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Serotonin Inverse Agonist/Antagonist

Pimavanserin (Nuplazid) for Parkinson's Disease

Q: Are there ongoing efforts to actively enroll participants for this clinical trial?

Affirmative. The details on clinicaltrials.gov indicate that this study is currently seeking participants. Initially posted on April 4th, 2024, and last revised on March 7th, 2024, the trial aims to enroll a total of ten individuals from one location.

Q: What is the total number of individuals participating in this medical investigation?

Yes, the data on clinicaltrials.gov reveals that this investigation is currently in search of suitable candidates. The trial was initially listed on April 4th, 2024 and had its most recent update on March 7th, 2024. Researchers aim to enroll a total of 10 participants at a single site.

Q: Which individuals meet the criteria to be eligible for participation in this research investigation?

Patients aged between 40 and 85 with a confirmed diagnosis of <a href="https://www.withpower.com/clinical-trials/parkinson&#x27;s-disease">Parkinson's disease</a> are eligible for inclusion in this trial, which aims to enroll approximately 10 participants.

Q: Are people who have surpassed the age of 50 years considered suitable candidates for participation in this medical research study?

Potential candidates for this research project must fall within the age range of 40 to 85 years. Notably, there are a total of 21 investigations focused on individuals below 18 years old and an additional 518 studies targeting participants above the age of 65.

Phase < 1

Recruiting

Led By Christian J Amlang, MD

Research Sponsored by State University of New York - Downstate Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial is for patients with Parkinson's Disease who experience symptoms like seeing things that aren't there and having false beliefs, as well as sleep issues.

Who is the study for?

This trial is for Parkinson's Disease patients aged 40-85 with sleep issues and psychosis like hallucinations or delusions. They must have a confirmed diagnosis according to UK standards, stable PD medication doses for the last 30 days, and no other conditions that would exclude them.Check my eligibility

What is being tested?

The study tests Pimavanserin, a drug intended to improve sleep in those with Parkinson's Disease who also experience psychosis. It's a pilot study where participants serve as their own control group to see if the drug makes a difference.See study design

What are the potential side effects?

Pimavanserin may cause side effects such as swelling of the legs, nausea, confusion or even worsening of hallucinations or delusions; however, individual reactions can vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of pimavanserin on sleep fragmentation

Secondary outcome measures

Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder

Effect of pimavanserin on sleep efficiency

Effect of pimavanserin on sleep latency

+5 more

Side effects data

From 2021 Phase 4 trial • 6 Patients • NCT04188392

33%

sleepiness

17%

skin irritation

17%

headache

17%

arthralgia

17%

diarrhea

17%

weight gain

17%

dry mouth

100%

80%

60%

40%

20%

Study treatment Arm

Open-label Treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pimavanserin (Nuplazid)Experimental Treatment1 Intervention

Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks for patients with Parkinson disease psychosis (e.g., visual hallucinations, delusions) and sleep problems

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pimavanserin

2018

Completed Phase 4

~3010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

State University of New York - Downstate Medical CenterLead Sponsor

66 Previous Clinical Trials

12,589 Total Patients Enrolled

ACADIA Pharmaceuticals Inc.Industry Sponsor

46 Previous Clinical Trials

10,930 Total Patients Enrolled

Christian J Amlang, MDPrincipal InvestigatorState University of New York - Downstate Medical Center

Frequently Asked Questions

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

Are there ongoing efforts to actively enroll participants for this clinical trial?

"Affirmative. The details on clinicaltrials.gov indicate that this study is currently seeking participants. Initially posted on April 4th, 2024, and last revised on March 7th, 2024, the trial aims to enroll a total of ten individuals from one location."

Answered by AI

What is the total number of individuals participating in this medical investigation?

"Yes, the data on clinicaltrials.gov reveals that this investigation is currently in search of suitable candidates. The trial was initially listed on April 4th, 2024 and had its most recent update on March 7th, 2024. Researchers aim to enroll a total of 10 participants at a single site."

Answered by AI

Which individuals meet the criteria to be eligible for participation in this research investigation?

"Patients aged between 40 and 85 with a confirmed diagnosis of Parkinson's disease are eligible for inclusion in this trial, which aims to enroll approximately 10 participants."

Answered by AI

Are people who have surpassed the age of 50 years considered suitable candidates for participation in this medical research study?

"Potential candidates for this research project must fall within the age range of 40 to 85 years. Notably, there are a total of 21 investigations focused on individuals below 18 years old and an additional 518 studies targeting participants above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pimavanserin for Sleep in Parkinson Disease

2024. "Pimavanserin for Sleep in Parkinson Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05796167.

All > Sleep > Nuplazid