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:

• People who are able to understand the study and are willing to sign a consent form before any study activities begin.
• People who are able to follow the study schedule and meet the study requirements.
• Women who could become pregnant, and men whose female partners could become pregnant, who are willing to use an approved highly effective form of contraception throughout the study (such as certain hormonal contraception, an intrauterine device, surgical sterilisation, a vasectomised partner, or complete abstinence from heterosexual intercourse).
• People who agree not to share their study medication with anyone else.
• People who have been diagnosed with idiopathic Parkinson's disease, including family-related or genetic forms that respond to L-Dopa medication.
• People aged 18 to 75 years.
• People whose Parkinson's disease first appeared before the age of 65.
• People who have had Parkinson's disease for 5 years or more.
• People whose oral (tablet or liquid) Parkinson's medications have remained unchanged for at least four weeks before the study start.
• People who are currently taking both L-Dopa and a non-ergot dopamine agonist medication (in any form or dose) by mouth.
• People who have a history of motor fluctuations (changes in movement ability) related to their dopamine medication.
• People who have a history of mood or emotional fluctuations related to their dopamine medication.
• People who have certain behavioural symptoms linked to dopamine medication — such as hypomanic symptoms, impulse control difficulties, dopamine-related compulsive behaviours, or certain hallucination or psychosis-related symptoms — provided the person retains awareness and insight into their condition at the time of enrolment (confirm with trial site).

Who may not be able to join:

• People who are pregnant or breastfeeding.
• People who have had an allergic reaction or sensitivity to the study drug, similar drugs, or any of its ingredients.
• People who have taken part in another clinical trial, or are in a waiting or observation period for another trial, within the past three months.
• People with significant cognitive (thinking and memory) difficulties, specifically a score below 21 on a standard cognitive test called the MoCA.
• People experiencing severe paranoid psychosis without retained awareness or insight into their condition (though certain other behavioural or perceptual symptoms, such as impulse control disorder or illusions, are not automatically disqualifying — confirm with trial site).
• People with severe depression as defined by ICD-10 medical criteria (though mood fluctuations caused by dopamine medication are not automatically disqualifying).
• People with active thoughts of suicide where the person is not able to distance themselves from those thoughts (passive thoughts or wishes, where the person can credibly distance themselves, are not automatically disqualifying — confirm with trial site).
• People for whom intestinal L-Dopa therapy is medically contraindicated, based on the relevant prescribing guidelines for the study drug.
• People for whom placement of a feeding tube into the small intestine (PEG-J tube) is not medically possible due to gastrointestinal reasons.
• People whose Parkinson's disease is primarily tremor-based without fluctuations in response to dopamine medication.
• People who are currently using, or were very recently using, a device-assisted Parkinson's treatment — such as deep brain stimulation, a pump delivering medication directly into the gut, or an under-the-skin pump — immediately before joining the study (people who stopped a subcutaneous pump therapy may be eligible after taking oral medication for at least 3 months — confirm with trial site).
• People with an active cancer that is not in remission.

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