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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04626921




Registration number
NCT04626921
Ethics application status
Date submitted
30/10/2020
Date registered
13/11/2020

Titles & IDs
Public title
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
Scientific title
VISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
Secondary ID [1] 0 0
CNMAu8.201LTE
Universal Trial Number (UTN)
Trial acronym
VISIONMS-LTE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CNM-Au8

Experimental: Active treatment with 30 mg of CNM-Au8 - Highly pure elemental Au nanocrystals are suspended in deionized water buffered with 0.546 mg/mL (6.5 mM) sodium bicarbonate (NaHCO3) concentrated up to 0.5 mg/mL (500 ppm) Au.


Treatment: Drugs: CNM-Au8
30 mg of CNM-Au8
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Best-Corrected Low-Contrast Letter Acuity score.
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Incidence of treatment-emergent AEs throughout the study.
Timepoint [2] 0 0
2 years
Secondary outcome [1] 0 0
Measure of neurological function assessed by a functional composite responder analysis.
Timepoint [1] 0 0
2 years

Eligibility
Key inclusion criteria
* Participants must have completed study CNMAu8.201.
* Able to understand and give written informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Lack of treatment compliance during participation in the CNMAu8.201 (VISIONARY-MS) study.
* Positive pregnancy test.
* Any history of previous malignancy, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix, post documented full resections, with clean margins.
* Based on the Investigator's judgment, any concurrent chronic or acute illness or unstable medical condition that could confound the results of safety assessments, increase risk to the participant, or lead to difficulty complying with the protocol; any untreated or unstable psychiatric disease including depression, bipolar and psychosis.
* Participant is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.

Following clinical and serology sample analysis conducted at the end-of-study visit for CNMAu8.201 (VISIONARY-MS), participants may be removed from this long term extension study if any of the following criteria are met, at the discretion of the Medical Monitor and/or Sponsor's Medical Representative:

* Positive serology for viral hepatitis B and/or C and/or human immunodeficiency virus (HIV).
* Abnormal liver function tests (aspartate aminotransferase [ASAT] or alanine aminotransferase [ALAT] > 2x upper limit of normal range (ULN) or total bilirubin > 2x ULN or alkaline phosphatase (AP) > 3x ULN).
* Participants with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function (e.g., glomerular filtration rate < 40 mL/min [based on creatinine clearance according to Cockcroft-Gault equation]), or those with low platelet counts (<150 x 109 per liter) or eosinophilia (absolute eosinophil count of =500 eosinophils per microliter) at the EOS visit for CNMAu8.201 (Visionary-MS).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/09/2023
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAZVIC
Recruitment hospital [1] 0 0
Sydney Brain Mind Centre - Camperdown
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Menzies Institute for Medical Research - Hobart
Recruitment hospital [5] 0 0
The Alfred Centre Department of Neuroscience - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Clene Nanomedicine
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
George Clinical
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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


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/NCT04626921