UnknownPhase 3

Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo

1,000 participantsStarted 2024-05-01

Plain-language summary

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria; * patients between 18 and 70 years of age * a chief complaint of acute peripheral vertigo (APV) (sensation of spinning, which was worsened by movement and sudden in onset) were eligible if the treating emergency physician diagnosed an episode of vertigo that was peripheral in nature. Exclusion Criteria: -Patients aged \> 70 years as central vertigo , -patients with a focal neurologic deficit, pregnancy, history of allergic reaction or contraindication to any of the test drugs, history of enrolment in a previous clinical drug trial, * history of recent ingestion (within 24 hours) of a sedative, antihistamine, antipsychotic, or opioid, * history of syncope or cardiac event, considerations of a central origin for vertigo -evidence of drug-induced vertigo or orthostatic hypotension -history of mental or neurological illness.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual analogue scale (VAS)-3H

Timeframe: 3 hours

Trial details

NCT IDNCT06293989

SponsorUniversity of Monastir

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-30

Contact for this trial

NOUIRA Semir, PR

73106000 semir.nouira@rns.tn

View on ClinicalTrials.gov More Vertigo, Peripheral trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.