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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06386822




Registration number
NCT06386822
Ethics application status
Date submitted
22/05/2023
Date registered
21/07/2023

Titles & IDs
Public title
The Development of a System for Measurement of Tremor
Scientific title
The Development of a System for Measurement of Tremor
Secondary ID [1] 0 0
23-1562H
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Essential Tremor 0 0
Dystonia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Devices - Virtual Reality measurement of essential tremor and dystonia

Experimental: Experimental: Virtual Reality & Movement Monitoring - Participants will don the equipment used to measure their tremor and replicate a series of standardized movements to measure their tremor, in and out of the VR platform.


Treatment: Drugs: Placebo
Etrasimod matching placebo tablet taken by mouth, once daily.

Treatment: Devices: Virtual Reality measurement of essential tremor and dystonia
1. The virtual reality (VR) platform, which detects whole-of-body movements. The VR environment is a series of sensors in a room that detect whole body motion and a series of sensors worn by the participant. As well the participant dons VR "goggles" that allows them to "see" a virtual environment in which they can perform the TETRAS.

Within the VR platform, an avatar (an electronic image that represents the participant) is produced in the VR environment, and this will be used to review the participant.
2. Sensors for the detection of wrist, head and voice tremor. The sensors are small devices worn on the wrists and head of the participant and are similar to those used in the VR system. A microphone is attached to the participants to detect voice tremor.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
1. To quantify Essential Tremor and dystonia using a measurement system
Timepoint [1] 0 0
At enrolment. This study is a single assessment conducted at one time point.
Primary outcome [2] 0 0
Proportion of Participants with Endoscopic Response [Substudy A]
Timepoint [2] 0 0
Weeks 14 and 52
Primary outcome [3] 0 0
Proportion of Participants With Endoscopic Response [Substudy 1]
Timepoint [3] 0 0
Week 14
Primary outcome [4] 0 0
Proportion of Participants With Endoscopic Response [Substudy 2]
Timepoint [4] 0 0
Week 14
Primary outcome [5] 0 0
Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]
Timepoint [5] 0 0
Week 14
Primary outcome [6] 0 0
Proportion of Participants With Clinical Remission CDAI [Substudy 3]
Timepoint [6] 0 0
Week 52
Primary outcome [7] 0 0
Proportion of Participants With Endoscopic Response [Substudy 3]
Timepoint [7] 0 0
Week 52
Secondary outcome [1] 0 0
Proportion of Participants With Clinical Remission CDAI [Substudy A]
Timepoint [1] 0 0
Up to Week 66
Secondary outcome [2] 0 0
Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A]
Timepoint [2] 0 0
Baseline to Week 66
Secondary outcome [3] 0 0
Change From Baseline in CDAI Score [Substudy A]
Timepoint [3] 0 0
Baseline to Week 66
Secondary outcome [4] 0 0
Proportion of Participants With Clinical Remission CDAI [Substudy 1]
Timepoint [4] 0 0
Week 14
Secondary outcome [5] 0 0
Proportion of Participants with Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 1]
Timepoint [5] 0 0
Week 14
Secondary outcome [6] 0 0
Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2]
Timepoint [6] 0 0
Week 14
Secondary outcome [7] 0 0
Proportion of Participants With Clinical Response CDAI [Substudy 2]
Timepoint [7] 0 0
Week 14
Secondary outcome [8] 0 0
Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2]
Timepoint [8] 0 0
Week 14
Secondary outcome [9] 0 0
Proportion of Participants With Endoscopic Remission [Substudy 2]
Timepoint [9] 0 0
Week 14
Secondary outcome [10] 0 0
Change from baseline in CD-PRO/SS [Substudy 2]
Timepoint [10] 0 0
Week 14
Secondary outcome [11] 0 0
Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3]
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3]
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3]
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Proportion of Participants With Endoscopic Remission [Substudy 3]
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Proportion of Participants With Clinical Remission PRO2 [Substudy 3]
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Proportion of Participants with Clinical Response or Endoscopic Response [Substudy 3]
Timepoint [16] 0 0
Week 52
Secondary outcome [17] 0 0
Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4]
Timepoint [17] 0 0
Up to Week 208
Secondary outcome [18] 0 0
Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4]
Timepoint [18] 0 0
Up to Week 208
Secondary outcome [19] 0 0
Number and Severity of Adverse Events
Timepoint [19] 0 0
Up to approximately 70 weeks for Substudy A,approximately 24 weeks for Substudy 1 and 2; 42 weeks for Substudy 3; and 212 weeks for Substudy 4

Eligibility
Key inclusion criteria
Inclusion Criteria - Control participants

* Aged 18 to 80 years
* Able to provide informed consent for self
* Able to comply with all study procedures
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria -Control participants

* Any neurological disorder
* Any other non-neurological cause of tremor e.g. medication induced

Inclusion Criteria - ET participants

* Aged 18 to 80 years
* Able to provide informed consent for self
* Clinical diagnosis of ET or ET plus syndrome
* Able to comply with all study procedures

Exclusion Criteria - ET Participants

* Tremor other than ET (e.g. parkinsonian, functional tremor)
* Presence of other movement disorder
* For Deep Brain Stimulation (DBS) participants: unwilling or unable to turn off and on their own stimulator for the duration of the study.

Study design
Purpose of the study
Other
Allocation to intervention
NA
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,NSW,QLD,WA
Recruitment hospital [1] 0 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [2] 0 0
Macquarie Respiratory Services - Macquarie University
Recruitment hospital [3] 0 0
Macquarie University Hospital Clinical Trials - Macquarie University
Recruitment hospital [4] 0 0
Macquarie University Hospital Pharmacy - Macquarie University
Recruitment hospital [5] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [6] 0 0
MQ Health Ophthalmology - Macquarie University
Recruitment hospital [7] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [8] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment hospital [9] 0 0
MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons - Bellfield
Recruitment hospital [10] 0 0
The Northern Hospital - Epping
Recruitment hospital [11] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [12] 0 0
Footscray Hospital - Melbourne
Recruitment hospital [13] 0 0
Vision Eye Institute - Melbourne
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The Royal Melbourne Hospital - Parkville
Recruitment hospital [15] 0 0
Heidelberg Eye Clinic - Rosanna
Recruitment hospital [16] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [17] 0 0
Lions Eye Institute Limited - Nedlands
Recruitment hospital [18] 0 0
The trustee for The RTS Unit Trust trading as Respiratory Testing Services - O'Connor
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
4740 - North Mackay
Recruitment postcode(s) [5] 0 0
3081 - Bellfield
Recruitment postcode(s) [6] 0 0
3076 - Epping
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3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3011 - Melbourne
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3050 - Parkville
Recruitment postcode(s) [10] 0 0
3084 - Rosanna
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
6163 - O'Connor
Recruitment outside Australia
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Leeds
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Norwich

Funding & Sponsors
Primary sponsor type
Other
Name
The Bionics Institute of Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arena is a wholly owned subsidiary of Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Szmulewicz, MBBS PhD
Address 0 0
The Royal Victorian Eye and Ear Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Osborn, BSc
Address 0 0
Country 0 0
Phone 0 0
61396677500
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
None. No findings of direct clinical relevance are expected.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06386822