Phase 2 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 between 40 and 80 years old (male or female)
• People who have been diagnosed with "Clinically Probable Parkinson's Disease" using standard medical diagnostic criteria, with symptoms that started within three years before the study screening visit
• People whose brain scan (called a DAT-scan or DaT-SPECT) shows the type of result associated with Parkinson's Disease, confirmed by a local specialist
• People in the earlier stages of Parkinson's Disease, rated at 2.5 or below on a standard scale doctors use to measure how far the condition has progressed (called the Hoehn & Yahr scale)
• People who have not yet started any medication to treat Parkinson's Disease symptoms, and whose condition is not expected to require that type of medication within 6 months of starting the study
• People whose MRI brain scan shows no signs of other movement-related conditions or problems with blood supply to the brain
• Women who are not able to become pregnant — either because of surgical procedures (such as removal of the uterus or ovaries, or tubal ligation), because they have been through menopause (no period for at least 12 months), or because they are using a highly effective method of contraception and have a negative pregnancy test at screening, maintained until at least one month after the last dose
• People who are covered by a health insurance system
• People who are able to understand and sign a consent form before any screening takes place
• People whose blood pressure and heart rate are considered normal and acceptable by the study doctor
• People whose heart tracing (ECG) results are considered normal and acceptable by the study doctor
• People whose blood test results are within the normal range, or where any results outside the normal range are considered not medically important by the study doctor

Who may not be able to join:

• People whose Parkinsonism is classified as an atypical form, or caused by medication
• People who have used any prescription, over-the-counter, or experimental medication to treat Parkinson's Disease symptoms or slow its progression within the 60 days before screening
• People who have previously taken dopamine-related Parkinson's medications (such as levodopa, dopamine agonists, amantadine, or rasagiline) for 30 or more days at any point in the past
• People with significant memory or thinking difficulties (based on a standard cognitive test score of 24 or below)
• People with an active psychiatric condition — such as mood disorders, hallucinations, or episodes of confusion — that has a strong impact on daily life and is not controlled by medication, or that occurred within the 3 months before joining
• People with a severe or poorly controlled long-term illness
• People with a significant medical history of bleeding disorders (either inherited or acquired)
• People who have been treated with Deep Brain Stimulation, or who receive continuous drug infusion therapy for Parkinson's Disease
• People with certain heart conditions, including:
  • Reduced heart pumping function confirmed by a heart ultrasound (echocardiogram)
  • Heart rhythm that cannot be measured on an ECG
  • A specific abnormal heart electrical pattern called complete left bundle branch block
  • A fitted heart pacemaker
  • A condition called long QT syndrome (inherited or with a family history of it)
  • A history of, or current, serious irregular heart rhythms (ventricular or atrial)
  • An unusually slow resting heart rate (fewer than 50 beats per minute)
  • A prolonged QT interval measurement on repeated ECG tests (confirm with trial site for specific thresholds)
  • A confirmed history of heart attack
  • Unstable chest pain (angina) within the past 12 months
  • Other significant heart conditions such as heart failure or uncontrolled high blood pressure
• People who have taken part in another experimental drug trial within 30 days before screening
• People currently taking certain medications that may interfere with how the trial drug works in the body or create safety risks, and who are unable to stop or switch to a different medication before starting the trial — this includes certain antifungal, antibiotic, antiviral, anti-seizure, and other medications (confirm with trial site for the full list)
• People currently taking medications known to affect heart rhythm (QT interval) who cannot stop or switch before starting the trial
• People currently taking certain medications that affect how drugs are transported in the body (called P-gp inducers — a long list including some HIV medications, steroids, and herbal supplements such as St. John's Wort) who cannot stop or switch before starting the trial
• People with a stomach or bowel condition that may significantly affect how the trial drug is absorbed
• People with a history of acute or chronic pancreas inflammation (pancreatitis) within the past year
• People with acute or chronic liver, pancreas, or severe kidney disease unrelated to their Parkinson's condition
• People known to be HIV positive, or who have active hepatitis B or C, or cirrhosis (note: certain stable or previously treated cases of hepatitis B or cured hepatitis C may still be eligible — confirm with trial site)
• Men who are unwilling to use an appropriate method of contraception during the study
• People who are known to be allergic to any ingredient in the trial medication
• People with any other medical condition that could interfere with the study
• People who are unable to attend scheduled study visits or follow the study requirements
• People who are under legal guardianship or judicial protection
• People who are currently excluded from joining other research studies due to a previous trial's requirements
• People for whom there is no way to make emergency contact

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