Phase 3 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 who have been diagnosed with idiopathic Parkinson's disease according to recognised medical diagnostic criteria, and who either (a) previously took part in a clinical trial involving a drug called buntanetap, or (b) have been receiving deep brain stimulation (DBS) treatment in a specific brain region for at least 12 months after a successful procedure.
• For the DBS group (Cohort 2): People aged between 40 and 85 years, whose Parkinson's is at a mild-to-moderate stage when their medication is working, and who score within a certain range on a standard memory and thinking test at the start of the trial (confirm with trial site).
• People who have a support person who can attend certain study visits with them.
• Women who could become pregnant must have a negative pregnancy test at the start, not be breastfeeding, and agree to use a highly reliable form of contraception during the trial and for one month after the last dose — options include hormonal contraceptives (pill, patch, injection, implant), an intrauterine device (IUD or IUS), surgical sterilisation, a vasectomised partner, or complete abstinence from heterosexual intercourse.
• Men must either be sterile, sexually inactive, or agree not to father a child during the trial and for one month after the last dose, and must use a barrier method of contraception; their female partners must also use a highly reliable contraceptive method.
• People who show no signs of current suicidal thoughts or a suicide attempt in the past month, as assessed by a standard clinical tool.
• People whose permitted medications have been at a stable dose for at least four weeks before the screening visit — this includes standard Parkinson's medications, certain memory medications, some seizure or mood medications, and mood-stabilising medications (confirm with trial site for full details).
• People with adequate vision and hearing to complete all study assessments.
• People who are in generally good health, with no other condition expected to interfere with the study.

Who may not be able to join:

• People in the first group (Cohort 1) who are currently receiving deep brain stimulation treatment (though they may be considered for the DBS group instead, if they meet those criteria).
• People with a history of certain psychiatric conditions such as schizophrenia, bipolar disorder, or major depression, unless symptoms have been mild and stable on treatment or no longer require treatment — mild or stable depression managed with certain antidepressants may be acceptable (confirm with trial site).
• People with a history of seizure disorder, unless it is well-controlled on medication (confirm with trial site).
• People with a history or current signs of certain heart rhythm problems affecting the QT interval, or a condition called torsades de pointes.
• People whose heart rate at screening is too slow (under 50 beats per minute) or too fast (over 100 beats per minute), if the study doctor considers this medically significant.
• People with uncontrolled diabetes — those with blood sugar levels above a certain threshold may not be eligible, though the study doctor will assess this individually.
• People with significantly reduced kidney function or significant liver impairment, as measured by specific blood tests.
• People with other notably abnormal blood test results, including elevated liver enzyme levels above twice the normal upper limit.
• People considered to be at immediate risk of harming themselves or others, or who have reported suicidal thoughts with intent in the past two months, or suicidal behaviour in the past six months.
• People who have had a malignant tumour (cancer) within the past year, unless they received treatment with no sign of the cancer returning — people with stable, untreated cancer are not automatically excluded (confirm with trial site).
• People with a moderate to severe alcohol or substance use disorder within the last five years.
• People who have taken part in another clinical trial involving an experimental medication within four weeks before screening, or within five half-lives of that drug, whichever is longer — unless it was confirmed they received only placebo.
• People with a learning disability or developmental delay.
• People the trial site doctor determines are otherwise not suitable for the trial.
• People with a known allergy to the study drug or any of its ingredients, which include substances such as microcrystalline cellulose, calcium phosphate, mannitol, stearic acid, hypromellose, and titanium dioxide.
• People who are currently pregnant, breastfeeding, or lactating.
• People with uncontrolled high blood pressure (above 160/95 mmHg) or low blood pressure (below 90/60 mmHg), if the study doctor considers this medically significant.

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