CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled / 40 target
Drug / intervention
Placebo +3 moredrug
Likely dose
SPI-1005 Ebselen 200mg Capsule x1from 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.

Search/NCT02819856
NCT02819856Phase 2CompletedUpdate Overdue (0.4/mo)Completion was 38mo ago
CompareCT.gov

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for Ototoxicity

Sound Pharmaceuticals, Incorporated·interventional·Posted Jun 30, 2016·Updated Jun 25, 2026

In Brief

A Phase 2 clinical trial evaluating Placebo, SPI-1005 Ebselen 200mg Capsule x1, and 2 other interventions for Ototoxicity. Completed, enrolled 40 participants across 1 site.

Signals

Enrollment appears stalled

Detailed Summary

The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK), Physical Exam, Adverse Events (AEs) and Labs baseline to post-treatment. The secondary objectives of this study are to determine Pharmacogenomics and Pharmacodynamics of SPI-1005.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtotoxicity
CountriesUnited States
CollaboratorsMedical University of South Carolina, Cystic Fibrosis Foundation

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 30, 2016
Enrollment StartJul 21, 2017
Primary CompletionApr 7, 2023
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.0 years ago

Arms & Interventions

SPI-1000 Capsule 0mg Ebselen Placeboplacebo_comparator

0mg Ebselen SPI-1000 bid po x 21d

Drug: Placebo
SPI-1005 Ebselen 200mg Capsule x1experimental

200mg SPI-1005 bid po x 21d Low Dose Arm

Drug: SPI-1005 Ebselen 200mg Capsule x1
SPI-1005 Ebselen 200mg Capsule x2experimental

400mg SPI-1005 bid po x 21d Mid Dose Arm

Drug: SPI-1005 Ebselen 200mg Capsule x2
SPI-1005 Ebselen 200mg Capsule x3experimental

600mg SPI-1005 bid po x 21d High Dose Arm

Drug: SPI-1005 Ebselen 200mg Capsule x3

Interventions

Placebodrug

0 mg SPI-1005 bid po x 21d

SPI-1005 Ebselen 200mg Capsule x1drug

200 mg SPI-1005 bid po x21d

SPI-1005 Ebselen 200mg Capsule x2drug

400 mg SPI-1005 bid po x 21d

SPI-1005 Ebselen 200mg Capsule x3drug

600 mg SPI-1005 bid po x 21d