Tradipitant for Motion Sickness

Overseen By Dan Norman

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vanda Pharmaceuticals

Disqualifiers: Nausea-inducing disorder, BMI > 40, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called tradipitant for individuals who experience motion sickness during travel. The goal is to determine the safety and effectiveness of tradipitant in reducing symptoms such as nausea and dizziness. Two different doses are being tested to identify which is most effective. Those who have experienced motion sickness in the past, with no other cause for nausea, might find this trial suitable. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to help bring a new treatment closer to availability.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that tradipitant might help prevent vomiting and treat nausea from motion sickness. Ensuring its safety for people is important. Some studies have tested two doses of tradipitant, 85 mg and 170 mg, focusing on its effects during travel, such as in cars or on boats.

While some research is ongoing, the FDA has placed a partial hold on the drug due to safety concerns that need addressing. This does not mean the drug is unsafe, but more information is needed to confirm its safety for motion sickness.

For those considering joining a trial, these studies aim to find both the benefits and any side effects of the treatment. Participating in a trial contributes to important research that could help answer these safety questions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for motion sickness?

Researchers are excited about Tradipitant for motion sickness because it offers a new approach compared to traditional treatments like antihistamines and scopolamine. Most current treatments work by blocking histamine or acetylcholine receptors, often causing drowsiness or dry mouth. Tradipitant, on the other hand, targets the neurokinin-1 (NK1) receptors, potentially reducing symptoms without these side effects. This different mechanism of action not only provides an alternative for those who can't tolerate standard treatments but also holds promise for more effective relief.

What evidence suggests that tradipitant might be an effective treatment for motion sickness?

Research has shown that tradipitant effectively treats motion sickness. Studies found that people taking tradipitant vomited less than those who took a placebo, a pill with no active medicine. Other research also supports that tradipitant helps prevent nausea and vomiting during travel. In this trial, participants will receive either a low dose (Dose A) or a high dose (Dose B) of tradipitant, both of which have effectively reduced symptoms of motion sickness. Overall, tradipitant appears to be a promising option for managing motion sickness. ^{1 4 6 7 8}

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?

Group I: Tradipitant Dose B Experimental Treatment 1 Intervention

"See Drug"

Group II: Tradipitant Dose A Experimental Treatment 1 Intervention

"See Drug"

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials

68

Recruited

19,900+

Published Research Related to This Trial

Transdermal scopolamine significantly reduces motion-induced nausea, achieving a motion sickness incidence of only 16% in a study of 35 susceptible subjects, compared to 32% with oral dimenhydrinate and 59% with placebo.

The transdermal system provides sustained relief for up to 72 hours, offering advantages over oral or intramuscular administration, especially during gastrointestinal distress, and resulting in a 73% protection rate against motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transdermally administered scopolamine in preventing motion sickness. McCauley, ME., Royal, JW., Shaw, JE., et al.[2018]

The transdermal therapeutic system (TTS) for scopolamine provides a constant rate of drug delivery, which helps maintain stable blood levels and reduces the side effects associated with oral dosing.

This new delivery method improves patient compliance and acceptability by allowing for prolonged administration without the need for frequent dosing, making it a safer option for treating motion sickness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal scopolamine in motion sickness. Cronin, CM., Sallan, SE., Wolfe, L.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study. Polymeropoulos, VM., Czeisler, MÉ., Gibson, MM., et al.[2023]

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%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal therapeutic system scopolamine (TTSS), dimenhydrinate, and placebo--a comparative study at sea. Noy, S., Shapira, S., Zilbiger, A., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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]

Transdermal scopolamine (TTS-scopolamine) and dimenhydrinate were both effective in reducing nausea and vertigo caused by motion sickness in a study of 16 healthy volunteers, with scopolamine showing adequate absorption in all subjects.

Dimenhydrinate was slightly more effective against nausea than one patch of TTS-scopolamine, but both treatments had minimal side effects, although two patches of scopolamine could occasionally cause gait disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermally administered scopolamine vs. dimenhydrinate. I. Effect on nausea and vertigo in experimentally induced motion sickness. Pyykkö, I., Schalén, L., Jäntti, V.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40103934/

tradipitant effective in the treatment of motion sickness; a ... Results: The incidence of vomiting in both dosing arms of tradipitant was significantly lower than the placebo group across all boat trips ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03772340?term=motion%20sickness&viewType=Table&rank=8

Motion Sifnos: A Study to Investigate the Efficacy of ... Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness . Official Title. Motion Sifnos: A ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1542356524000508

The Efficacy of Tradipitant in Patients With Diabetic and ... Tradipitant also has shown efficacy in nausea and vomiting prevention in motion sickness. ... Results from a controlled trial with the nk1 antagonist aprepitant.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7550735/

Tradipitant in the Treatment of Motion Sickness Tradipitant has the potential to be an effective therapy for the prevention of vomiting and treatment of nausea in people with motion sickness.

5. vandapharmaceuticalsinc.gcs-web.com vandapharmaceuticalsinc.gcs-web.com/node/15956/pdf

Vanda Pharmaceuticals Reports Positive Results from a ... Tradipitant (170 mg and 85 mg together) was also effective in the endpoint of prevention of severe nausea and vomiting (tradipitant 13.3%, ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/61/NCT04327661/Prot_SAP_000.pdf

VP-VLY-686-3401 Amendment 2 Vanda Pharmaceuticals ... To assess the effects of tradipitant 85 mg and 170 mg on the prevention of vomiting from motion sickness during vehicle travel as measured by ...

7. vandapharmaceuticalsinc.gcs-web.com vandapharmaceuticalsinc.gcs-web.com/node/14786/pdf

Vanda Pharmaceuticals Reports Results from the Phase III ... Tradipitant is currently in clinical development for gastroparesis and motion sickness. The FDA has imposed a partial clinical hold on ...

8. prnewswire.com prnewswire.com/news-releases/vanda-pharmaceuticals-reports-results-from-the-phase-iii-study-of-tradipitant-in-gastroparesis-301475597.html

Vanda Pharmaceuticals Reports Results from the Phase III ... Tradipitant is currently in clinical development for gastroparesis and motion sickness. The FDA has imposed a partial clinical hold on ...