Update: This post was written several months ago. The Visionary Trial (CMN-Au8) has since been Terminated. Clinicaltrials.gov lists Covid19 as being the reason for termination. I am super bummed too. I am working on an updated blog with currently running clinical trials.
I am not receiving any kind of compensation from any agency Or pharmaceutical company for sharing these trials. I’m just here, searching, and sharing what I find. I do not yet have an in-depth knowledge of these trials, but want to share recruitment information to those also searching. Please confer with your doctor, MS Specialist, and Neurologist, as none of the information in my blogs is intended as medical Advise.
Remyelination has been coined by leading MS Specialists and Researchers, as the holy grail of MS research. The Holy Grail of Remyelination research, the ultimately sought for, healing agent, to reverse damage and take away accrued wounds. I don’t know if you remember Indiana Jones and the Search for the Holy Grail, so I’m inserting a clip. The quest for the Holy Grail of Christ, to confer immortality, but also healing of wounds. Other’s sought it selfishly, but our hero Indiana Jones used it to heal the mortal wounds of his father. There were lavishly ornamented Golden chalices to choose from, but Indiana chose the simple, tarnished cup with an inner golden luster. (Spoiler Alert) It healed his father, Prof. Harry Jones.
So Why am I opening this Remyelination and Restorative clinical trial blog with talk of a classic movie from the late 80s? We talk of the holy grail of MS research being the cup that will restore the myelin, restore the insulating coating on our nerves and perhaps, offer us healing, similar to the fabled chalice. One of the trials I list here, comes from none other than nanocrystaliene gold molecules. A potential holy grail to remyelinate our nerves, may actually be from Gold?! Really? To find out more about the VISIONARY CNM-Au8 (Remember, Au is the elemental symbol for Gold) trial and other restorative trials for Relapsing and Progressive forms of MS. Please read on! I have organized by MS Type (Relapsing or Progressive) and list under each trial link, age restrictions, locations, other qualifying criteria. Remember there are the links to clinicaltrials.gov and these links have information on how to actually sign up for these trials. So if you are interested, please click away. Links will open in a new tab, so if you are also interested in learning about other trials, you will not loose your place in this blog post.
All the information on these clinical trials is not included in this blog, so please click away on those clinicaltrial.gov links for more information about locations, contact information, requirements, and exclusions from each trial
Other Key Clinical Trials in this blog post are the EMBOLD and NeuroVax clinical trials, actively recruiting for Progessive forms of Multiple Sclerosis (PPMS and SPMS). This is so exciting that there are more therapies being investigated. If you are interested in being part of a Clinical Trial and have a form of progressive multiple sclerosis, please check out this section at the end of the article.
Please bear with me. There is a lot of information in this post, because I wanted to cast a wide net, so you will have more chance of finding a trial you qualify for, without having to do too much Cog Fog inducing searching. I apologize if there is any information overload. I have listed SEVEN clinical trials for Multiple Sclerosis, and all have links with more information to apply for participation. Please comment, or email me if you need more help finding a trial you qualify for. My goal with this blog post is to hasten the recruiting process as it can traditionally take a long time for trial locations to find the patients, and the patients to find the right trial locations. I hoping this blog with do at least some good, in simplifying the process to speed along the research. I am planning on going more in depth on some of these trials, so please comment or email if there are trials you want more information on. Please share if there are any trials you know of that I don’t, or if comfortable, please share if you have applied for or are in one of these clinical trials! Thank you so much! 🤞🏼🙏🏼
Relapsing Multiple Sclerosis (RRMS)
Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis (VISIONARY-MS)
“The objective of this trial is to assess the efficacy and safety of CNM-Au8 as a remyelinating treatment for vision-impairing MS lesions in participants who have chronic vision impairment as a result of Relapsing-Remitting Multiple Sclerosis. The primary endpoint is to assess the efficacy and safety of CNM-Au8 as a remyelinating therapy in patients with stable RMS. The secondary endpoint is Change in Functional Composite Responder Analysis Score from Baseline to Week 24.”
(VISIONARY-MS)
Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis (VISIONARY-MS) (Clickable Link to Trial Information)
- “Recruiting ages 18-55
- Must have clinical diagnosis of Relapsing Multiple Sclerosis for no more that 15 years
- “Maximum Best Corrected High Contrast Visual Acuity (BC-HCVA) deficit on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart of 20/200 (6/60 metric) in both eyes.”
