New drug smooths on periods
- Trial ID
- NCT05766813
- Official Title
- A Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
- Goal
- New drug smooths on periods
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Intra-Cellular Therapies, Inc.
- Study Type
- INTERVENTIONAL
- Enrollment
- 132 participants
- Conditions
- Parkinson Disease
- Interventions
- Lenrispodun, Placebo
Plain-Language Summary
The goal is to lessen OFF time and troublesome levodopa-induced dyskinesia so people with Parkinson's have smoother ON periods. Lenrispodun is an experimental PDE1 inhibitor given in addition to your usual levodopa, it boosts intracellular signaling molecules like cAMP and cGMP to enhance and stabilize dopamine-related signaling rather than just increasing levodopa dose. Participants are adults 40 and older with idiopathic PD, Hoehn and Yahr stage 2 or 3 ON, a clear response to levodopa, wearing-off with at least about 2.5 hours OFF time per day on home diaries, and a stable levodopa regimen (minimum about 100 mg three times daily). People with atypical parkinsonism, advanced unpredictable fluctuations, dementia, or certain interacting medications are not eligible.
Locations
- Clinical Site, Phoenix, Arizona, United States
- Clinical Site, Scottsdale, Arizona, United States
- Clinical Site, Irvine, California, United States
- Clinical Site, Loma Linda, California, United States
- Clinical Site, Altamonte Springs, Florida, United States
- Clinical Site, Boca Raton, Florida, United States
- Clinical Site, Coral Springs, Florida, United States
- Clinical Site, Hallandale, Florida, United States
- Clinical Site, Maitland, Florida, United States
- Clinical Site, Miami, Florida, United States
- Clinical Site, Ocala, Florida, United States
- Clinical Site, Orlando, Florida, United States
- Clinical Site, Orlando, Florida, United States
- Clinical Site, Port Orange, Florida, United States
- Clinical Site, Tampa, Florida, United States
- Clinical Site, Augusta, Georgia, United States
- Clinical Site, Decatur, Georgia, United States
- Clinical Site, Kansas City, Kansas, United States
- Clinical Site, Farmington Hills, Michigan, United States
- Clinical Site, Golden Valley, Minnesota, United States
And 11 more locations.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Lenrispodun. The goal is to lessen OFF time and troublesome levodopa-induced dyskinesia so people with Parkinson's have smoother ON periods. Lenrispodun is an experimental PDE1 inhibitor given in addition to your usual levodopa, it boosts intracellular signaling molecules like cAMP and cGMP to enhance and stabilize dopamine-related signaling rather than just increasing levodopa dose. Participants are adults 40 and older with idiopathic PD, Hoehn and Yahr stage 2 or 3 ON, a clear response to levodopa, wearing-off with at least about 2.5 hours OFF time per day on home diaries, and a stable levodopa regimen (minimum about 100 mg three times daily). People with atypical parkinsonism, advanced unpredictable fluctuations, dementia, or certain interacting medications are not eligible.
- Who can participate?
- Participants must be at least 40 Years.
- Where is this trial located?
- This trial is recruiting at 31 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 2 years and 6 months.