Phase 1 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 aged between 40 and 80 years old at the time of screening.
• People who have been diagnosed with idiopathic Parkinson's disease (Parkinson's that developed on its own, not caused by another condition), meeting specific recognised diagnostic criteria that include slowness of movement with a particular pattern, physical symptoms on one side of the body, and a clear response to levodopa medication.
• People who have been on a stable Parkinson's medication routine for at least 4 weeks before screening, or at least 12 weeks if taking a type of medication called an MAOBI.
• People who regularly experience an "OFF" period (a time when Parkinson's symptoms return or worsen, usually in the early morning), confirmed during the screening interview.
• People who experience at least 2 hours of total "OFF" time during their waking day, based on their own assessment and the investigator's judgement.
• People whose Parkinson's symptoms, when medication is working well ("ON" state), are at a certain level of severity or below on a standard rating scale (Hoehn and Yahr scale of 3 or less) (confirm with trial site).
• People who take levodopa at least 4 times a day (immediate or extended release), or at least 3 times a day if taking the specific formulations Rytary or Crexont.
• People who are able to attend the clinic on scheduled days for blood tests and assessments.
• People who score 24 or above on a standard memory and thinking test called the Montreal Cognitive Assessment.
• Women who could become pregnant and are sexually active with a male partner must use reliable contraception from consent through at least 3 months after the last dose of study medication, and must have a negative pregnancy test at screening and at the start of the study. Male participants who are sexually active with a partner who could become pregnant must agree to use condoms from consent through 3 months after the last dose, and their partners must also use a highly effective method of contraception during this period.
• People who are willing and able to follow all study requirements, including safety check-ins.
• People who are willing to provide written consent to take part.
• People whose participation has been approved by the trial's central Enrollment Authorization Committee (EAC).

Who may not be able to join:

• People whose parkinsonism has been diagnosed as a secondary or atypical form (caused by another condition or not standard Parkinson's disease).
• People who have previously had a procedure or treatment designed to deliver levodopa continuously or stimulate dopamine activity (such as Duopa or apomorphine), or brain surgery for Parkinson's (such as deep brain stimulation), or who expect to have any of these during the study.
• People whose only type of involuntary movements (dyskinesias) are of a specific pattern (diphasic, OFF state, myoclonic, or dystonic) without the more common peak-dose choreiform type.
• People whose movement complications are considered severely debilitating by the investigating doctor.
• People who, after training, are unable to tell the difference between their different movement states (OFF, ON, or ON with mild/moderate/severe involuntary movements).
• People with a significant drop in blood pressure when standing up that causes consistent symptoms or requires medication.
• People experiencing significant hallucinations that require antipsychotic medication.
• People with significant medical, surgical, psychiatric, or laboratory conditions that, in the investigator's judgement, would prevent adequate participation in the study.
• People with significant heart rhythm abnormalities on an ECG (heart tracing) at screening.
• People with a specific type of prolonged heart interval on ECG (QTcF interval above 450 milliseconds for males or 470 milliseconds for females) at screening.
• People with significant heart disease within the 2 years before screening, including: a major cardiac event (such as a heart attack or severe heart failure) within 12 weeks of screening; certain serious heart rhythm problems; uncontrolled or symptomatic atrial fibrillation; certain types of slow heart rate or heart block without a pacemaker; unexplained fainting; Brugada syndrome; or hypertrophic cardiomyopathy.
• People with an active major depressive disorder, or a history of significant impulse control disorder, as determined by the investigator or EAC. (Note: people taking antidepressants may still be considered if they have been on a stable dose for at least 8 weeks before screening.)
• People who have had active thoughts of suicide within the past year (based on a specific assessment tool), or who have attempted suicide within the past 5 years.
• People who have been diagnosed with a substance-related disorder (excluding nicotine and caffeine), including alcohol-related disorder, in the 12 months before screening.
• People who test positive at screening for certain drugs of abuse. (Note: this does not apply to medications prescribed by a doctor.)
• People with certain elevated liver enzyme or bilirubin levels in blood tests at screening.
• People with significantly reduced kidney function, as measured by specific blood test thresholds at screening.
• People who test positive for hepatitis B, hepatitis C, or HIV at screening.
• People who are currently pregnant, breastfeeding, or planning to become pregnant during the study.
• People who have previously had a bad reaction or intolerance to apomorphine.
• People who are currently taking part in, or have taken part in, another clinical research study within the last 30 days (or within 5 half-lives of the study drug, or 90 days for biological treatments).

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