Meniere's Disease Clinical Trial
Official title:
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy of SPI-1005 in Meniere's Disease
Verified date | August 2023 |
Source | Sound Pharmaceuticals, Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Sound Pharmaceuticals, Incorporated |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06001593 -
Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation
|
Phase 1/Phase 2 | |
Completed |
NCT02612337 -
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
|
Phase 3 | |
Completed |
NCT02265393 -
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
|
Phase 2 | |
Completed |
NCT02309099 -
Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
|
N/A | |
Completed |
NCT01412177 -
OTO-104 for the Treatment of Meniere's Disease
|
Phase 2 | |
Terminated |
NCT02717442 -
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
|
Phase 3 | |
Completed |
NCT01084525 -
OTO-104 for Meniere's Disease
|
Phase 1 | |
Terminated |
NCT02530931 -
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Patients With Meniere's Disease
|
Phase 4 | |
Terminated |
NCT02740387 -
Open Label Study of OTO-104 in Subjects With Meniere's Disease
|
Phase 2 | |
Completed |
NCT02158585 -
Study of Lamotrigine to Treat Ménière's Disease
|
Phase 2 | |
Completed |
NCT00145483 -
Sildenafil For Meniere's Disease
|
Phase 4 | |
Suspended |
NCT04026516 -
CAVA: Dizziness Trial
|
N/A | |
Recruiting |
NCT03587701 -
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
|
Phase 2 | |
Completed |
NCT02080312 -
Magnetic Resonance Imaging Evaluation of Inner Ear Pathology Using Intra-Tympanic Contrast Agent
|
N/A | |
Completed |
NCT01454726 -
Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
|
Phase 3 | |
Recruiting |
NCT01099046 -
Stress Management Therapy for Meniere's Disease
|
N/A | |
Completed |
NCT00160238 -
Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy
|
Phase 4 | |
Terminated |
NCT02706730 -
A 6-Month Extension Study of OTO-104 in Meniere's Disease
|
Phase 3 | |
Completed |
NCT02718846 -
Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
|
Phase 4 | |
Completed |
NCT02603081 -
Study to Evaluate SPI-1005 in Adults With Meniere's Disease
|
Phase 1/Phase 2 |