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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03325790
Other study ID # SPI-1005-251
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 28, 2017
Est. completion date April 30, 2019

Study information

Verified date August 2023
Source Sound Pharmaceuticals, Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Study participants will be randomized to SPI-1005 or placebo in this double-blind study to evaluate both safety and efficacy of the investigational treatment. Participants, aged 18-75 years, with probable or definite Meniere's disease will undergo baseline testing to assess severity of sensorineural hearing loss, tinnitus and vertigo. During the study, and 28 days after completion of treatment, participants will be evaluated for safety (adverse events, physical examinations, vital signs and clinical laboratory testing (CBC,serum chemistry). Trough plasma levels of ebselen and its major metabolite will be determined using liquid chromatography-mass spectrometry (LCMS) at specified visits. Additionally, plasma will be analyzed for selenium at the corresponding visits. The effect of SPI-1005 on hearing and balance will be evaluated. Tinnitus (TFI) and vertigo (VSS) will be evaluated at baseline, during and study treatment.


Recruitment information / eligibility

Status Completed
Enrollment 149
Est. completion date April 30, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
200mg SPI-1005 BID
Active: low dose
400mg SPI-1005 BID
Active: high dose
Other:
Placebo
Placebo Comparator

Locations

Country Name City State
United States MUSC Charleston South Carolina
United States CEENTA Charlotte North Carolina
United States UT Southwestern Dallas Texas
United States Ccent/Cccr Fresno California
United States KUMC Kansas City Kansas
United States Advanced ENT & Allergy Louisville Kentucky
United States UMiami Miami Florida
United States ENT and Allergy Associates, LLP New York New York
United States TJU Philadelphia Pennsylvania
United States UCSD San Diego California
United States UCSF San Francisco California
United States Northwest Ear, Inc. Seattle Washington
United States Georgetown University Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Sound Pharmaceuticals, Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment Emergent Adverse Events (TEAE) 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
Primary Efficacy of SPI-1005 on Hearing Loss Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry 8 weeks
Primary Efficacy of SPI-1005 on Word Recognition Score 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
Primary Efficacy of SPI-1005 on Tinnitus 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
Primary Efficacy of SPI-1005 on Tinnitus Loudness 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
Primary Efficacy of SPI-1005 on Vertigo Improvement in Vertigo Symptom Scale (VSS) from baseline. VSS Total Scale: 0-60, in which a higher score means a worse outcome 8 weeks
Secondary Trough Plasma Concentration of SPI-1005 Trough plasma concentration of SPI-1005 (ebselen) will be determined at certain time intervals 2 weeks, 4 weeks, 8 weeks
See also
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