Australian Clinical Trials

Broad Health Condition Ear

Specific Health ConditionOther ear disorders

Trial FocusTreatment

Recruitment Details

Recruitment status
Recruiting

Recruitment State
WA

Hospital
Linear Clinical Research - Nedlands

Postcode
6009 - Nedlands

Anticipated date of first participant enrolment13/08/2021

Anticipated date of last participant enrolment30/08/2023

Phase of TrialPhase 1

Has the study received ethics approval?Approved

Trial summary

This is a single-blind, placebo controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics profile of SPT-2101 following a single IT administration. In all study subjects, SPT-2101 or saline will be delivered unilaterally (one ear will remain untreated).
Subjects will enter a 4-week (+/- 2 weeks) lead in period. During this time, subjects will complete a daily patient diary to document baseline vertigo episodes and complete additional laboratory testing.
Subjects will then be further screened based on laboratory results and vertigo diary entries.
Eligible subjects will return for additional baseline assessments and treatment on Day 1.
Cohort 1: A first cohort of subjects (up to 10) will receive SPT-2101 administration in an open-label manner.
Cohort 2: A second cohort of subjects (up to 30) will be randomized 1:1 to either
• Arm 1: Subjects receive IT administration of SPT-2101 or
• Arm 2: Subjects receive a placebo involving IT administration of saline using a sham procedure.
Following study drug administration or sham procedure, subjects will be discharged from the clinic and will return 24 hours post-administration for safety assessments (Day 2). Subjects will have additional follow up visits at Day 8, Day 15, Day 29, Day 57, Day 85, and Day 169.
At Day 85, subjects in the placebo arm who meet prespecified criteria will be eligible to receive SPT-2101 in an open label manner. Placebo subjects who cross over to SPT-2101 treatment will restart the study follow-up schedule at Day 2 following the study schedule for Cohort 1.

Key inclusion criteria

1. Age 18 years to 85 years (inclusive) at the time of screening
2. Provides written informed consent prior to participation in any study procedure
3. Has a diagnosis of unilateral Definite Meniere's disease defined by the Classification Committee of the Bárány Society or the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS)
4. Reports two or more episodes of definitive vertigo (lasting 20 minutes or more) in the month prior to screening
5. Has documented acquired asymmetric sensorineural hearing loss, as reported by the patient or documented by audiometric testing

Minimum age18 Years

Maximum age85 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

1. Ongoing chronic inflammatory or infectious middle ear disease
2. Active infection in the ear, sinuses, or upper respiratory system
3. Current tympanic membrane perforation
4. Active benign paroxysmal positional vertigo (BPPV) symptoms
5. History of superior canal dehiscence