SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
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|ClinicalTrials.gov Identifier: NCT02819856|
Recruitment Status : Enrolling by invitation
First Posted : June 30, 2016
Last Update Posted : December 9, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Ototoxicity||Drug: Placebo Drug: SPI-1005 Ebselen 200mg Capsule x1 Drug: SPI-1005 Ebselen 200mg Capsule x2 Drug: SPI-1005 Ebselen 200mg Capsule x3||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||July 21, 2017|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Placebo Comparator: SPI-1000 Capsule 0mg Ebselen Placebo
0mg Ebselen SPI-1000 bid po x 21d
0 mg SPI-1005 bid po x 21d
Other Name: SPI-1000
Experimental: SPI-1005 Ebselen 200mg Capsule x1
200mg SPI-1005 bid po x 21d Low Dose Arm
Drug: SPI-1005 Ebselen 200mg Capsule x1
200 mg SPI-1005 bid po x21d
Other Name: SPI-1005 Low Dose
Experimental: SPI-1005 Ebselen 200mg Capsule x2
400mg SPI-1005 bid po x 21d Mid Dose Arm
Drug: SPI-1005 Ebselen 200mg Capsule x2
400 mg SPI-1005 bid po x 21d
Other Name: SPI-1005 Mid Dose
Experimental: SPI-1005 Ebselen 200mg Capsule x3
600mg SPI-1005 bid po x 21d High Dose Arm
Drug: SPI-1005 Ebselen 200mg Capsule x3
600 mg SPI-1005 bid po x 21d
Other Name: SPI-1005 High Dose
- Number of participants with sensorineural hearing loss as a measure of safety and efficacy of SPI-1005 [ Time Frame: 7 weeks ]Determination of sensorineural hearing loss using pure-tone audiometry
- Distortion Product Otoacoustic Emissions [ Time Frame: 7 weeks ]Changes in hearing thresholds using pure-tone audiometry with extended high frequency testing
- Speech discrimination [ Time Frame: 7 weeks ]Change in Words in noise test (WINT) score
- Tinnitus severity [ Time Frame: 7 weeks ]Changes in Tinnitus Functional Index (TFI) score
- Vertigo severity [ Time Frame: 7 weeks ]vertigo symptom scale
- Changes in lung function [ Time Frame: 7 weeks ]Evaluation of lung function using FEV1
- Trough Level of SPI-1005 at 200, 400, and 600 mg Ebselen po bid x 21d [ Time Frame: 7 weeks ]Plasma ebselen and major metabolite quantified in plasma by LC-MS/MS
- Pharmacogenomics [ Time Frame: 5 weeks ]Pharmacogenomics analysis will explore SPI-1005 as an inducer of gene expression for Nrf2, glutathione peroxidase-1, hemeoxygenase-1, and thioredoxin class of redox proteins.
- Pharmacodynamics of Nrf2 [ Time Frame: 5 weeks ]Explore SPI-1005 on the level of Nrf2 by PCR
- Pharmacodynamics of Glutathione, cysteine and cystine [ Time Frame: 5 weeks ]Explore SPI-1005 on the level of Glutathione, cysteine and cystine measured in µM.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819856
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Chair:||Jonathan Kil, MD||SOUND PHARMACEUTICALS, INC.|
|Responsible Party:||Sound Pharmaceuticals, Incorporated|
|Other Study ID Numbers:||
|First Posted:||June 30, 2016 Key Record Dates|
|Last Update Posted:||December 9, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Drug-Related Side Effects and Adverse Reactions
Wounds and Injuries
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action