← Back to Search

5-HT3R antagonist

Ondansetron 16 mg with Tariquidar for Neuropathic Pain

Phase 1 & 2

Waitlist Available

Led By Simon Haroutounian, PhD

Research Sponsored by Washington University School of Medicine

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 up to 8 weeks following consent

Awards & highlights

Study Summary

This trial will test whether the combination of ondansetron and tariquidar is safe and tolerated by patients with neuropathic pain, and if it improves pain symptoms.

Eligible Conditions

Neuropathic Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks following consent

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks following consent

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks following consent for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Cerebrospinal Fluid Penetration of Ondansetron - Area Under the Curve (AUC)

Cerebrospinal Fluid to Plasma Concentration Ratio of Ondansetron

Plasma Exchange

Secondary outcome measures

Change in Neuropathic Pain Symptom Score

Change in Pain Intensity

Conditioned Pain Modulation (CPM) Magnitude (ΔCPM)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ondansetron + TariquidarExperimental Treatment1 Intervention

Group II: Ondansetron + PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tariquidar

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,850 Total Patients Enrolled

2 Trials studying Neuropathic Pain

14 Patients Enrolled for Neuropathic Pain

Simon Haroutounian, PhDPrincipal InvestigatorWashington University School of Medicine

12 Previous Clinical Trials

3,761 Total Patients Enrolled

1 Trials studying Neuropathic Pain

14 Patients Enrolled for Neuropathic Pain

Media Library

Ondansetron (5-HT3R antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04603066 — Phase 1 & 2

Neuropathic Pain Research Study Groups: Ondansetron + Tariquidar, Ondansetron + Placebo

Neuropathic Pain Clinical Trial 2023: Ondansetron Highlights & Side Effects. Trial Name: NCT04603066 — Phase 1 & 2

Ondansetron (5-HT3R antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04603066 — Phase 1 & 2

Frequently Asked Questions

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

Is this experiment open to elderly enrollees or confined to a younger cohort?

"This clinical research is accepting volunteers aged 18-65."

Answered by AI

What conditions is the Ondansetron 16 mg with Tariquidar combination typically employed to ameliorate?

"Ondansetron 16 mg with Tariquidar is traditionally used to treat uremia, but can also be prescribed as an antidote for radiation therapy induced nausea and vomiting, pharmacotherapy-induced side effects, and pruritus."

Answered by AI

What aims is this study hoping to achieve?

"The primary endpoint of the trial, which is to be measured over an 8 week period post-consent, involves exploring the Cerebrospinal Fluid to Plasma Concentration Ratio of Ondansetron. Secondary goals are quantifying Correlation between CPM Magnitude (ΔCPM) and Change in Pain Intensity through bivariate regression; determining Conditioned Pain Modulation (CPM) Magnitude (ΔCPM); and observing Changes in Pain Intensity from baseline to 60-120 minutes after ondansetron IV infusion with or without tariquidar administration."

Answered by AI

Is the enrollment period for this trial still accessible?

"Indeed, according to information provided on clinicaltrials.gov, this experiment is currently enrolling participants; it was first advertised on the 31st of January 2021 and was last amended on September 23rd 2021. An enrollment goal of 32 patients across one site has been set for this trial."

Answered by AI

How many enrollees is the clinical trial accepting at this point in time?

"Affirmative, according to clinicaltrials.gov, this research project is still open for recruitment and recently updated on September 23rd 2021. As of now, 32 volunteers are needed at a single location."

Answered by AI

Who is eligible to take part in this clinical trial?

"This research endeavour is searching for 32 eligible individuals between the ages of 18 and 65 who suffer from neuralgia. To be considered, applicants must meet all of the following: Be aged 18-65; Have a proven diagnosis of neuropathic pain caused by damage or illness that impacts their peripheral nervous system; Possess at least Probable neuropathic pain grading 1; Live with this condition for more than 3 months on average; Experience an intensity level no lower than 4 out of 10 in terms of numerical rating scale (NRS)."

Answered by AI