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:

• A neurologist, movement disorders specialist, or similarly experienced doctor has diagnosed the person with Parkinson's disease (either confirmed or probable).
• The person was diagnosed with Parkinson's disease at age 30 or older (there is no upper age limit).
• The person has been taking Parkinson's medication containing levodopa or a dopamine agonist (alone or in combination) for at least 2 months before the screening visit.
• Women who could become pregnant must have a negative pregnancy test confirmed at the screening visit.
• Women who could become pregnant, and men whose partners could become pregnant, must be using highly effective contraception.
• The person has provided documented informed consent to participate.
• The person meets the eligibility criteria for at least one of the active treatment arms in the trial.
• The person is randomised into the trial within 4 weeks of their screening visit (ideally within 3 weeks).
• People being re-entered into the trial after previously participating must meet specific waiting period requirements before their screening visit (confirm with trial site).

Who may not be able to join:

• The person has been diagnosed with, or is suspected of having, a different condition that causes Parkinson's-like symptoms, such as atypical parkinsonism, dystonic tremor, essential tremor, or medication-induced parkinsonism.
• The person is a known carrier of certain inherited gene mutations linked to Parkinson's disease (PRKN, PINK1, or DJ1), based on previous medical records or tests.
• The person has a clinical diagnosis of dementia, or scores below 21 on a standard memory and thinking test (called the MoCA) at the screening visit.
• The person is currently enrolled in another interventional clinical trial, or has received an experimental trial medication within the 6 months before the screening visit (with some exceptions for people being re-entered into this specific trial — confirm with trial site).
• The person is unable or unwilling to follow the study requirements.
• The person has a diagnosis of clinically significant depression, or scores above 14 on a standard depression questionnaire (called the PHQ-9) at the screening visit.
• The person has had thoughts of suicide in the year before the screening visit, as identified by specific questions on a standardised assessment tool (called the C-SSRS).
• The person has had brain surgery previously, is on a waiting list for brain surgery (including deep brain stimulation), or is currently using or waiting for advanced Parkinson's therapies such as infusion treatments.
• The person's only Parkinson's medication is a type called a monoamine oxidase-B inhibitor (MAO-BI) taken alone.
• The person has previously taken any of the trial medications within 6 months before the screening visit, or has previously had a bad reaction to any of those medications.
• The person has another serious medical condition, abnormal blood test results, a progressive neurological condition, or an uncontrolled significant illness that the investigating doctor believes could make participation harmful (for example, severe kidney failure, severe heart failure, unstable angina, uncontrolled high blood pressure, severe liver disease, uncontrolled diabetes, or severe anaemia).
• The person is pregnant, breastfeeding, or planning to become pregnant during the study or within 70 days after the last dose of the study medication.
• The person has a confirmed cancer diagnosis that currently requires active treatment, or where the cancer or its treatment may prevent them from remaining in the trial for 36 months or tolerating the study medications.
• The person has liver or bile duct disorders, or certain abnormal liver function blood test results at the screening visit (confirm specific thresholds with trial site).
• The person has a history of alcohol or drug abuse or dependence within the 3 years before the screening visit.
• The person has low blood pressure readings (either sitting or when standing up) that meet specific thresholds, or has a condition called orthostatic hypotension (a significant drop in blood pressure when standing), unless the cause is considered temporary and treatable (confirm specific thresholds with trial site).

Treatment-specific exclusions — Telmisartan arm:

• The person is currently taking certain blood pressure medications known as sartans, aliskiren, ACE inhibitors, or potassium-sparing diuretics.
• The person has a known allergy or intolerance to a class of blood pressure medications called sartans.
• The person has a history of angioedema (severe swelling under the skin).
• The person has a known heart valve condition (aortic or mitral stenosis) that the investigator considers may make telmisartan unsafe.
• The person has known narrowing of the arteries supplying the kidneys (renal artery stenosis).
• The person has high potassium levels in their blood at the screening visit (confirm specific threshold with trial site).
• The person is currently taking, or has taken within the previous 6 months, a medication called lithium.

Treatment-specific exclusions — Terazosin arm:

• The person is currently using certain medications called alpha blockers (other than tamsulosin), including some natural supplements with a similar effect such as yohimbine.
• The person has a rare inherited condition affecting how the body processes certain sugars, including galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
• The person has a known sensitivity to a class of medications called quinazolines, which includes certain prostate and cancer medications (confirm specific medications with trial site).

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