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
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.
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. ;
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 |