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Motion Sickness Medications and Vestibular Time Constant

Primary Purpose

Drug Reaction

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Bonine 25Mg Chewable Tablet
Kwells
Placebo Oral Tablet
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Drug Reaction

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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:

  • 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.

Sites / Locations

  • Israeli Navy Medical InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

Responsive to Scopolamine (Active)

Responsive to Scopolamine (Placebo)

Non-responsive to Scopolamine (Active)

Non-responsive to Scopolamine (Placebo)

Responsive to Meclizine (Active)

Responsive to Meclizine (Placebo)

Non-responsive to Meclizine (Active)

Non-responsive to Meclizine (Placebo)

Arm Description

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Vestibular Time Constant Change/differential
One of the parameters measured in step velocity test [Sec]
Step Velocity Test Gain Change/differential
One of the parameters measured in step velocity test [0-1]
Optokinetic After Nystagmus (OKAN) Gain Change/differential
One of the parameters measured in optokinetic test [0-1]
Optokinetic After Nystagmus (OKAN) Time Constant Change/differential
One of the parameters measured in optokinetic test [Sec]
Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential
One of the parameters measured in optokinetic test [Deg/Sec]
Pupil Size Change/differential
Using pupil size chart [Mm]
Pupil Accommodation and Convergation Change/differential
Eye test for drugs side effects.
Side Effects Questionnaire Change/differential
Questionnaire of drugs' side effects.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2017
Last Updated
August 31, 2017
Sponsor
Medical Corps, Israel Defense Force
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1. Study Identification

Unique Protocol Identification Number
NCT03270839
Brief Title
Motion Sickness Medications and Vestibular Time Constant
Official Title
Motion Sickness Medications and Vestibular Time Constant
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
May 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Corps, Israel Defense Force

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Reaction

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Responsive to Scopolamine (Active)
Arm Type
Active Comparator
Arm Description
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
Arm Title
Responsive to Scopolamine (Placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Arm Title
Non-responsive to Scopolamine (Active)
Arm Type
Active Comparator
Arm Description
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
Arm Title
Non-responsive to Scopolamine (Placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Arm Title
Responsive to Meclizine (Active)
Arm Type
Active Comparator
Arm Description
Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day )
Arm Title
Responsive to Meclizine (Placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Arm Title
Non-responsive to Meclizine (Active)
Arm Type
Active Comparator
Arm Description
Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day )
Arm Title
Non-responsive to Meclizine (Placebo)
Arm Type
Placebo Comparator
Arm Description
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
Intervention Type
Drug
Intervention Name(s)
Bonine 25Mg Chewable Tablet
Other Intervention Name(s)
Meclizine
Intervention Description
Motion sickness drug
Intervention Type
Drug
Intervention Name(s)
Kwells
Other Intervention Name(s)
Scopolamine
Intervention Description
Motion sickness drug
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Intervention Description
No active substance in the tablet
Primary Outcome Measure Information:
Title
Vestibular Time Constant Change/differential
Description
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.
Title
Step Velocity Test Gain Change/differential
Description
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.
Title
Optokinetic After Nystagmus (OKAN) Gain Change/differential
Description
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.
Title
Optokinetic After Nystagmus (OKAN) Time Constant Change/differential
Description
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.
Title
Optokinetic After Nystagmus (OKAN) Slow Phase velocity Sum Change/differential
Description
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.
Title
Pupil Size Change/differential
Description
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.
Title
Pupil Accommodation and Convergation Change/differential
Description
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.
Title
Side Effects Questionnaire Change/differential
Description
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dror Tal, PhD
Phone
+972549096080
Email
tldror1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Tal, PhD
Organizational Affiliation
Head of Motion Sickness and Human Performance Laboratory, Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Israeli Navy Medical Institute
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dror Tal, PhD
Phone
+972549096080
Email
tldror1@gmail.com
First Name & Middle Initial & Last Name & Degree
Daniel Lagami, BSc

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1859339
Citation
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.
Results Reference
background
PubMed Identifier
21287155
Citation
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.
Results Reference
background
PubMed Identifier
25502048
Citation
Golding JF, Gresty MA. Pathophysiology and treatment of motion sickness. Curr Opin Neurol. 2015 Feb;28(1):83-8. doi: 10.1097/WCO.0000000000000163.
Results Reference
background
PubMed Identifier
9303164
Citation
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.
Results Reference
background
PubMed Identifier
2139500
Citation
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.
Results Reference
background
PubMed Identifier
4024910
Citation
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.
Results Reference
background
PubMed Identifier
17726280
Citation
Tal D, Hershkovitz D, Kaminski G, Bar R. Vestibular evoked myogenic potential threshold and seasickness susceptibility. J Vestib Res. 2006;16(6):273-8.
Results Reference
background
PubMed Identifier
19698013
Citation
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.
Results Reference
background

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Motion Sickness Medications and Vestibular Time Constant

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