- “Best Corrected Low Contrast Letter Acuity (BC-LCLA) (by 2.5% Sloan Chart) must be 20/40 (6/12 metric) (inclusive) or worse in the affected eye and 20/32 (6/9.5 metric) or worse in the fellow eye; and the BC-LCLA must be worse than BC-HCVA for the respective value in both eyes.”
- “Retinal Nerve Fiber Layer (RNFL) thickness ≥ 70 μm.”
- Stable disease activity over the last 6 months”
(VISIONARY-MS)
Locations Actively Recruiting
On clinicaltrials.gov you will find a full list of locations involved in this trial. I am including Recruiting and Not Yet Recruiting locations in this list, but am excluding the terminated and not recruiting locations.
United States
| United States, Maryland | |
| Johns Hopkins University | Not yet recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Nicole Pellegrini 410-614-4551 npelleg1@jhmi.edu | |
| Principal Investigator: Shiv Saidha | |
| United States, Ohio | |
| The Cleveland Clinic | Not yet recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Sadie Coates 216-444-2330 coatess@ccf.org | |
| Principal Investigator: Jeffery Cohen, MD | |
| United States, Texas | |
| UT Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Amy Conger 214-645-8217 amy.conger@utsouthwestern.edu | |
| Principal Investigator: Peter Sguigna | |
| United States, Utah | |
| The University of Utah | Not yet recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Lawanda Esquibel 801-585-7575 Lawanda.Esquibel@hsc.utah.edu |
Australia
| Australia, New South Wales | |
| John Hunter Hospital | Recruiting |
| New Lambton Heights, New South Wales, Australia, 2305 | |
| Contact: Jeannette Lechner-Scott, MD Jeannette.Lechner-Scott@hnehealth.nsw.gov.au | |
| Royal North Shore Hospital | Recruiting |
| St. Leonards, New South Wales, Australia, 2065 | |
| Contact: John Parratt, MD SharpNeurology@outlook.com | |
| Sydney Brain Mind Centre | Recruiting |
| Sydney, New South Wales, Australia | |
| Contact: Heidi Beadnall, MD heidi@sydneyneurology.com | |
| Westmead Hospital | Active, not recruiting |
| Westmead, New South Wales, Australia, 2145 |
| Australia, Queensland | |
| Princess Alexandria Hospital | Recruiting |
| Woolloongabba, Queensland, Australia, 4102 | |
| Contact: stefan Blum, MD Stefan.Blum@health.qld.gov.au | |
| Australia, Tasmania | |
| Menzies Institute for Medical Research | Recruiting |
| Hobart, Tasmania, Australia, 7000 | |
| Contact: Taylor Bruce, MD bruce.taylor@utas.edu.au | |
| Australia, Victoria | |
| Austin Health | Active, not recruiting |
| Heidelberg, Victoria, Australia, 3084 | |
| Alfred Health | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Contact: Anneke van der Walt, MD anneke.vanderwalt@monash.edu |
| Australia | |
| Lyell McEwin Hospital | Active, not recruiting |
| Elizabeth Vale, Australia, 5112 |
Canada Locations
| Canada, British Columbia | |
| University of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada, V6T 1Z3 | |
| Contact: Peggy Law 604 822 1756 peggy.law@ubc.ca | |
| Principal Investigator: Anthony Traboulsee | |
| Canada, Ontario | |
| The Ottowa Hospital | Not yet recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Carol Freedman 613 737 8104 cfreedman@toh.ca | |
| Principal Investigator: Mark Freedman |
For more information on the VISIONARY Trial, sponsored by Clene Nanomedicine, I’m including some more informational links.
CNM-Au8 Seen to Raise Energy Metabolism of Brain in RRMS Trial
Testosterone therapy
TOTEM RRMS (Clickable Link to the Trial information)
The Totem RRMS clinical trial is only recruiting Men because it is investigating if testosterone hormone therapy can spur remyelination in men.
“It has been demonstrated that testosterone can act through neural androgen receptors to promote proliferation and differentiation of oligodendrocyte precursors into mature oligodendrocytes in a cuprizone-induced animal model of demyelination. The rare clinical trials on testosterone are mainly exploratory. Here, we sought to demonstrate an effect of testosterone supplementation in testosterone-deficient patients in a multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial.
The main objective will be to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyzes.
As secondary objectives, we would like to study the impact of testosterone supplementation on other conventional and unconventional MRI parameters and on clinical outcomes (cognition, fatigue, quality of life, impact on work / activity and anxiety / depression).”
