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This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in patients with a diagnosis of Parkinson's Disease consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria, who are experiencing wearing off symptoms and levodopa-induced dyskinesia.
The study will be conducted in three periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenrispodun 30 mg | Experimental | Lenrispodun 30 mg tablets administered orally, once-daily. |
|
| Placebo | Placebo Comparator | Matching tablets administered orally, once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenrispodun | Drug | Lenrispodun 30 mg tablets administered orally, once daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hauser Diary | The Hauser Diary is a validated and commonly used patient-self-report home diary to assess motor symptoms in PD. It asks patients to characterize their predominant motor states in 30-minute intervals as Asleep, OFF, ON without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | The MDS-UPDRS evaluates various aspects of Parkinson's disease and has four parts: Part I (Non-motor Aspects of Experiences of Daily Living), Part II (Motor Aspects of Experiences of Daily Living), Part III (Motor Examination), and Part IV (Motor Complications). The MDS-UPDRS evaluates various aspects of Parkinson's disease and has four parts: Part I (Non-motor Aspects of Experiences of Daily Living), Part II (Motor Aspects of Experiences of Daily Living), Part III (Motor Examination), and Part IV (Motor Complications). Each parkinsonian sign or symptom on the MDS-UPDRS is rated on a 5-point scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD. |
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Inclusion Criteria:
Male or female between 40 years of age and older
Body mass index of 19.0-40.0 kg/m2;
Diagnosis of PD that is consistent with the UK Parkinson's Disease Society (UKPDS) Brain Bank diagnostic criteria;
Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state;
Have a clinically meaningful response to levodopa (levodopa + DDCI combination) based on Investigator assessment, and meet the following:
7. Have wearing-off symptoms and levodopa-induced dyskinesia as per Investigator judgment; 8. Properly complete and return a self-reported home diary for motor function status (Hauser Diary) during the Screening Period, which confirms 3 days (ie, 3 consecutive, 24-hour periods) immediately prior to Baseline, each with at least 2½ hours of OFF time during waking hours.
9. Has a caregiver to assist with study participation, if determined by the Investigator to be necessary.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Phoenix | Arizona | 85013 | United States | ||
| Clinical Site |
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| Placebo |
| Drug |
Matching tablets administered orally, once daily. |
|
| Day 29 |
| Scottsdale |
| Arizona |
| 85251 |
| United States |
| Clinical Site | Irvine | California | 92697 | United States |
| Clinical Site | Loma Linda | California | 92354 | United States |
| Clinical Site | Altamonte Springs | Florida | 32714 | United States |
| Clinical Site | Boca Raton | Florida | 33486 | United States |
| Clinical Site | Coral Springs | Florida | 33067 | United States |
| Clinical Site | Doral | Florida | 33178 | United States |
| Clinical Site | Hallandale | Florida | 33009 | United States |
| Clinical Site | Maitland | Florida | 32751 | United States |
| Clinical Site | Miami | Florida | 33136 | United States |
| Clinical Site | Ocala | Florida | 34470 | United States |
| Clinical Site | Orlando | Florida | 32804 | United States |
| Clinical Site | Orlando | Florida | 32825 | United States |
| Clinical Site | Port Orange | Florida | 32127 | United States |
| Clinical Site | Tampa | Florida | 33612 | United States |
| Clinical Site | Augusta | Georgia | 30912 | United States |
| Clinical Site | Decatur | Georgia | 30030 | United States |
| Clinical Site | Kansas City | Kansas | 66160 | United States |
| Clinical Site | Farmington Hills | Michigan | 48334 | United States |
| Clinical Site | Golden Valley | Minnesota | 55427 | United States |
| Clinical Site | Albany | New York | 12208 | United States |
| Clinical Site | Rock Hill | South Carolina | 29732 | United States |
| Clinical Site | Franklin | Tennessee | 37067 | United States |
| Clinical Site | Memphis | Tennessee | 38157 | United States |
| Clinical Site | Austin | Texas | 78746 | United States |
| Clinical Site | Dallas | Texas | 75243 | United States |
| Clinical Site | Georgetown | Texas | 78628 | United States |
| Clinical Site | Alexandria | Virginia | 22311 | United States |
| Clinical Site | Falls Church | Virginia | 22042 | United States |
| Clinical Site | Henrico | Virginia | 23233 | United States |
| Clinical Site | Kirkland | Washington | 98034 | United States |
| Clinical Site | Spokane | Washington | 99202 | United States |
| Clinical Site | Crab Orchard | West Virginia | 25827 | United States |
| Clinical Site | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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