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NCT05766813 · ClinicalTrials.gov registry record · Phase 2
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
A Phase 2 study of Parkinson Disease, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 132
- Enrollment target
- 20
- Study locations
NCT05766813: Recruiting Phase 2 study of Parkinson Disease, sponsored by Intra-Cellular Therapies.
NCT05766813 is a Phase 2 study of Parkinson Disease that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 132 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05766813, a Phase 2 study of Parkinson Disease, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 132 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lenrispodun
Study Locations (20)
Florida
- Clinical Site - Altamonte Springs
- Clinical Site - Boca Raton
- Clinical Site - Coral Springs
- Clinical Site - Hallandale
- Clinical Site - Maitland
- Clinical Site - Miami
- Clinical Site - Ocala
- Clinical Site - Orlando
- Clinical Site - Orlando
- Clinical Site - Port Orange
- Clinical Site - Tampa
Arizona
- Clinical Site - Phoenix
- Clinical Site - Scottsdale
California
- Clinical Site - Irvine
- Clinical Site - Loma Linda
Georgia
- Clinical Site - Augusta
- Clinical Site - Decatur
Kansas
- Clinical Site - Kansas City
Michigan
- Clinical Site - Farmington Hills
Minnesota
- Clinical Site - Golden Valley
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2023-03-13 |
| Est. Completion | 2025-10 |
| Phase | Phase 2 |
What NCT05766813 shows while recruiting
NCT05766813 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05766813 names 20 study sites across 7 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05766813 about?
NCT05766813 is a clinical study titled "Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease". 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-...
What is the current status of trial NCT05766813?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 132 participants. The study started on 2023-03-13. Estimated completion is 2025-10.
What conditions does trial NCT05766813 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT05766813?
The interventions under investigation include: Placebo (DRUG), Lenrispodun (DRUG).
Who is sponsoring clinical trial NCT05766813?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05766813 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinson Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05766813's enrollment target sits among peer trials
132 62nd of 297 higher than 235 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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