Motion Sickness Medications and Vestibular Time Constant

NCT03270839 | Completed Phase 4 FDA Drug

• 1 other identifier: 1723-2016
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Reaction

Outcome Measures

Primary Outcomes (8)

• Vestibular Time Constant Change/differential

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

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

• Step Velocity Test Gain Change/differential

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

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

• Optokinetic After Nystagmus (OKAN) Gain Change/differential

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

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

• Optokinetic After Nystagmus (OKAN) Time Constant Change/differential

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

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

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

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

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

• Pupil Size Change/differential

  Using pupil size chart \[Mm\]

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

• Pupil Accommodation and Convergation Change/differential

  Eye test for drugs side effects.

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

• Side Effects Questionnaire Change/differential

  Questionnaire of drugs' side effects.

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

Study Arms (8)

Responsive to Scopolamine (Active)

ACTIVE COMPARATOR

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

Drug: Kwells

Responsive to Scopolamine (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Non-responsive to Scopolamine (Active)

ACTIVE COMPARATOR

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

Drug: Kwells

Non-responsive to Scopolamine (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Responsive to Meclizine (Active)

ACTIVE COMPARATOR

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

Drug: Bonine 25Mg Chewable Tablet

Responsive to Meclizine (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Non-responsive to Meclizine (Active)

ACTIVE COMPARATOR

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

Drug: Bonine 25Mg Chewable Tablet

Non-responsive to Meclizine (Placebo)

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Bonine 25Mg Chewable Tablet DRUG

Motion sickness drug

Also known as: Meclizine

Non-responsive to Meclizine (Active); Responsive to Meclizine (Active)

Kwells DRUG

Motion sickness drug

Also known as: Scopolamine

Non-responsive to Scopolamine (Active); Responsive to Scopolamine (Active)

Placebo Oral Tablet DRUG

No active substance in the tablet

Also known as: Placebo

Non-responsive to Meclizine (Placebo); Non-responsive to Scopolamine (Placebo); Responsive to Meclizine (Placebo); Responsive to Scopolamine (Placebo)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Corps, Israel Defense Force: lead

Study Sites (1)

Israeli Navy Medical Institute

Haifa, Israel

Location

Related Publications (8)

• 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.

  PMID: 1859339 BACKGROUND

• Adamenko VM, Evangelopoulou T, Yfantopoulos J. Kirlian photography--a tool in the diagnosing of psychopathology. J Biol Photogr. 1988 Jul;56(3):85-8. No abstract available.

  PMID: 3182575 BACKGROUND

• Golding JF, Gresty MA. Pathophysiology and treatment of motion sickness. Curr Opin Neurol. 2015 Feb;28(1):83-8. doi: 10.1097/WCO.0000000000000163.

  PMID: 25502048 BACKGROUND

• 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.

  PMID: 9303164 BACKGROUND

• 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.

  PMID: 2139500 BACKGROUND

• 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.

  PMID: 4024910 BACKGROUND

• Tal D, Hershkovitz D, Kaminski G, Bar R. Vestibular evoked myogenic potential threshold and seasickness susceptibility. J Vestib Res. 2006;16(6):273-8.

  PMID: 17726280 BACKGROUND

• 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.

  PMID: 19698013 BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Meclizine; Scopolamine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Dror Tal, PhD

  Head of Motion Sickness and Human Performance Laboratory, Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Motion Sickness and Human Performance Laboratory, Principal Investigator

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: September 1, 2017
• Study Start: June 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: January 1, 2020
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)