A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in … (NCT05435729) | Clinical Trial Compass
CompletedPhase 1
A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease
Japan7 participantsStarted 2022-05-31
Plain-language summary
This study is an open-label of single transdermal dose of DSP-9632P to evaluate the dopamine release derived from levodopa in brain, and a randomized, double-blind, placebo-controlled, 2-way crossover of multiple transdermal doses of DSP-9632P to evaluate the safety and tolerability in patients with levodopa-induced dyskinesia in Parkinson's disease.
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject whose age is ≥ 50 and \< 80 years at the time of informed consent.
. Subject who is fully informed and understands the objectives, procedures, anticipated drug effects/pharmacological action and risks of the study and who voluntarily provides written consent to participate in the study.
. Subject who has clinically established Parkinson's disease diagnosed by MDS clinical diagnostic criteria for Parkinson's disease (2015).
. Subject who has a response to levodopa at screening in the opinion of the investigator.
. Subject who is confirmed to have dopaminergic denervation with a specific binding ratio in the striatum, obtained by dopamine transporter SPECT (123I-FP-CIT, DAT scan®) performed prior to the study or at screening, that is lower than the lower limit of 95% confidence interval of healthy adults.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Binding potential of 11C-raclopride and Dopamine D2 receptor occupancy by Positron Emission Tomography (PET) in Part A
Timeframe: 1 day
2
Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment discontinuation in Part B
. Subject who has a Hoehn \& Yahr stage ≤ III in the ON state at screening.
. Subject who has MDS-UPDRS Part IV-1 ≥ 2 and Part IV-2 ≥ 2 at screening.
. Subject who is on treatment with levodopa formulation at least 3 times daily at screening.
Exclusion criteria
. Subject with a clinically significant history of cardiovascular, hepatic, renal, endocrine, gastrointestinal, hematological, respiratory, or neurologic disease other than Parkinson's disease, determined by the investigator.
. Subject who has a disorder or history of a condition that may interfere with drug metabolism or excretion including clinically significant abnormality of the hepatic or renal systems.
. Subject with a history of epilepsy, convulsions, unexplained syncope or other unexplained loss of consciousness (except a single incident), or head trauma with loss of consciousness lasting more than 5 minutes.
. Subject with a clinically significant abnormal 12-lead ECG or a screening 12-lead ECG for safety assessment that demonstrates any one of the following: