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Lenrispodun for Parkinson's Disease

Verified Trial
Phase 2
Recruiting
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between 40 and 80 years of age, inclusive
Hoehn and Yahr Scale stage classification of 2 or 3 when in the ON state
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 29
Awards & highlights

Study Summary

This trial tests a new Parkinson's treatment in patients with wearing off symptoms and dyskinesia.

Who is the study for?
This trial is for adults aged 40-80 with Parkinson's Disease, experiencing motor fluctuations and levodopa-induced dyskinesia. They must respond well to levodopa treatment, have a stable medication regimen, and be able to track their motor function. Excluded are those with other forms of parkinsonism, severe PD symptoms or dementia, and users of certain drugs like MAO-A inhibitors.Check my eligibility
What is being tested?
The study tests Lenrispodun against a placebo in managing Parkinson's symptoms. Participants will be randomly assigned to receive either the drug or placebo alongside their regular medications in a controlled environment across multiple centers.See study design
What are the potential side effects?
While specific side effects for Lenrispodun aren't listed here, similar trials may include risks such as nausea, dizziness, sleep disturbances or worsening of some Parkinson's symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 80 years old.
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My Parkinson's is moderate, and I can move with little to some help.
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I have been on a stable dose of levodopa for Parkinson's for at least 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hauser Diary
Secondary outcome measures
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lenrispodun 30 mgExperimental Treatment1 Intervention
Lenrispodun 30 mg tablets administered orally, once-daily.
Group II: PlaceboPlacebo Group1 Intervention
Matching tablets administered orally, once daily.

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
30 Previous Clinical Trials
7,399 Total Patients Enrolled

Media Library

Lenrispodun 30 mg Clinical Trial Eligibility Overview. Trial Name: NCT05766813 — Phase 2
Parkinson's Disease Research Study Groups: Lenrispodun 30 mg, Placebo
Parkinson's Disease Clinical Trial 2023: Lenrispodun 30 mg Highlights & Side Effects. Trial Name: NCT05766813 — Phase 2
Lenrispodun 30 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766813 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants over the age of 35?

"Patients aged 40-80 are being recruited for this clinical trial."

Answered by AI

What criteria must be met in order to participate in this medical experiment?

"This research trial is seeking 132 individuals who have been clinically diagnosed with parkinson's disease and are between 40-80 years old."

Answered by AI

How might Lenrispodun 30 mg be a hazard to human health?

"A score of 2 has been assigned to Lenrispodun 30 mg due to the Phase 2 trial's lack of efficacy data, though there is enough evidence available for us to draw conclusions regarding its safety."

Answered by AI

How many participants has this trial recruited thus far?

"Affirmative. The clinicaltrials.gov portal states that this medical research, which was initially published on March 1st 2023, is actively seeking participants. 132 individuals are required for the trial to be conducted at two different sites."

Answered by AI

Is this clinical trial actively recruiting participants?

"Affirmative. According to the clinicaltrials.gov portal, this experiment is actively seeking out participants since its initial posting on March 1st 2023 and most recently updated on 10th of March in the same year. 132 study subjects are required from two separate medical sites."

Answered by AI

Who else is applying?

What site did they apply to?
Clinical Site
Other
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Looking to improve my quality of life.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease
2023. "Lenrispodun as Adjunctive Therapy in the Treatment of Patients With Motor Fluctuations Due to Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05766813.
All > Spokane
~54 spots leftby Feb 2025
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