Levodopa-induced dyskinesia in Parkinson's disease
Conditions
Interventions
Subjects receive DSP-9632P 27.5 mg to 123.75 mg or placebo transdermally.
Sponsors
Nakamura Hiroki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject whose age is >= 50 and = 2 and Part IV-2 >= 2 at screening. 8. Subject who is on treatment with levodopa formulation at least 3 times daily at screening. 9. Subject who is able to receive 11C-raclopride PET scans (Part A only). 10. Subject who has a score of >= 2 in any of questions of UDysRS Part 1B at screening (Part B only). 11. Subjects who can wear the glasses-type wearable device and agree to wear it (Part B only). 12. Subject who is able to comply with the study requirements, including physical examination, assessments, and reporting symptoms. 13. Subject who is willing to practice abstinence or use appropriate contraception as part of the subject's lifestyle from signing informed consent through 30 days after the last dose of study drug. 14. Subject who is on treatment with levodopa formulation at least 3 times daily and is treated with levodopa formulation with a fixed dosing regimen for at least 28 days prior to Period 1 (Part A) or prior to admission (Part B). 15. Subject who is in the ON state with dyskinesia every day for at least 30 minutes twice or more daily based on the PD home diary during the placebo lead-in period (Part B only).
Exclusion criteria
Exclusion criteria: 1. 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. 2. 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. 3. 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. 4. 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: Heart rate > 100 bpm or 120 msec QTcF > 450 msec (male) or > 470 msec (female) PR interval > 200 msec 5. Subject with dermatosis or skin abnormality (eg, dermatitis, eczema, or dyschromatosis) at application sites. 6. Subject with a history of drug allergy or skin allergy. 7. Subject with a known sensitivity to any transdermal patch. 8. Subject with a history of drug abuse or narcotic abuse, or a positive urine drug screening at screening. 9. Subject who has a positive immunology at screening. 10. Subject with any clinically significant abnormal clinical laboratory value (hematology test, serum chemistry test, urinalysis, coagulation test, or lipid test) determined by the investigator at screening. 11. Subject with a history of biphasic dyskinesia, myoclonus, or apathy. 12. Subject with a current or history of psychiatric illness (eg, schizophrenia, bipolar disorder, depression) based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). 13. Subject with Mini-Mental State Examination (MMSE) score of == 400 mL) during the 90 days prior to screening or donated 200 mL of blood or more during the 30 days prior to screening; has donated blood components during the 14 days prior to screening or intends to donate blood components or blood during the 30 days after the last study visit. 19. Subject who is in the opinion of the investigator unsuitable in any other way to participate in this study. 20. Subject who has a positive urine drug screening at admission. 21. Subject who has consumed caffein or smoked in 2 days prior to the admission or has consumed alcohol in 1 day prior to the admission (Part A only). 22. Subject who answers "yes" to "Suicidal Ideation" Items 4 or 5 on the C-SSRS at admission. 23. Subject who has used dopamine receptor antagonists (antipsychotics, metoclopramide, domperidone) within 14 days prior to Period 1. 24. Subject who has used serotonergic 5-HT1A/1B agonists/antagonists (tandospirone, sumatriptan, zolmitriptan, eletriptan, rizatriptan, naratriptan, Yokukansan) during the 14 days prior to Period 1. 25. Subject who has used therapeutic agents (monoamine oxidase B [MAO-B] inhibitors,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic endpoints: Binding potential of 11C-raclopride to dopamine D2 receptors, Dopamine D2 receptor occupancy rate of dopamine derived from levodopa Safety endpoints: Adverse events, Clinical Laboratory tests, Vital signs, 12-lead electrocardiogram, Columbia Suicide Severity Rating Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoints: UDysRS score, MDS-UPDRS score Pharmacokinetics endpoints: Plasma PK of levodopa, Plasma concentrations of tandospirone and 1-PP | — |
Contacts
Public ContactProduct information center
Sumitomo Pharma Co., Ltd.
Outcome results
None listed