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

Phase 3

Not yet recruiting

• Conditions: Vertigo, Peripheral
• Interventions: Drug: Diazepam 10 mg; Drug: Diazepam 5mg; Drug: Placebo

• Registration Number: NCT06293989
• Lead Sponsor: University of Monastir

Brief 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

Detailed Description

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. The study should be reviewed and receive approval from the institutional review board. Principles of the Helsinki Declaration are considered All patients should provide their informed consent prior to enrollment.

Study Timeline

• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-05
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-02
• Study Start: 2024-05-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diazepam 10 mg	Diazepam 10 mg	Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug.
diazepam 5 mg	Diazepam 5mg	Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug.
placebo	Placebo	Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug.

Primary Outcome Measures

Name	Time	Method
Visual analogue scale (VAS)-3H	3 hours	the frequency of vertigo resolution defined as a reduction of at least 50% in VAS at 3-hour(VAS-3H) compared to baseline VAS (VAS baseline) during movement (VAS ambulation).

Secondary Outcome Measures

Name	Time	Method
the Delta-VAS	3 hous	the delta VAS was calculated as \[(VAS baseline- VAS3H)/VAS baseline\]\*100
number of patients with adverse effects	3 hours	number of patients with adverse effects
the time required to reach the resolution of the vertigo crisis	3 hours	the time required to reach the resolution of the vertigo crisis
Patients satisfaction	3 hours	patient satisfaction with likert scale