What side effects are associated with this type of intervention?

Common treatments for motion sickness include antihistamines (such as dimenhydrinate and cinnarizine) and anticholinergics (such as scopolamine). The known side effects of these treatments can include drowsiness, dry mouth, blurred vision, and dizziness. For NK1 receptor antagonists like Tradipitant, which are being studied for motion sickness, potential side effects may include nausea, headache, and fatigue, although specific data on Tradipitant's side effects in motion sickness are not detailed.

What prior FDA approvals exist?

The FDA has approved several treatments for motion sickness, including antihistamines like dimenhydrinate and meclizine, and anticholinergics like scopolamine. While these are the traditional treatments, there is limited information on FDA-approved NK1 receptor antagonists specifically for motion sickness. Tradipitant, an NK1 receptor antagonist, is currently being studied for its efficacy in treating motion sickness, indicating a potential new class of treatment pending further research and approval.

What other types of research exist?

Promising novel alternatives to Tradipitant for motion sickness treatment in 2024 include: 1. Scopolamine patches, which are well-established but continue to be refined for better efficacy and fewer side effects. 2. Newer antihistamines like Meclizine and Dimenhydrinate, which are being optimized for better tolerability. 3. Non-pharmacological approaches such as transcutaneous electrical nerve stimulation (TENS) and acupressure bands, which have shown potential in recent studies for reducing symptoms without medication-related side effects.

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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

Must not have

Nausea-inducing disorder other than motion sickness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, approximately 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a medication called tradipitant to see if it can help people who get sick when they travel. The study includes both men and women who experience motion sickness. Tradipitant works by stopping the brain from sending signals that cause nausea and vomiting. Tradipitant has the potential to be an effective therapy for the prevention of vomiting and treatment of nausea in people with motion sickness.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a condition that causes nausea, not including motion sickness.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Side effects data

From 2023 Phase 3 trial • 366 Patients • NCT04327661

Somnolence

Headache

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Tradipitant Low Dose

Placebo

Tradipitant High Dose

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

2021

Completed Phase 3

~1410

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Tradipitant, an NK1 receptor antagonist, works by blocking the action of substance P, a neuropeptide involved in vomiting and nausea pathways. Common treatments for motion sickness include antihistamines (e.g., dimenhydrinate) that block H1 receptors to reduce vestibular system activity, and anticholinergics (e.g., scopolamine) that inhibit muscarinic receptors to prevent nausea signals from reaching the brain. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment based on their specific symptoms and potential side effects, ensuring better management of motion sickness.

The importance of systematic approaches in the study of emesis.