Study to Evaluate SPI-1005 in Adults With Meniere's Disease

Meniere's Disease Clinical Trial

Official title:

Phase 1b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of SPI-1005 in Meniere's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603081
• Other study ID #: SPI-1005-151
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2015
• Est. completion date: August 2017

Study information

• Verified date: March 2021
• Source: Sound Pharmaceuticals, Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere's disease.

Description:

Randomized, double-blind, placebo-controlled safety, pharmacokinetic, pharmacodynamic study of oral SPI-1005 in adults with Meniere's disease. All subjects will undergo baseline audiometric testing and have their severity of sensorineural hearing loss, tinnitus and vertigo determined before the start of a 21-day course of treatment with SPI-1005 or placebo. During treatment with SPI-1005, and 7 days and 28 days following the cessation of SPI-1005, subjects will have their hearing loss, tinnitus and vertigo assessed. Additional testing including electrocochleography will be performed at baseline, at the end of SPI-1005 treatment, and 28 days after the SPI-1005 treatment has stopped. Six outpatient visits will be performed over a 7-week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of probable or definite Meniere's Disease by AAO-HNS 1995 criteria within 12 months of study enrollment;
• 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; or
• Surgical sterilization (vasectomy) of partner at least 6 months prior to study.
• Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study) or be at least 3 years since last menses.

Exclusion Criteria:

• Current use or within 90 days prior to study of ototoxic medications such as 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, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, or psychiatric disease;
• History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen;
• Current use or within 30 days prior to study of drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes;
• Participation in another investigational drug or device study within 90 days prior to study enrollment;
• Female patients who are pregnant or breastfeeding.

Related Conditions & MeSH terms

• Meniere Disease
• Meniere's Disease

Intervention

Drug:
• SPI-1005
Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.

Locations

Country	Name	City	State
United States	MUSC	Charleston	South Carolina
United States	House Clinic	Los Angeles	California
United States	New York Otology	New York	New York
United States	Northwest Ear	Seattle	Washington
United States	Sound Pharmaceuticals, Inc.	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sound Pharmaceuticals, Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kil J, Harruff EE, Longenecker RJ. Development of ebselen for the treatment of sensorineural hearing loss and tinnitus. Hear Res. 2021 Feb 19:108209. doi: 10.1016/j.heares.2021.108209. [Epub ahead of print] — 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. 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	Safety and tolerability of SPI-1005 using histories, physical exams, and clinical measures.	Incidence of of Treatment-Emergent Adverse Events	7 weeks
Secondary	Plasma Ebselen levels of SPI-1005 before, during, and after 21 days of dosing	Evaluation of potential accumulation of study drug	7 weeks
Secondary	Plasma Selenium levels before, during, and after 21 days of dosing	Evaluation of potential changes in plasma selenium levels	7 weeks
Secondary	Impact on Sensorineural Hearing Loss	Pure Tone Audiometry	7 weeks
Secondary	Impact on Speech Discrimination	Words in Noise Test	7 weeks
Secondary	Impact on Tinnitus	Questionnaire	7 weeks
Secondary	Impact on Vertigo	Questionnaire	7 weeks
Secondary	Pharmacodynamic response	Electrocochleography	7 weeks