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

500 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

Eligibility Criteria

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

I am between 18 and 75 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Tradipitant in the Treatment of Motion Sickness: A Randomized, Double-Blind, Placebo-Controlled Study. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Comparative in-flight study of a scopolamine-containing membrane plaster versus dimenhydrinate under defined acceleration conditions]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Transdermal therapeutic system scopolamine (TTSS), dimenhydrinate, and placebo--a comparative study at sea. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Transdermal scopolamine in motion sickness. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of transdermally administered scopolamine in preventing motion sickness. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Transdermally administered scopolamine vs. dimenhydrinate. I. Effect on nausea and vertigo in experimentally induced motion sickness. [2019]