gold nanocrystals for Multiple Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Texas Southwestern, Dallas, TXMultiple Sclerosisgold nanocrystals - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for MS patients who have been diagnosed within the last 15 years. The goal is to see if the drug is safe and effective, and how it affects the brain.

Eligible Conditions
  • Relapsing Remitting Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Through 18 weeks

At 12 Weeks
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of ATP (a, B, y) by subject per dosing group.
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of Extracellular Inorganic Phosphate (Pi(ex))
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of Extracellular inorganic phosphate (Pi(ex)) by subject per dosing group.
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of Intracellular Inorganic Phosphate (Pi(in))
Magnetic Resonance Imaging
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of NAD+
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of NAD+/NADH pool by subject per dosing group.
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of NADH
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of Phosphocreatine (PCr)
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of Phosphocreatine (PCr) by subject per dosing group.
Magnetic Resonance Imaging
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of Uridine Diphosphate Glucose (UDPG)
Mean Change in 31P-MRS Bioenergetic Metabolite CNS Tissue Concentration of Uridine Diphosphate Glucose (UDPG) by subject per dosing group.
Mean Change in 31P-MRS Membrane Component CNS Tissue Concentration of Glycerophosphocholine (GPC)
Mean Change in 31P-MRS Membrane Component CNS Tissue Concentration of Phosphocholine (PC)
Mean Change in 31P-MRS Membrane Component CNS Tissue Concentration of glycerophosphoethanolamine (GPE)
Mean Change in 31P-MRS Membrane Component Tissue Concentration of Phosphoethanolamine (PE)
Mean Change in Axonal Volume Fraction (AVF)
Mean Change in CSF Volume Fraction (F_CSF)
Mean Change in G-Ratio
Mean Change in G-Ration Susceptibility
Mean Change in Myelin Volume Fraction (MVF)
Mean Change in Optical Coherence Tomography (OCT) Retinal Layer of Inner nuclear layer (INL).
Mean Change in Optical Coherence Tomography (OCT) Retinal Layer of Outer nuclear layer (ONL).
Mean Change in Optical Coherence Tomography (OCT) Retinal Layers
Mean Change in Optical Coherence Tomography (OCT) Retinal Layers of ganglion cell + inner plexiform layer (GCIPL)
Retina
Mean Change in Optical Coherence Tomography (OCT) Retinal Nerve Fiber Layer by Peripapillary scan.
Mean Change in Restricted Volume Fraction (F_R)
Mean Change in Symbol Digit Modality Test (SDMT)
The change from baseline to week 12 in CNS metabolic changes, based on 31P-MRS Redox Ratio.
The change from baseline to week 12 in CNS metabolic changes, based on 31P-MRS imaging.
At 12 weeks
9-Hole Peg Test
Clinical Global Impression Scale
EDSS
Low contrast letter acuity by eye
Patient Global Impression Scale
SDMT
Timed 25 foot walk test.
Through 18 weeks
Pharmacodynamic Endpoint
Pharmacokinetic Endpoint

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

6 Treatment Groups

Second dose determined by results of Cohort 1 of CNM-Au8
1 of 6
Dose determined by results of Cohort 1 of CNM-Au8
1 of 6
30mg CNM-Au8
1 of 6
60mg CNM-Au8
1 of 6
7.5mg CNM-Au8
1 of 6
15mg CNM-Au8
1 of 6

Experimental Treatment

30 Total Participants · 6 Treatment Groups

Primary Treatment: gold nanocrystals · No Placebo Group · Phase 2

Second dose determined by results of Cohort 1 of CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug
Dose determined by results of Cohort 1 of CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug
30mg CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug
60mg CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug
7.5mg CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug
15mg CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 18 weeks

Who is running the clinical trial?

Clene NanomedicineLead Sponsor
11 Previous Clinical Trials
864 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
223 Patients Enrolled for Multiple Sclerosis
University of Texas Southwestern Medical CenterOTHER
962 Previous Clinical Trials
1,108,457 Total Patients Enrolled
13 Trials studying Multiple Sclerosis
51,655 Patients Enrolled for Multiple Sclerosis
Benjamin Greenberg, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
2 Previous Clinical Trials
110 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your condition has not worsened or improved significantly in the last three months, according to the doctor's evaluation.
You were diagnosed with Multiple Sclerosis (MS) within the last 15 years.