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CompletedNCT03270839Updated Oct 3, 2025

Motion Sickness Medications and Vestibular Time Constant

A Phase 4 interventional study of Bonine 25Mg Chewable Tablet and Kwells in Drug Reaction, sponsored by Medical Corps, Israel Defense Force. Completed at 1 site in Israel. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Medical Corps, Israel Defense Force · Phase 4, Interventional, and Other

Phase
Phase 4
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study summary

Sea sickness represents a major limitation on the performance of ships' crew. One of the challenges faced by the physician in the motion sickness clinic when prescribing anti-sea sickness medication is to select the appropriate drug for the patient. Difficulties arise due to high variability in the response to different drugs. In the case of sea sickness, the current procedure is to examine the drug's efficacy in each individual during real time exposure to sea conditions.

A number of studies have documented the presence of sea sickness drug receptors in the vestibular nuclei, which determine the vestibular time constant. Two clinical vestibular tests which evaluate the time constant are the Velocity Step and OKAN tests. The purpose of the proposed study is to evaluate the influence of motion sickness drugs on the vestibular time constant, as a possible bioequivalent of drug potency in the individual subject. Eighty crew members will be recruited and divided into groups responsive and non-responsive to the sea sickness drugs scopolamine and meclizine.

Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and no improvement in symptoms after treatment will be defined as non-responsive to sea sickness drugs. Subjects having a Wiker score of 7 in waves 1 meter high without drug treatment, and a Wiker score of 4 or less after treatment, will be defined as responsive to drug therapy.

Kwells, Bonine and placebo, will be assigned to each subject in a random, double-blind fashion. Each group will perform the Velocity Step and OKAN tests before, one and two hours after drug or placebo administration.

02

Conditions studied

  • Drug Reaction
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy soldiers between the ages of 18 to 40, who suffering from sea sickness
  • 48 hours prior to session without any use of medications
  • Soldiers who vomit in waves 1.5 meter high without drugs treatment

Exclusion criteria

Exclusion Criteria:

  • Anamnestic hearing Impairment
  • Ear infection of any kind
  • Pathological finding in an otoneurological examination, witch will be done by a trained neurophysiologist / a physician. In any case of pathological finding, patient will be advised to continue medical assesment.
  • Vision pathologies the interfere with VNG test.
  • Withdrawal of informed consent by the patient of any cause.
04

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    Responsive to Scopolamine (Active)

    Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )

    Drug: Kwells

  • Placebo comparator
    Responsive to Scopolamine (Placebo)

    Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)

    Drug: Placebo Oral Tablet

  • Active comparator
    Non-responsive to Scopolamine (Active)

    Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1\*day )

    Drug: Kwells

  • Placebo comparator
    Non-responsive to Scopolamine (Placebo)

    Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)

    Drug: Placebo Oral Tablet

  • Active comparator
    Responsive to Meclizine (Active)

    Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )

    Drug: Bonine 25Mg Chewable Tablet

  • Placebo comparator
    Responsive to Meclizine (Placebo)

    Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)

    Drug: Placebo Oral Tablet

  • Active comparator
    Non-responsive to Meclizine (Active)

    Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1\*day )

    Drug: Bonine 25Mg Chewable Tablet

  • Placebo comparator
    Non-responsive to Meclizine (Placebo)

    Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)

    Drug: Placebo Oral Tablet

Interventions

  • DrugBonine 25Mg Chewable Tablet

    Motion sickness drug

    Also known as: Meclizine

  • DrugKwells

    Motion sickness drug

    Also known as: Scopolamine

  • DrugPlacebo Oral Tablet

    No active substance in the tablet

    Also known as: Placebo

05

What researchers measure

Primary outcomes

  1. Vestibular Time Constant Change/differential

    One of the parameters measured in step velocity test \[Sec\]

    Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.

  2. Step Velocity Test Gain Change/differential

    One of the parameters measured in step velocity test \[0-1\]

    Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.

  3. Optokinetic After Nystagmus (OKAN) Gain Change/differential

    One of the parameters measured in optokinetic test \[0-1\]

    Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.

  4. Optokinetic After Nystagmus (OKAN) Time Constant Change/differential

    One of the parameters measured in optokinetic test \[Sec\]

    Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.

  5. Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential

    One of the parameters measured in optokinetic test \[Deg/Sec\]

    Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.

  6. Pupil Size Change/differential

    Using pupil size chart \[Mm\]

    Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.

  7. Pupil Accommodation and Convergation Change/differential

    Eye test for drugs side effects.

    Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.

  8. Side Effects Questionnaire Change/differential

    Questionnaire of drugs' side effects.

    Time frame: Baseline at the beginning of session prior to comparator (drug/placebo) receiving, 1 hour after receiving comparator and 2 hours after receiving comparator.

06

Study locations

1 site
  • Israeli Navy Medical Institute
    Haifa, Israel
07

References and documents

Publications

  • Cheung BS, Howard IP, Money KE. Visually-induced sickness in normal and bilaterally labyrinthine-defective subjects. Aviat Space Environ Med. 1991 Jun;62(6):527-31. PubMed 1859339 ↗
  • Dai M, Raphan T, Cohen B. Prolonged reduction of motion sickness sensitivity by visual-vestibular interaction. Exp Brain Res. 2011 May;210(3-4):503-13. doi: 10.1007/s00221-011-2548-8. Epub 2011 Feb 2. PubMed 21287155 ↗
  • Golding JF, Gresty MA. Pathophysiology and treatment of motion sickness. Curr Opin Neurol. 2015 Feb;28(1):83-8. doi: 10.1097/WCO.0000000000000163. PubMed 25502048 ↗
  • Ishiyama A, Lopez I, Wackym PA. Molecular characterization of muscarinic receptors in the human vestibular periphery. Implications for pharmacotherapy. Am J Otol. 1997 Sep;18(5):648-54. PubMed 9303164 ↗
  • Phelan KD, Nakamura J, Gallagher JP. Histamine depolarizes rat medial vestibular nucleus neurons recorded intracellularly in vitro. Neurosci Lett. 1990 Feb 16;109(3):287-92. doi: 10.1016/0304-3940(90)90009-x. PubMed 2139500 ↗
  • Pyykko I, Schalen L, Matsuoka I. Transdermally administered scopolamine vs. dimenhydrinate. II. Effect on different types of nystagmus. Acta Otolaryngol. 1985 May-Jun;99(5-6):597-604. doi: 10.3109/00016488509182266. PubMed 4024910 ↗
  • Tal D, Hershkovitz D, Kaminski G, Bar R. Vestibular evoked myogenic potential threshold and seasickness susceptibility. J Vestib Res. 2006;16(6):273-8. PubMed 17726280 ↗
  • Bar R, Gil A, Tal D. Safety of double-dose transdermal scopolamine. Pharmacotherapy. 2009 Sep;29(9):1082-8. doi: 10.1592/phco.29.9.1082. PubMed 19698013 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03270839
Lead sponsor
Medical Corps, Israel Defense Force
Responsible party
Dror Tal (Head of Motion Sickness and Human Performance Laboratory, Principal Investigator, Medical Corps, Israel Defense Force) — Principal investigator
First posted
Sep 1, 2017
Start date
Jun 1, 2017
Primary completion
Sep 30, 2019
Completion
Jan 1, 2020
Last update
Oct 3, 2025

Study contacts

Dror Tal, PhD
principal investigator · Head of Motion Sickness and Human Performance Laboratory, Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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