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Neurokinin-1 Receptor Antagonist

Tradipitant 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

Age 18-75

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 1 year

Awards & highlights

Study Summary

This trial studies if a drug called tradipitant can safely reduce symptoms of motion sickness for travelers.

Who is the study for?

This trial is for adults aged 18-75 who have a history of getting motion sickness. It's not suitable for individuals with other nausea-causing conditions, those with a BMI over 40, or anyone allergic to Neurokinin-1 Receptor antagonists.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of Tradipitant in preventing or reducing symptoms of motion sickness during travel. This open label trial allows all participants to receive the medication.See study design

What are the potential side effects?

Potential side effects may include drowsiness, dry mouth, headache, and possible gastrointestinal issues like constipation. Since it's an open label study, more side effects might be identified as participants report them.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety and tolerability of tradipitant as measured by reporting of adverse events (AEs).

Side effects data

From 2021 Phase 1 & 2 trial • 27 Patients • NCT04849559

15%

fatigue

15%

somnolence

peripheral swelling

diarrhea

disturbance in attention

restless leg syndrome

depressed mood

libido decreased

Acne

dizziness postural

headache

100%

80%

60%

40%

20%

Study treatment Arm

Tradipitant

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Group I: Tradipitant Dose BExperimental Treatment1 Intervention

"See Drug"

Group II: Tradipitant Dose AExperimental Treatment1 Intervention

"See Drug"

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tradipitant

2016

Completed Phase 3

~1180

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor

61 Previous Clinical Trials

18,904 Total Patients Enrolled

3 Trials studying Motion Sickness

815 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.

Am I eligible to become a subject in this research experiment?

"This medical trial has set an age limit of 18-75 years old and requires applicants to have signs of motion sickness in order to be considered. Approximately 300 participants are sought after altogether."

Answered by AI

May seniors aged 80 and above participate in this investigation?

"The requirements for enrollment in this medical trial only permit those aged between 18 and 75. There are 1 studies specifically tailored to younger than 18 years old, as well as 5 additional study options open to persons over 65."

Answered by AI

What is the current number of participants in this clinical trial?

"Affirmative, the information on clinicaltrials.gov states that this medical study is actively enrolling patients. It was first published on February 27th 2023 and recently revised on November 13th 2023; 300 participants are anticipated to join from 1 site."

Answered by AI

Has the FDA sanctioned Tradipitant Dose A for public use?

"The safety of tradipitant dose A is rated a 3 on our internal scale, due to the multiple rounds of efficacy data and prior clinical evidence in support."

Answered by AI

Are any more participants being accepted for this clinical trial currently?

"Affirmative. According to information made available on clinicaltrials.gov, this research project is actively seeking volunteers and was first posted in February 27th 2023. It needs about 300 individuals from a single centre for the trial's completion. The most recent update occurred on November 13th of that same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness

2023. "Motion Delos: An Open Label Safety and Efficacy of Tradipitant in Participants Affected by Motion Sickness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06138613.

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