SPI-1005 for the Treatment of Patients With Meniere's Disease

NCT03325790 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SPI-1005-251
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Meniere's Disease

Keywords

Meniere's disease; Hearing Loss; Vertigo; Tinnitus; Ebselen; Pharmacokinetics; Safety; Efficacy; Speech

Outcome Measures

Primary Outcomes (6)

• 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

• Efficacy of SPI-1005 on Hearing Loss

  Improvement in sensorineural hearing loss from baseline using Pure Tone Audiometry

  8 weeks

• 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

• 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

• 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

• 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 Outcomes (1)

• Trough Plasma Concentration of SPI-1005

  2 weeks, 4 weeks, 8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

200mg SPI-1005 twice daily (BID)

EXPERIMENTAL

200mg SPI-1005 BID

Drug: 200mg SPI-1005 BID

400mg SPI-1005 BID

EXPERIMENTAL

400mg SPI-1005 BID

Drug: 400mg SPI-1005 BID

Interventions

200mg SPI-1005 BID DRUG

Active: low dose

Also known as: ebselen

200mg SPI-1005 twice daily (BID)

400mg SPI-1005 BID DRUG

Active: high dose

Also known as: ebselen

400mg SPI-1005 BID

Placebo OTHER

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sound Pharmaceuticals, Incorporated: lead

Study Sites (13)

Ccent/Cccr

Fresno, California, 93720, United States

Location

UCSD

San Diego, California, 92093, United States

Location

UCSF

San Francisco, California, 94115, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

UMiami

Miami, Florida, 33146, United States

Location

KUMC

Kansas City, Kansas, 66160, United States

Location

Advanced ENT & Allergy

Louisville, Kentucky, 40207, United States

Location

ENT and Allergy Associates, LLP

New York, New York, 10017, United States

Location

CEENTA

Charlotte, North Carolina, 28210, United States

Location

TJU

Philadelphia, Pennsylvania, 19144, United States

Location

MUSC

Charleston, South Carolina, 29425, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Northwest Ear, Inc.

Seattle, Washington, 98104, United States

Location

Related Publications (5)

• 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.

  PMID: 17030476 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28716314 BACKGROUND

• 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.

  PMID: 33678494 BACKGROUND

• 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.

  PMID: 34510123 DERIVED

Related Links

• Sound Pharmaceuticals, Inc.

MeSH Terms

Conditions

Meniere Disease; Hearing Loss; Vertigo; Tinnitus; Speech

Interventions

ebselen

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vestibular Diseases; Verbal Behavior; Communication; Behavior

Results Point of Contact

• Title: Dr. Jonathan Kil
• Organization: Sound Pharmaceuticals, Inc.

info@soundpharma.com

206-634-2559

Study Officials

• Jonathan Kil, MD

  Sound Pharmaceuticals, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: DOUBLE-BLIND
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 30, 2017
• Study Start: September 28, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: September 18, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)