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Neurokinin Antagonist

Tradipitant Low Dose for Motion Sickness

Phase 3
Recruiting
Research Sponsored by Vanda Pharmaceuticals
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 1 day
Awards & highlights

Study Summary

"This trial will study the effectiveness of tradipitant in reducing motion sickness in travelers. It will be a blinded study conducted at multiple centers."

Who is the study for?
This trial is for people aged 18-75 who often get motion sickness when traveling. It's not suitable for those with a BMI over 40, other nausea-causing conditions, or past bad reactions to Neurokinin-1 Receptor blockers.Check my eligibility
What is being tested?
The study tests Tradipitant against a placebo to see if it helps prevent travel-related motion sickness. Participants are randomly assigned to either the drug or placebo group without knowing which one they're getting.See study design
What are the potential side effects?
Tradipitant may cause side effects like headache, drowsiness, dry mouth, and in rare cases allergic reactions. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevention of vomiting measured by Vomiting Assessment (VA)

Side effects data

From 2021 Phase 1 & 2 trial • 27 Patients • NCT04849559
15%
fatigue
15%
somnolence
8%
diarrhea
8%
restless leg syndrome
8%
depressed mood
8%
peripheral swelling
8%
disturbance in attention
8%
libido decreased
8%
Acne
8%
dizziness postural
8%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tradipitant
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tradipitant Low DoseExperimental Treatment1 Intervention
Group II: Tradipitant High DoseExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Oral Capsule
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tradipitant
2016
Completed Phase 3
~1180

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
61 Previous Clinical Trials
19,104 Total Patients Enrolled
3 Trials studying Motion Sickness
1,015 Patients Enrolled for Motion Sickness

Frequently Asked Questions

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

Which individuals meet the eligibility criteria for enrollment in this research study?

"Individuals experiencing motion sickness between the ages of 18 and 75 are eligible to participate in this trial, which aims to enroll approximately 300 participants."

Answered by AI

Are individuals still eligible to apply for participation in this ongoing trial?

"Yes, data on clinicaltrials.gov indicates that this research is actively seeking volunteers. The trial was initially listed on 6/1/2023 and last modified on 6/5/2023. Enrollment targets 300 participants from a single site."

Answered by AI

What is the overall count of individuals involved in this research endeavor?

"Affirmative. As per the information available on clinicaltrials.gov, this trial is actively seeking participants. Its initial posting was on June 1st, 2023, and the most recent update occurred on June 5th, 2023. The study plans to enroll a total of 300 individuals at one designated site."

Answered by AI

Can adolescents under the age of 18 participate in this research project?

"Individuals aged 18 to 75 are eligible for enrollment according to the study's inclusion criteria."

Answered by AI

What is the safety profile of Tradipitant in individuals?

"Our team rates the safety of Tradipitant as a 3 on our scale, given that this phase 3 trial has some evidence supporting its efficacy and numerous rounds of data confirming its safety profile."

Answered by AI
~171 spots leftby May 2025