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Nanoparticle
Gold Nanocrystals for Multiple Sclerosis (REPAIR-MS Trial)
Phase 2
Recruiting
Led By Benjamin Greenberg, MD
Research Sponsored by Clene Nanomedicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cohort 1: Stable treatment with natalizumab, defined as a stable dose maintained at the standard infusion interval of 28-days (±5 days) for at least the prior six (6) months
Cohort 1: Clinical diagnosis of Relapsing Multiple Sclerosis (RMS) (meeting McDonald criteria, 2017)
Must not have
Cohort 2: History of AQP4, MOG Ab(+) status, or documented ≥ 3 contiguous segment lesion in the spinal cord
Cohort 1: Patients with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function, or those with low platelet counts (< 150 x 109 per liter) or eosinophilia (absolute eosinophil count of ≥500 eosinophils per microliter) at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 18 weeks
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
Adults aged 18-70 with Multiple Sclerosis (MS) diagnosed within the last 15 years. Participants must have stable MS or be on specific therapies for at least 48 weeks. They should not have had recent relapses, metal implants affected by MRI, significant medical conditions, drug abuse history, pregnancy plans during and post-trial without contraception use, or a gold allergy.
What is being tested?
The REPAIR-MS study is testing CNM-Au8 gold nanocrystals to see if they can improve brain metabolism in MS patients. This involves taking the treatment and having special brain scans called '31P-MRS imaging' over a period of 12 weeks to measure any changes.
What are the potential side effects?
While side effects are not explicitly listed here, typical clinical trial concerns include potential allergic reactions to the gold nanocrystals and issues related to frequent MRI scans such as discomfort or claustrophobia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a stable dose of natalizumab every 28 days for at least 6 months.
Select...
I have been diagnosed with Relapsing Multiple Sclerosis.
Select...
I have been on consistent B-cell therapy or S1P modulator therapy for at least 48 weeks.
Select...
My disability score is 6.5 or less, showing I can walk with some assistance.
Select...
I have been diagnosed with PPMS or nonactive SPMS.
Select...
I am between 18 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of AQP4 or MOG antibody positivity, or a spinal cord lesion spanning 3 or more segments.
Select...
I do not have significant liver or kidney issues, low platelet counts, or high eosinophil levels.
Select...
I am not pregnant, nursing, or planning to become pregnant within 6 months after the trial.
Select...
I am on MS treatment but not using B-cell depleters or S1P modulators.
Select...
I have been treated with MS medications other than natalizumab or have taken clemastine fumarate.
Select...
My symptoms are not due to PPMS or SPMS.
Select...
I am not pregnant, nursing, or planning to become pregnant within 6 months after the trial ends.
Select...
I do not have significant liver or kidney issues, low platelet counts, or high eosinophil levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 18 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The change from baseline to week 12 in CNS metabolic changes, based on 31P-MRS Redox Ratio.
Other study objectives
9-Hole Peg Test
Clinical Global Impression Scale
EDSS
+26 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: 7.5mg CNM-Au8Experimental Treatment1 Intervention
7.5mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
Group II: 60mg CNM-Au8Experimental Treatment1 Intervention
60mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
Group III: 30mg CNM-Au8Experimental Treatment1 Intervention
30mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
Group IV: 15mg CNM-Au8Experimental Treatment1 Intervention
15mg suspension of clean-surfaced, faceted, gold nanocrystals in 120ml of sodium bicarbonate buffered water
Find a Location
Who is running the clinical trial?
Clene NanomedicineLead Sponsor
12 Previous Clinical Trials
769 Total Patients Enrolled
3 Trials studying Multiple Sclerosis
128 Patients Enrolled for Multiple Sclerosis
University of Texas Southwestern Medical CenterOTHER
1,080 Previous Clinical Trials
1,056,259 Total Patients Enrolled
15 Trials studying Multiple Sclerosis
51,664 Patients Enrolled for Multiple Sclerosis
Benjamin Greenberg, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
3 Previous Clinical Trials
119 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have unresolved health issues that could affect my study participation.I have no unresolved health issues that could affect my study participation.I take stimulant meds regularly for over 12 weeks without changing the dose.I have a history of AQP4 or MOG antibody positivity, or a spinal cord lesion spanning 3 or more segments.You have a history of HIV, hepatitis C, or hepatitis B infection. If you have been vaccinated for hepatitis B and have detectable antibodies, you are not excluded unless you test positive for hepatitis surface antigen.I do not have significant liver or kidney issues, low platelet counts, or high eosinophil levels.I am not pregnant, nursing, or planning to become pregnant within 6 months after the trial.I have been on a stable dose of natalizumab every 28 days for at least 6 months.My blood and biochemical tests are stable, even if some results are outside the normal range.If the doctor thinks you might try to hurt yourself, or if you have tried to hurt yourself before, you cannot join this group of the study. If you sometimes think about hurting yourself but don't plan to do it, the doctor will decide if you can join.I have been diagnosed with Relapsing Multiple Sclerosis.You have thoughts of hurting yourself or have tried to hurt yourself in the past.You have metal objects inside your body that could be affected by an MRI scan.I do not have eye conditions causing retinal damage other than MS.You have been involved in another experimental drug study or have taken an experimental drug within the last 12 weeks.You have had an allergic reaction to gold in the past.I have been on consistent B-cell therapy or S1P modulator therapy for at least 48 weeks.I am between 18 and 70 years old.I am on MS treatment but not using B-cell depleters or S1P modulators.Your eyesight is very poor, or you have certain eye conditions that could affect the study results.My disease has not worsened in the last 3 months.My disability score is 6.5 or less, showing I can walk with some assistance.I was diagnosed with MS less than 15 years ago.I have been treated with MS medications other than natalizumab or have taken clemastine fumarate.I have been diagnosed with PPMS or nonactive SPMS.Your blood and other test results need to be within normal limits, and any abnormalities should not be a cause for concern.You are afraid of being in small, enclosed spaces, or you might not be able to finish the MRI scan.You are currently in another research study or taking a medication that is not approved by the government.You have metal objects inside your body that could be affected by an MRI.My symptoms are not due to PPMS or SPMS.I am between 18 and 55 years old.I am not pregnant, nursing, or planning to become pregnant within 6 months after the trial ends.I am not using birth control and do not plan to during the study and for 6 months after.I do not have significant liver or kidney issues, low platelet counts, or high eosinophil levels.I have a history or current infection of HIV, HCV, or HBV, but not just from vaccination.I am not using or cannot use birth control during and 6 months after the study.I needed steroids for a relapse in the last 3 months.If you test positive for drugs or have a history of alcohol abuse, you cannot participate in this group of the study.I have had MS flare-ups or specific brain scan findings in the last 5 years.You are very afraid of small, enclosed spaces or are not likely to be able to complete the MRI scanning procedures.You have tested positive for illegal drugs or have a history of alcohol abuse.You have had an allergic reaction to gold in the past.
Research Study Groups:
This trial has the following groups:- Group 1: 7.5mg CNM-Au8
- Group 2: 15mg CNM-Au8
- Group 3: 30mg CNM-Au8
- Group 4: 60mg 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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