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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

VISIONMS-LTE Trial Summary

This trial is for people who have already completed another trial, and it is open-label and long-term.

Eligible Conditions
  • Multiple Sclerosis (MS)

VISIONMS-LTE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Best-Corrected Low-Contrast Letter Acuity score.
Therapeutic procedure
Secondary outcome measures
Measure of neurological function assessed by a functional composite responder analysis.
Other outcome measures
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%
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
CNM-Au8
Matching Placebo

VISIONMS-LTE 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
11 Previous Clinical Trials
744 Total Patients Enrolled
2 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients included in this research?

"As this study only includes adults aged 18 to 55, adolescents and seniors are not eligible to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
2020. "A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04626921.
~12 spots leftby Apr 2025
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