500 Participants Needed

Tradipitant for Motion Sickness

VP
DN
Overseen ByDan Norman
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Vanda Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

How does the drug Tradipitant differ from other treatments for motion sickness?

Tradipitant is unique because it works by blocking NK1 receptors, which are involved in the pathways that cause nausea and vomiting, unlike other treatments that often use scopolamine or dimenhydrinate. This novel mechanism may offer better relief from motion sickness symptoms, especially in rough conditions, with fewer side effects.12345

What data supports the effectiveness of the drug Tradipitant for motion sickness?

In a study, Tradipitant significantly reduced the incidence of vomiting in people experiencing motion sickness on boat trips, especially in rough sea conditions, compared to a placebo. This suggests that Tradipitant may be effective in preventing vomiting and treating nausea caused by motion sickness.12456

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

History of Motion Sickness

Exclusion Criteria

I have a condition that causes nausea, not including motion sickness.
History of intolerance and/or hypersensitivity to Neurokinin-1 Receptor antagonists
BMI > 40

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tradipitant to assess its safety and efficacy in treating motion sickness

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tradipitant
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Tradipitant Dose BExperimental Treatment1 Intervention
"See Drug"
Group II: Tradipitant Dose AExperimental Treatment1 Intervention
"See Drug"

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials
68
Recruited
19,900+

Published Research Related to This Trial

In a study involving 126 adults, the NK1 receptor antagonist tradipitant significantly reduced the incidence of vomiting in participants experiencing motion sickness compared to a placebo, especially in rough sea conditions (tradipitant 15.79% vs. placebo 72.22%).
Tradipitant also led to lower overall motion sickness symptoms, with a mean severity score of 3.19 compared to 4.57 for the placebo group, indicating its potential as an effective treatment for nausea and vomiting associated with motion sickness.
Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study.Polymeropoulos, VM., Czeisler, Mร‰., Gibson, MM., et al.[2023]
In a study involving 20 participants with motion sickness, the transdermal system Scopoderm TTS (scopolamine) was found to be as effective as the oral antiemetic dimenhydrinate during a 1-hour test flight.
Scopoderm TTS offers a significant advantage for long-distance travel, providing effective motion sickness prevention for up to 72 hours, compared to the shorter duration of dimenhydrinate.
[Comparative in-flight study of a scopolamine-containing membrane plaster versus dimenhydrinate under defined acceleration conditions].Offenloch, K., Zahner, G., Dietlein, G., et al.[2018]
In a study involving 140 subjects, transdermal scopolamine was found to be more effective than oral dimenhydrinate in preventing motion sickness at sea, reducing the incidence of motion sickness to 16.66% compared to 22.22% with dimenhydrinate.
Transdermal scopolamine provided 61.67% protection against motion sickness, significantly outperforming the placebo effect, which only reduced incidence to 43.47%.
Transdermal therapeutic system scopolamine (TTSS), dimenhydrinate, and placebo--a comparative study at sea.Noy, S., Shapira, S., Zilbiger, A., et al.[2018]

Citations

Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study. [2023]
[Comparative in-flight study of a scopolamine-containing membrane plaster versus dimenhydrinate under defined acceleration conditions]. [2018]
Transdermal therapeutic system scopolamine (TTSS), dimenhydrinate, and placebo--a comparative study at sea. [2018]
Transdermal scopolamine in motion sickness. [2019]
Effect of transdermally administered scopolamine in preventing motion sickness. [2018]
Transdermally administered scopolamine vs. dimenhydrinate. I. Effect on nausea and vertigo in experimentally induced motion sickness. [2019]
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