Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Intra-Cellular Therapies, Inc.
- Study ID
- NCT05766813
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lenrispodun — DRUGLenrispodun 30 mg tablets administered orally, once daily.
- Placebo — DRUGMatching tablets administered orally, once daily.
Study Details
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.
Key Dates
- First listed
- Mar 13, 2023
- Start date
- Mar 13, 2023
- Status verified
- May 2026
- Primary completion
- Oct 28, 2025
- Completion
- Nov 4, 2025
Study Design
- Enrollment
- 79 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Lenrispodun 30 mgLenrispodun 30 mg tablets administered orally, once-daily.
- Placebo Comparator: PlaceboMatching tablets administered orally, once daily.
Primary Outcome Measure
Hauser Diary [ Time Frame: Day 29 ]
Locations (35)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical Site | Phoenix | Arizona | 85013 | - |
| Clinical Site | Scottsdale | Arizona | 85251 | - |
| Clinical Site | Irvine | California | 92697 | - |
| Clinical Site | Loma Linda | California | 92354 | - |
| Clinical Site | Altamonte Springs | Florida | 32714 | - |
| Clinical Site | Boca Raton | Florida | 33486 | - |
| Clinical Site | Coral Springs | Florida | 33067 | - |
| Clinical Site | Doral | Florida | 33178 | - |
| Clinical Site | Hallandale | Florida | 33009 | - |
| Clinical Site | Maitland | Florida | 32751 | - |
| Clinical Site | Miami | Florida | 33136 | - |
| Clinical Site | Ocala | Florida | 34470 | - |
| Clinical Site | Orlando | Florida | 32804 | - |
| Clinical Site | Orlando | Florida | 32825 | - |
| Clinical Site | Port Orange | Florida | 32127 | - |
| Clinical Site | Tampa | Florida | 33612 | - |
| Clinical Site | Augusta | Georgia | 30912 | - |
| Clinical Site | Decatur | Georgia | 30030 | - |
| Clinical Site | Kansas City | Kansas | 66160 | - |
| Clinical Site | Farmington Hills | Michigan | 48334 | - |
| Clinical Site | Golden Valley | Minnesota | 55427 | - |
| Clinical Site | Albany | New York | 12208 | - |
| Clinical Site | Rock Hill | South Carolina | 29732 | - |
| Clinical Site | Franklin | Tennessee | 37067 | - |
| Clinical Site | Memphis | Tennessee | 38157 | - |
| Clinical Site | Austin | Texas | 78746 | - |
| Clinical Site | Dallas | Texas | 75243 | - |
| Clinical Site | Georgetown | Texas | 78628 | - |
| Clinical Site | Alexandria | Virginia | 22311 | - |
| Clinical Site | Falls Church | Virginia | 22042 | - |
| Clinical Site | Henrico | Virginia | 23233 | - |
| Clinical Site | Kirkland | Washington | 98034 | - |
| Clinical Site | Spokane | Washington | 99202 | - |
| Clinical Site | Crab Orchard | West Virginia | 25827 | - |
| Clinical Site | Milwaukee | Wisconsin | 53226 | - |
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