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
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
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: DrugDose determined by results of Cohort 1 of CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug30mg CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug60mg CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug7.5mg CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: Drug15mg CNM-Au8
Drug
Experimental Group · 1 Intervention: gold nanocrystals · Intervention Types: DrugTrial 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.