Can a common Motion-Sickness drug tame vertigo as well as the standard?
NCT ID NCT02112578
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This trial tests whether meclizine, a drug often used for motion sickness, works as well as dimenhydrinate for controlling acute vertigo symptoms that come from inner-ear problems. Adults aged 18 to 64 with moderate to severe vertigo take one of the two drugs three times a day for up to 30 days. Researchers track symptom scores, quality of life, and daytime sleepiness to see if meclizine is a suitable alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- meclizine (an antihistamine) compared with dimenhydrinate (another antihistamine)
- What this could lead to
- If meclizine works as well as dimenhydrinate, it could offer another option for quickly easing vertigo symptoms with possibly less daytime sleepiness.
- What could go wrong
- This is a phase 3 trial, but success is not guaranteed. The drugs may prove unequal in effect, and side effects like drowsiness could still be a problem.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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292 people
The number who actually took part.
- Started
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Nov 2016
- Finished
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Dec 2017
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men and women aged over 18 years and less than 65; * Presence of vertigo episodes of vestibular origin (peripheral ) of moderate intensity , strong or very strong according to the VS range ; * Participants who are able to swallow tablets / capsules; * Participants able to understand the guidance and care of this study and cooperative ; * Participants with the requisite understanding, in accordance with Good Clinical Practice Research Document of the Americas. Exclusion Criteria: * Use of meclizine or dimenidrynate in the actual event or in the past 15 days; * Use of alcohol in the past 48 hours; * Presence of vomiting which prevent the ingestion of tablets; * Pregnancy or breastfeeding; * Presence of clinical condition that determines contraindication to the active substances : convulsions , suspected intracranial compressive processes , closed-angle glaucoma , prostatic adenoma with urinary disorders , liver diseases , endocrine , renal, and / or uncontrolled cardiovascular , Parkinson's disease, porphyria, know history of hipersensibility to the Actives or Excipients from the study medications; * Malignancies History , even if no evidence of active disease for less than five years . Those without active disease for more than five years may be included; * Uncontrolled systemic arterial hypertension ( \> 140/90 mmHg ); * Decompensated diabetes mellitus (blood glucose at any time \> 200 mg / dL ); * Participants with asthma or chronic obstructive pulmonary disease; * Participants making use of antihistamines with anti-vertigo effect ( betahistine, meclizine , diphenidol ) , drugs with antagonist calcium channel action ( cinnarizine , flunarizine ) , anticholinergic drugs ( metoclopramide , dimenhydrinate , meclizine , diphenidol , scopolamine, ondansetron, granisetron ) , antiseizure drugs ( diazepam , clonazepam , carbamazepine ) and other central nervous system depressants; * Participants with central origin vertigo or non-vestibular; * Participants with positional benign positional paroxysmal vertigo (bppv).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Alergoalpha
Barueri, São Paulo, 06454010, Brazil
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CCBR SP
São Paulo, São Paulo, 04063001, Brazil
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Clinica de Alergia MarttiAntila
Sorocaba, São Paulo, 18040425, Brazil
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Clinilive
Maringá, Paraná, Brazil
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ISPEM
São José dos Campos, São Paulo, 12243280, Brazil
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Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil
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Pesquisare Saude S/S Ltda
Santo André, São Paulo, 09080110, Brazil