SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-21

Study Completion Date

2023-04-07

Brief Summary

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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.

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Detailed Description

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Randomized, double-blind, placebo-controlled study to evaluate the safety, and efficacy of SPI-1005 in Cystic Fibrosis patients with Acute Pulmonary Exacerbation receiving intravenous tobramycin at risk for ototoxicity. All patients will undergo baseline testing and have their severity of lung function, sensorineural hearing loss, tinnitus and vertigo determined before the start of SPI-1005 treatment. SPI-1005 treatment will start within first two days of IV tobramycin treatment and be administered concomitantly. At the end of the 21-day course of SPI-1005 and 28 days following the cessation of SPI-1005, patients will have their hearing loss, tinnitus and vertigo reassessed. Assessments may also include additional audiometric and pulmonary testing, and additional follow-up testing.

Conditions

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Ototoxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SPI-1000 Capsule 0mg Ebselen Placebo

0mg Ebselen SPI-1000 bid po x 21d

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mg SPI-1005 bid po x 21d

SPI-1005 Ebselen 200mg Capsule x1

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

Group Type EXPERIMENTAL

SPI-1005 Ebselen 200mg Capsule x1

Intervention Type DRUG

200 mg SPI-1005 bid po x21d

SPI-1005 Ebselen 200mg Capsule x2

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

Group Type EXPERIMENTAL

SPI-1005 Ebselen 200mg Capsule x2

Intervention Type DRUG

400 mg SPI-1005 bid po x 21d

SPI-1005 Ebselen 200mg Capsule x3

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

Group Type EXPERIMENTAL

SPI-1005 Ebselen 200mg Capsule x3

Intervention Type DRUG

600 mg SPI-1005 bid po x 21d

Interventions

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Placebo

0 mg SPI-1005 bid po x 21d

Intervention Type DRUG

SPI-1005 Ebselen 200mg Capsule x1

200 mg SPI-1005 bid po x21d

Intervention Type DRUG

SPI-1005 Ebselen 200mg Capsule x2

400 mg SPI-1005 bid po x 21d

Intervention Type DRUG

SPI-1005 Ebselen 200mg Capsule x3

600 mg SPI-1005 bid po x 21d

Intervention Type DRUG

Other Intervention Names

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SPI-1000 SPI-1005 Low Dose SPI-1005 Mid Dose SPI-1005 High Dose

Eligibility Criteria

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Inclusion Criteria

* Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary exacerbation.
* Voluntarily consent to participate in the study.
* Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods:
* Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or IUD in place for at least 3 months prior to study through study completion; or Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or Stable hormonal contraceptive for at least 3 months prior to study through study completion.
* Ability to perform all behavioral tests as indicated.

Exclusion Criteria

* Current use or within 60 days prior to study enrollment the following IV ototoxic medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide).
* History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma.
* History of middle ear or inner ear surgery.
* Current conductive hearing loss or middle ear effusion.
* Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or psychiatric disease.
* History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
* Participation in another investigational drug or device study within 30 days prior to study enrollment.
* Female patients who are pregnant or breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No