At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 149 enrolled
Drug / intervention
200mg SPI-1005 BID +2 moredrug
Likely dose
200mg SPI-1005 BIDfrom 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 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease
In Brief
A Phase 2 clinical trial evaluating 200mg SPI-1005 BID, 400mg SPI-1005 BID, and 1 other intervention for Meniere's Disease. Completed, enrolled 149 participants across 13 sites.
Detailed Summary
This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMeniere's Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartSep 2017
First PostedOct 2017
Primary CompletionApr 2019
TodayJul 2026
First PostedOct 30, 2017
Enrollment StartSep 28, 2017
Primary CompletionApr 30, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.7 years ago
Interventions
200mg SPI-1005 BIDdrug
Active: low dose
400mg SPI-1005 BIDdrug
Active: high dose
Placeboother
Placebo Comparator