You have been on a stable Parkinson's medication for at least 3 months before joining the trial.
• You are able and willing to give your informed consent before any trial activities begin.
• You are able and willing to attend all trial visits and follow all study procedures for the full duration of the trial.
• You are able and willing to take the trial medication (ambroxol or a placebo) by mouth yourself.

Who may not be able to join:

• You have taken part in another clinical trial involving an experimental drug within the last 90 days.
• You have taken part in a clinical trial testing an experimental treatment specifically aimed at slowing Parkinson's disease within the last 12 months.
• You have previously had deep brain stimulation surgery.
• You have used the drug ambroxol in the past 12 months.
• You have used a drug called Exenatide within the past 12 months, or are currently taking Exenatide or similar diabetes medications (called GLP-1 agonists).
• You have difficulty swallowing that would stop you from taking the trial tablets yourself.
• You have a known allergy or sensitivity to ambroxol or any of its ingredients (which include lactose monohydrate, microcrystalline cellulose, copovidone, and magnesium stearate).
• You have a rare inherited condition affecting how your body processes certain sugars (such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption).
• You carry a specific gene mutation called LRRK2 G2019S (this must be checked before joining).
• You have a history of drug or alcohol misuse that, in the doctor's opinion, would prevent safe participation.
• You are pregnant, planning to become pregnant during the trial, or are currently breastfeeding.
• You are a woman who could become pregnant, or a man whose partner could become pregnant, and you are not willing to use highly effective contraception or abstain from sex during the trial and for 2 weeks after the last dose.
• You have a significant or unstable health condition that the doctor believes could put you at risk or affect the results, including: kidneys not working well enough (confirmed by a blood test), moderate or severe liver problems, or a major heart event (such as a heart attack or heart failure) within the last 6 months.
• You have severe depression, based on a score above 20 on a standard questionnaire called the Beck Depression Inventory-II.
• You have significant memory or thinking difficulties, based on a score below 20 on a standard test called the Montreal Cognitive Assessment (MoCA).
• You have taken certain Parkinson's medications called trihexyphenidyl or benztropine within the 30 days before starting the trial.
• If you choose to take part in an optional spinal fluid (CSF) sample procedure: you have an allergy to lidocaine or similar local anaesthetics, you are taking blood-thinning medication (other than aspirin), or you have known spinal problems that would make a lumbar puncture unsafe.

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