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Trial registered on ANZCTR


Registration number
ACTRN12621000964819
Ethics application status
Approved
Date submitted
3/06/2021
Date registered
23/07/2021
Date last updated
22/04/2024
Date data sharing statement initially provided
23/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 1 Study of SPT-2101 Given as a Single Intratympanic Injection in Subjects with Unilateral Meniere's Disease
Scientific title
A Prospective, Placebo Controlled, Single-Blind Phase 1 Study of SPT-2101 Given as a Single Intratympanic Injection in Subjects with Unilateral Meniere's Disease (SPT-2101 Safety in Meniere’s Disease Study)
Secondary ID [1] 304238 0
SPT210101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unilateral Meniere's Disease 321940 0
Condition category
Condition code
Ear 319671 319671 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
SPT-2101 is an investigational drug designed for intratympanic (IT) administration. It is composed of a chemically crosslinked hydrogel containing a suspension of dexamethasone.
Topical anesthetic will be applied to the subject’s ear drum and/or ear canal approximately 30 minutes prior to planned study drug administration, or until therapeutic effect is achieved. SPT-2101 will be delivered to the middle ear via IT administration by an ENT otolaryngologist under direct visualization.
The dose level planned is 3 mg of dexamethasone to be administered in a volume of 50 microliter of SPT-2101 containing 6% dexamethasone as a single dose with 24 weeks of post-administration follow-up.
An IT injection of 50 µL of sterile isotonic saline will be performed. The study drug will be prepared on site by study personal as per the Instructions for Use.
Intervention code [1] 320570 0
Treatment: Drugs
Comparator / control treatment
Sham control group.
Participants randomized to the Sham control group will receive a placebo involving
intratympanic (IT) administration of sterile isotonic saline (0.9% (w/v) sodium chloride) using a sham procedure. Participants will be discharged from the clinic and will return 24 hours post-administration for safety assessments (Day 2). Participants will have additional follow up visits at Day 8, Day 15, Day 29, Day 57, Day 85, and Day 169.
Control group
Placebo

Outcomes
Primary outcome [1] 327544 0
To evaluate the safety and tolerability of a single intratympanic (IT) injection of SPT-2101 through targeted physical examination of Head, Eyes, Ears, Nose, and Throat (HEENT) in subjects with unilateral Meniere’s Disease
Timepoint [1] 327544 0
Screening period that is targeted at 4 weeks prior to Day 1; Day 1, Day 2, Day 8, Day 15, Day 29, Day 57, Day 85 and Day 169 post-intervention administration
Secondary outcome [1] 395619 0
To assess the pharmacokinetics of SPT-2101 in subjects with unilateral Meniere’s Disease.
Plasma samples will be collected at various times post-treatment for pharmacokinetics assessment.
The following parameter is used for evaluation during PK assessments: maximum concentration (Tmax) and area under the curve (AUC)
Timepoint [1] 395619 0
Day 0, Day 2, Day 8, Day 15, Day 29, Day 57, Day 85 and Day 169 post intervention administration

Eligibility
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. Self-reports active, definitive vertigo (lasting 20 minutes or more) in the 3 months prior to screening and records 2 or more Definitive Vertigo Days in the lead-in period.
5. Has documented acquired asymmetric sensorineural hearing loss, as reported by the patient or documented by audiometric testing
Minimum age
18 Years
Maximum age
85 Years
Sex
Both 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, including ventilation tube, in the affected ear.
4. Active benign paroxysmal positional vertigo (BPPV) symptoms
5. History of superior canal dehiscence

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A master randomization list will be prepared using a statistical software package by a biostatistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/08/2021
Actual
11/10/2021
Date of last participant enrolment
Anticipated
28/06/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
40
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
Recruitment hospital [1] 19466 0
Linear Clinical Research - Nedlands
Recruitment hospital [2] 26466 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 26467 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [4] 26468 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 34058 0
6009 - Nedlands
Recruitment postcode(s) [2] 42446 0
5042 - Bedford Park
Recruitment postcode(s) [3] 42447 0
3002 - East Melbourne
Recruitment postcode(s) [4] 42448 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 308615 0
Commercial sector/Industry
Name [1] 308615 0
Spiral Therapeutics, Inc.
Country [1] 308615 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Spiral Therapeutics Australia Pty Ltd
Address
58 Gipps Street, Collingwood, 3066 Vic, Australia
Country
Australia
Secondary sponsor category [1] 309484 0
None
Name [1] 309484 0
Address [1] 309484 0
Country [1] 309484 0
Other collaborator category [1] 281785 0
Commercial sector/Industry
Name [1] 281785 0
Novotech (Australia) Pty Limited
Address [1] 281785 0
Level 3, 235 Pyrmont Street, Pyrmont, NSW 2009
Country [1] 281785 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308547 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 308547 0
123 Glen Osmond Road, Eastwood, South Australia, 5063
Ethics committee country [1] 308547 0
Australia
Date submitted for ethics approval [1] 308547 0
13/01/2021
Approval date [1] 308547 0
18/02/2021
Ethics approval number [1] 308547 0
Ethics committee name [2] 315176 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [2] 315176 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [2] 315176 0
Australia
Date submitted for ethics approval [2] 315176 0
20/12/2022
Approval date [2] 315176 0
21/09/2023
Ethics approval number [2] 315176 0
HREC 280/22

Summary
Brief summary
This is a single-blind, placebo controlled, single-dose study to evaluate the safety, tolerability, and PK 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111090 0
Dr Jafri Kuthubutheen
Address 111090 0
Linear Clinical Research, Level 1, B Block, Hospital Ave, Nedlands, Western Australia, 6009
Country 111090 0
Australia
Phone 111090 0
+61 089367 8377
Fax 111090 0
Email 111090 0
[email protected]
Contact person for public queries
Name 111091 0
Jafri Kuthubutheen
Address 111091 0
Linear Clinical Research, Level 1, B Block, Hospital Ave, Nedlands, Western Australia, 6009
Country 111091 0
Australia
Phone 111091 0
+61 089367 8377
Fax 111091 0
Email 111091 0
[email protected]
Contact person for scientific queries
Name 111092 0
Charles Limb
Address 111092 0
Spiral Therapeutics, Inc. 1000 Marina Blvd., Suite 105 Brisbane, CA 94005, USA
Country 111092 0
United States of America
Phone 111092 0
+16504530893
Fax 111092 0
Email 111092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIProtection of lipopolysaccharide-induced otic injury by a single dose administration of a novel dexamethasone formulation2023https://doi.org/10.1186/s41231-023-00156-6
N.B. These documents automatically identified may not have been verified by the study sponsor.