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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 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Side effects data

From 2023 Phase 2 & 3 trial • 161 Patients • NCT04414345
22%
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

CNM-Au8 (Gold Nanoparticles) Clinical Trial Eligibility Overview. Trial Name: NCT04626921 — Phase 2 & 3
Multiple Sclerosis Research Study Groups: Active treatment with 30 mg of CNM-Au8
Multiple Sclerosis Clinical Trial 2023: CNM-Au8 Highlights & Side Effects. Trial Name: NCT04626921 — Phase 2 & 3
CNM-Au8 (Gold Nanoparticles) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04626921 — Phase 2 & 3
~11 spots leftby Nov 2025
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