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Serotonin Inverse Agonist/Antagonist

Pimavanserin for Chronic Insomnia

Phase 4
Waitlist Available
Led By Melissa B Jones, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing whether a drug called pimavanserin can help Veterans with insomnia and PTSD.

Eligible Conditions
  • Chronic Insomnia
  • Post-Traumatic Stress Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recruitment rates
Retention rates
Secondary outcome measures
Completion rates of key outcome measures
Discontinuation rates due to adverse effects
Mean change in duration of stage N3 sleep pre- and post-treatment

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%
0%
Study treatment Arm
Open-label Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: open-label pimavanserin 34mg at bedtime for 6 weeksExperimental Treatment1 Intervention
Subjects enrolled into treatment with open-label, fixed-dose pimavanserin 34mg at bedtime for 6 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pimavanserin
2018
Completed Phase 4
~3010

Find a Location

Who is running the clinical trial?

ACADIA Pharmaceuticals Inc.Industry Sponsor
46 Previous Clinical Trials
10,940 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,180 Total Patients Enrolled
Melissa B Jones, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
66 Total Patients Enrolled

Frequently Asked Questions

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

How many people have enrolled in this clinical experiment?

"This trial is no longer seeking participants. It was first made available to the public on December 15th 2022 and has not been updated since June 14th 2022. If you are looking for other studies regarding post traumatic stress disorder (ptsd), there are currently 1,420 active clinical trials; additionally, 6 unique medical investigations related to Pimavanserin remain open for enrollment."

Answered by AI

To what extent does Pimavanserin risk patient safety?

"Backed by the approval of Phase 4 trials, Pimavanserin's safety is rated a 3 on our internal scale."

Answered by AI

Is Pimavanserin being explored for any other medicinal purposes?

"Currently, there are 6 ongoing clinical trials for Pimavanserin; with 3 of them in the late-phase. Although Houston, Texas is where many studies on this drug have been based from, it's being administered at 414 different medical locations worldwide."

Answered by AI

Does this research endeavor have any precedents?

"Research into the effects of pimavanserin began in 2017, when ACADIA Pharmaceuticals Inc. sponsored its first clinical trial. This 500-person study proved successful, leading to Phase 3 approval for the drug at a later date. To this day, 6 international studies involving 101 cities and 20 countries are currently ongoing concerning Pimavanserin's efficacy."

Answered by AI

Are potential participants still invited to join this research endeavor?

"At this juncture, the trial listed on clinicaltrials.gov is not recruiting patients; it was first posted in December 15th 2022 and last amended on June 14th 2021. Nevertheless, there are presently 1,426 investigations that could use volunteers."

Answered by AI

Who meets the eligibility requirements to partake in this experiment?

"To qualify for this clinical trial, patients must have a diagnosis of PTSD and be aged between 18 and 64. This medical experiment is looking to recruit 20 individuals in total."

Answered by AI

Does the study accept participants above a certain age?

"According to the inclusion criteria, patients aged between 18 and 64 are eligible for this medical study. In contrast, there are 304 studies exclusively targeting individuals below the age of consent and another 1,010 pertaining to those above 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Tennessee
South Carolina
How old are they?
18 - 65
What site did they apply to?
Michael E. DeBakey VA Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~0 spots leftby Apr 2025