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Gold Nanoparticles
CNM-Au8 for Multiple Sclerosis (VISIONMS-LTE Trial)
Phase 2 & 3
Waitlist Available
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 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial continues the treatment with CNM-Au8 for participants from a previous study to support nerve cell health and improve vision and brain functions.
Eligible Conditions
- Multiple Sclerosis (MS)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Best-Corrected Low-Contrast Letter Acuity score.
Therapeutic procedure
Secondary study objectives
Measure of neurological function assessed by a functional composite responder analysis.
Other study objectives
Change in Best Corrected High Contrast Visual Acuity
Change in best corrected Low-Contrast Letter Acuity score for total number of correct letter.
MRI Evaluation of the Mean Percent Cerebral Cortical Change from Baseline
+20 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%
Dysphagia
8%
Urinary tract infection
6%
Tension headache
6%
Cough
6%
Oedema peripheral
5%
Arthralgia
5%
Amyotrophic lateral sclerosis
5%
Vomiting
5%
Skin laceration
5%
Sinusitis
5%
Pruritus
4%
Pulmonary embolism
4%
Decreased Appetite
3%
Respiratory failure
3%
Post-traumatic pain
3%
Depression
2%
Weight Decreased
2%
COVID-19
1%
Sepsis
1%
Syncope
1%
Foot fracture
1%
Chest pain
1%
Failure to thrive
1%
Complication associated with device
1%
Malnutrition
1%
Rib fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
CNM-Au8
Matching Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Active treatment with 30 mg of CNM-Au8Experimental Treatment1 Intervention
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
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
12 Previous Clinical Trials
744 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
103 Patients Enrolled for Multiple Sclerosis
George ClinicalUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant, as confirmed by a pregnancy test.You have had any type of cancer before, except for certain types of skin or cervical cancers that were completely removed.You have a mental health condition that is not being treated or is not stable, such as depression, bipolar disorder, or psychosis.You have tested positive for hepatitis B, hepatitis C, or HIV.Your liver function tests show high levels of certain chemicals, indicating possible liver problems.You have liver or kidney problems that would make it hard to understand any changes in your liver or kidney function.Your blood platelet count is below 150 or you have a high level of eosinophils in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: Active treatment with 30 mg of CNM-Au8
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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