Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease

NCT05766813 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 132 participants
Start Date 2023-03-13
Est. Completion 2025-10
Phase Phase 2

Sponsor

Intra-Cellular Therapies

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05766813

The ClinicalTrials.gov registry entry for NCT05766813 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 54 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05766813 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05766813?

The interventions under investigation include: Placebo (DRUG), Lenrispodun (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05766813?

This trial is sponsored by Intra-Cellular Therapies, which has 54 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial