- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03270839
Motion Sickness Medications and Vestibular Time Constant
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Dror Tal, PhD
- Phone Number: +972549096080
- Email: tldror1@gmail.com
Study Locations
-
-
-
Haifa, Israel
- Recruiting
- Israeli Navy Medical Institute
-
Contact:
- Dror Tal, PhD
- Phone Number: +972549096080
- Email: tldror1@gmail.com
-
Sub-Investigator:
- Daniel Lagami, BSc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Responsive to Scopolamine (Active)
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
|
Motion sickness drug
Other Names:
|
Placebo Comparator: Responsive to Scopolamine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
|
No active substance in the tablet
Other Names:
|
Active Comparator: Non-responsive to Scopolamine (Active)
Scopolamine administration - subject will take 1 tablet per os (Kwells, Hyoscine Hydrobromide 0.3mg, 1*day )
|
Motion sickness drug
Other Names:
|
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)
|
No active substance in the tablet
Other Names:
|
Active Comparator: Responsive to Meclizine (Active)
Meclizine administration - subject will take 1 tablet per os (Bonine 25Mg Chewable Tablet, Meclizine Hydrochloride 25mg, 1*day )
|
Motion sickness drug
Other Names:
|
Placebo Comparator: Responsive to Meclizine (Placebo)
Placebo administration - subject will take 1 tablet per os (Placebo Oral Tablet, no active substance in the tablet)
|
No active substance in the tablet
Other Names:
|
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 )
|
Motion sickness drug
Other Names:
|
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)
|
No active substance in the tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vestibular Time Constant Change/differential
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dror Tal, PhD, Head of Motion Sickness and Human Performance Laboratory, Principal Investigator
Publications and helpful links
General 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.
- 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.
- Golding JF, Gresty MA. Pathophysiology and treatment of motion sickness. Curr Opin Neurol. 2015 Feb;28(1):83-8. doi: 10.1097/WCO.0000000000000163.
- 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.
- 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.
- 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.
- Tal D, Hershkovitz D, Kaminski G, Bar R. Vestibular evoked myogenic potential threshold and seasickness susceptibility. J Vestib Res. 2006;16(6):273-8.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Drug-Related Side Effects and Adverse Reactions
- Motion Sickness
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Antiemetics
- Gastrointestinal Agents
- Adjuvants, Anesthesia
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Mydriatics
- Meclizine
- Scopolamine
Other Study ID Numbers
- 1723-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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