At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 254 enrolled / 254 target
Drug / intervention
Ebselen +1 moredrug
Likely dose
400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere's Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
In Brief
A Phase 3 clinical trial evaluating Ebselen and Placebo for Meniere Disease and Ménière. Completed, enrolled 254 participants across 12 sites.
Detailed Summary
The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeniere Disease, Ménière
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartAug 2022
Primary CompletionSep 2023
Study CompletionJul 2024
TodayJul 2026
First PostedDec 21, 2020
Enrollment StartAug 2, 2022
Primary CompletionSep 19, 2023
Study CompletionJul 25, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.5 years ago
Arms & Interventions
SPI-1005 400 mg BIDexperimental
Oral administration of SPI-1005 400 mg BID for 28 days, with 84-day followup
Drug: Ebselen
Placeboplacebo_comparator
Oral administration of matching placebo BID for 28 days, with 84-day followup
Drug: Placebo
Interventions
Ebselendrug
Glutathione peroxidase mimetic
Placebodrug
Matching placebo containing excipients