Motion Sickness Medications and Vestibular Time Constant

Drug Reaction Clinical Trial

Official title:

Motion Sickness Medications and Vestibular Time Constant

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03270839
• Other study ID #: 1723-2016
• Status: Recruiting
• Phase: Phase 4
• First received: April 2, 2017
• Last updated: August 31, 2017
• Start date: June 1, 2017
• Est. completion date: May 1, 2018

Study information

• Verified date: August 2017
• Source: Medical Corps, Israel Defense Force
• Contact: Dror Tal, PhD
• Phone: +972549096080
• Email: tldror1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Reaction
• Drug-Related Side Effects and Adverse Reactions
• Motion Sickness

Intervention

Drug:
• Bonine 25Mg Chewable Tablet
Motion sickness drug
• Kwells
Motion sickness drug
• Placebo Oral Tablet
No active substance in the tablet

Locations

Country	Name	City	State
Israel	Israeli Navy Medical Institute	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

References & Publications (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. — View 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. — View 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. — View 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. Review. — View Citation

Ishiyama A, López 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. — View 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. — View Citation

Pyykkö I, Schalén 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.