- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03325790
SPI-1005 for the Treatment of Patients With Meniere's Disease
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Fresno, California, United States, 93720
- Ccent/Cccr
-
San Diego, California, United States, 92093
- UCSD
-
San Francisco, California, United States, 94115
- UCSF
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20057
- Georgetown University
-
-
Florida
-
Miami, Florida, United States, 33146
- UMiami
-
-
Kansas
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Kansas City, Kansas, United States, 66160
- KUMC
-
-
Kentucky
-
Louisville, Kentucky, United States, 40207
- Advanced ENT & Allergy
-
-
New York
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New York, New York, United States, 10017
- ENT and Allergy Associates, LLP
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28210
- CEENTA
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19144
- TJU
-
-
South Carolina
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Charleston, South Carolina, United States, 29425
- MUSC
-
-
Texas
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Dallas, Texas, United States, 75390
- UT Southwestern
-
-
Washington
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Seattle, Washington, United States, 98104
- Northwest Ear, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult male and female patients, 18-75 years of age at the time of enrollment.
- Diagnosis of probable or definitive Meniere's disease by American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) 1995 criteria.
- Two of three active symptoms including vertigo or disequilibrium, fluctuating hearing loss, or tinnitus within the 3 months prior to study enrollment.
- Hearing loss of ≥ 30 decibels (dBHL) at either 250, 500 or 1000 Hz.
- Voluntary consent to participate in the study.
- Male subjects that are willing to use condoms throughout the study period and 90-days following study completion even if not fertile.
Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to screening and throughout the study or be using one of the following acceptable birth control methods:
- Intrauterine Device in place for at least 3 months prior to study; 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 and through study completion; or
- Surgical sterilization (vasectomy) of partner at least 6 months prior to study enrollment.
- Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study enrollment, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 1 year since last menses.
Exclusion Criteria:
- Current use of or within 60 days prior to study IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
- History of otosclerosis or vestibular schwannoma.
- History of significant middle ear or inner ear surgery.
- Current conductive hearing loss, otitis media, or mixed hearing loss.
- Significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease.
- Current use or within 30 days prior to study enrollment systemic steroids or drugs known to be strong inhibitors or inducers of cytochrome P450 enzymes.
- Hypersensitivity or idiosyncratic reaction to compounds related to ebselen or selenium.
- Female patients who are pregnant or breastfeeding.
- Participation in another interventional drug or device study within 30 days prior to study consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo Comparator
|
Experimental: 200mg SPI-1005 twice daily (BID)
200mg SPI-1005 BID
|
Active: low dose
Other Names:
|
Experimental: 400mg SPI-1005 BID
|
Active: high dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of SPI-1005 on Hearing Loss
Time Frame: 8 weeks
|
Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry
|
8 weeks
|
Efficacy of SPI-1005 on Word Recognition Score
Time Frame: 8 weeks
|
Improvement in Words-in-Noise (WIN) test score from baseline.
WIN test score, 0-35 words, in which a higher score means a better outcome.
|
8 weeks
|
Efficacy of SPI-1005 on Tinnitus
Time Frame: 8 weeks
|
Improvement in the Tinnitus Functional Index (TFI) from baseline.
TFI Total Score: 0-100, in which a higher score means a worse outcome.
|
8 weeks
|
Efficacy of SPI-1005 on Tinnitus Loudness
Time Frame: 8 weeks
|
Improvement in Tinnitus Loudness (TL) on response to Tinnitus Functional Index Question Number 2. Question Number 2: "How Strong or Loud is your tinnitus?": 0-10, in which a higher score means a worse outcome. |
8 weeks
|
Efficacy of SPI-1005 on Vertigo
Time Frame: 8 weeks
|
Improvement in Vertigo Symptom Scale (VSS) from baseline.
VSS Total Scale: 0-60, in which a higher score means a worse outcome
|
8 weeks
|
Number of Participants With Treatment Emergent Adverse Events (TEAE)
Time Frame: 8 weeks
|
Number and severity of adverse events in patients treated with placebo versus SPI-1005. Outcome Measure 1 includes all adverse events, including those which are not reported in the Adverse Event module, i.e., adverse events which did not result in death, were not Serious Adverse Events, and which were below the frequency threshold (5%) in any arm as required for reporting. |
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trough Plasma Concentration of SPI-1005
Time Frame: 2 weeks, 4 weeks, 8 weeks
|
Trough plasma concentration of SPI-1005 (ebselen) will be determined at certain time intervals
|
2 weeks, 4 weeks, 8 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Jonathan Kil, MD, Sound Pharmaceuticals, Inc.
Publications and helpful links
General Publications
- Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2022 Jan;413:108209. doi: 10.1016/j.heares.2021.108209. Epub 2021 Feb 19.
- Kil J, Pierce C, Tran H, Gu R, Lynch ED. Ebselen treatment reduces noise induced hearing loss via the mimicry and induction of glutathione peroxidase. Hear Res. 2007 Apr;226(1-2):44-51. doi: 10.1016/j.heares.2006.08.006. Epub 2006 Oct 6.
- Kil J, Lobarinas E, Spankovich C, Griffiths SK, Antonelli PJ, Lynch ED, Le Prell CG. Safety and efficacy of ebselen for the prevention of noise-induced hearing loss: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2017 Sep 2;390(10098):969-979. doi: 10.1016/S0140-6736(17)31791-9. Epub 2017 Jul 14.
- Lynch E, Kil J. Development of ebselen, a glutathione peroxidase mimic, for the prevention and treatment of noise-induced hearing loss. Semin Hear 2009; 30(1):47-55
- Nelson L, Johns JD, Gu S, Hoa M. Utilizing Single Cell RNA-Sequencing to Implicate Cell Types and Therapeutic Targets for SSNHL in the Adult Cochlea. Otol Neurotol. 2021 Dec 1;42(10):e1410-e1421. doi: 10.1097/MAO.0000000000003356.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Otorhinolaryngologic Diseases
- Labyrinth Diseases
- Ear Diseases
- Endolymphatic Hydrops
- Meniere Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gastrointestinal Agents
- Neuroprotective Agents
- Protective Agents
- Anti-Ulcer Agents
- Antioxidants
- Ebselen
Other Study ID Numbers
- SPI-1005-251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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