Last reviewed · How we verify

NCT06267924

SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines

Completed NA Last updated 30 January 2025
What this trial tests

NA trial testing Otoband Experimental in Vestibular Migraine in 322 participants. Completed in 8 January 2025.

Timeline
6 March 2024
Primary endpoint
9 December 2024
8 January 2025

Quick facts

Lead sponsorOtolith Labs
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment322
Start date6 March 2024
Primary completion9 December 2024
Estimated completion8 January 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Otolith Labs

Who can join

Adults 18 to 75, any sex, with Vestibular Migraine or Migraine Associated Vertigo. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo. Participants will be: * Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device) * Randomized and stratified into groups based on the referring clinic to be assigned one study device * Asked to use the study device as instructed by the study coordinator * Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators * Asked to provide their vertigo diagnosis from their physician * Compensated for their participation Researchers will compare the randomized groups to determine which group responds better to which device.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Otoband Experimental

Trials testing the same drug.

Other recruiting trials for Vestibular Migraine

Currently open trials in the same condition.

Other Otolith Labs trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06267924.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing