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Nanoparticle
CNM-Au8 for Multiple Sclerosis (VISIONARY-MS Trial)
Phase 2
Waitlist Available
Led By Heidi Beadnall, MD
Research Sponsored by Clene Nanomedicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 12 weeks following the 6-month primary endpoint, up to 48-weeks
Awards & highlights
VISIONARY-MS Trial Summary
This trial will assess how effective and safe CNM-Au8 is as a treatment for MS-related vision problems in people who have had these problems for a while.
Eligible Conditions
- Multiple Sclerosis
- Optic Neuropathy
- Optic Neuritis
VISIONARY-MS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 12 weeks following the 6-month primary endpoint, up to 48-weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 12 weeks following the 6-month primary endpoint, up to 48-weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measures of Visual Function
Secondary outcome measures
Other Measures of Neurological Function
Other outcome measures
9-Hole Peg Test
Change in Best Corrected Low-Contrast Letter Acuity (BC-LCLA)
Change in Best High Contrast Visual Acuity Testing (HCVA)
+19 moreSide effects data
From 2023 Phase 2 & 3 trial • 161 Patients • NCT0441434522%
Fall
20%
Muscular weakness
19%
Diarrhoea
14%
Nausea
14%
Constipation
14%
Headache
13%
Dysarthria
12%
Neuromyopathy
11%
Fatigue
11%
Dyspnoea
8%
Urinary tract infection
8%
Dysphagia
6%
Cough
6%
Tension headache
6%
Oedema peripheral
5%
Sinusitis
5%
Amyotrophic lateral sclerosis
5%
Arthralgia
5%
Pruritus
5%
Vomiting
5%
Skin laceration
4%
Pulmonary embolism
4%
Decreased Appetite
3%
Depression
3%
Respiratory failure
3%
Post-traumatic pain
2%
COVID-19
2%
Weight Decreased
1%
Malnutrition
1%
Sepsis
1%
Syncope
1%
Complication associated with device
1%
Failure to thrive
1%
Foot fracture
1%
Chest pain
1%
Rib fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Matching Placebo
CNM-Au8
VISIONARY-MS Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: 30mg CNM-Au8Experimental Treatment1 Intervention
30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water
Group II: 15mg CNM-Au8Experimental Treatment1 Intervention
15mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water
Group III: PlaceboPlacebo Group1 Intervention
The matched placebo to be used in this study will consist of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatments.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CNM-Au8
2019
Completed Phase 3
~350
Find a Location
Who is running the clinical trial?
Clene NanomedicineLead Sponsor
11 Previous Clinical Trials
726 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
85 Patients Enrolled for Multiple Sclerosis
Clene Australia Pty LtdUNKNOWN
1 Previous Clinical Trials
45 Total Patients Enrolled
Heidi Beadnall, MDPrincipal InvestigatorUniversity of Sydney
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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