TOTEM RRMS
This trial is recruiting Men ages 18-55 in several locations in France. If you are located in France and on Social Heath Care, and have been using Tysabri to treat your MS, the contact information is listed below.
Contact: Laurent D KREMER, MD+33 3 88 12 87 33laurentdaniel.kremer@chru-strasbourg.fr
Contact: Nicolas COLLONGUES, MD+33 3 88 12 87 33nicolas.collongues@chru-strasbourg.fr
Tolervit-MS
The purpose of this study is to determine the safety and tolerability of the intranodal administration of autologous monocyte-derived dendritic cells tolerised with Vitamin-D3 and pulsed with myelin peptides (tolDC-VitD3) in multiple sclerosis patients . To select the most appropriate regime for the development of future therapeutic trials.
To evaluate the preliminary proof of concept by clinical and/or radiological activity and immunological markers.
https://clinicaltrials.gov/ct2/show/NCT02903537
- Recruiting in Spain
- Ages 18-55
- Both RRMS and PPMS (Small 16 participants)
| Hospital Universitari Germans Trias i Pujol | Recruiting |
| Badalona, Barcelona, Spain, 08916 | |
| Contact: Cristina Ramo, MD.PhD +34934978433 cramot.germanstrias@gencat.cat | |
| Contact: Ana M Barriocanal, MD.PhD +34934978488 ambarriocanal@igtp.cat |
Application of ihMT MRI in Multiple Sclerosis
The development of in vivo biomarkers sensitive to myelin disruption represents a major clinical need to be able to monitor the demyelination processes as well as the effect of remyelinating therapies in multiple sclerosis. The investigators recently proposed a technique, derived from the conventional magnetisation transfer (MT): inhomogeneous Magnetisation Transfer (ihMT). In preliminary studies, this simple-to-implement and robust technique has shown great sensitivity for evaluating the demyelination processes. The goal of the project is to evaluate the ability of ihMT to measure and describe the spontaneous demyelination and remyelination processes involved in active lesions in a population of patients with MS at the the disease onset.
https://clinicaltrials.gov/ct2/show/NCT03600779
Application of ihMT MRI in Multiple Sclerosis (ihMTMS)
- Ages 18-45
- Male and Female Participants
- Diagnosed with RRMS for less than five years
Contacts
| Contact: JEAN PELLETIER, MD | +33 491388204 | Jean.PELLETIER@ap-hm.fr |
Locations
| France | |
| Assistance Publique Des Hotipaux de Marseille | Recruiting |
| Marseille, Paca, France, 13354 | |
| Contact: JEAN PELLETIER, MD +33 491388204 Jean.PELLETIER@ap-hm.fr |
Aerobic Exercise to Promote Remyelination
This is a clinical trial to determine the feasibility of a stationary aerobic cycling intervention and explore if aerobic exercise independently promotes remyelination in people with multiple sclerosis (MS).
https://clinicaltrials.gov/ct2/show/NCT04539002
Aerobic Exercise to Promote Remyelination
- Physician-confirmed diagnosis of MS
- 18-64 years old
- English-speaking
Contacts
| Contact: Lindsey B Wooliscroft, MD, MS | 503-494-5759 | wooliscr@ohsu.edu | |
| Contact: Michelle Cameron, MD, PT, MCR | 503-494-5759 | cameromi@ohsu.edu |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Lindsey Wooliscroft, MD, MS 503-494-5759 wooliscr@ohsu.edu |
Progressive MS Trials (PPMS-SPMS)
I apologize for putting these critical studies for Progress MS last in the blog; but no wait, actually, I will argue I saved the best for last! If you are interested in these two trials, please get in contact today. The first link for the Embold Study is a qualifying recruitment questionnaire. It’s a large study, so it is best to fill out the questionnaire, to see if you qualify. I did, even though I didn’t qualify and got called by the study to ask further qualifying questions.
Embold Study
The purpose of this study is to evaluate the safety and tolerability of ATA188 as a monotherapy in Parts 1 and 2, to determine the recommended Part 2 dose (RP2D) of ATA188 as monotherapy in Part 1, and to evaluate the effect of ATA188 treatment on clinical disability, as assessed by sustained Expanded Disability Status Scale (EDSS) improvement at 12 months in Part 2 in participants with progressive forms of multiple sclerosis (MS) (primary progressive multiple sclerosis [PPMS] and secondary progressive multiple sclerosis [SPMS]).
Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis (EMBOLD)
Embold Study Eligibility Questionnaire– Click Here to Apply for the Embold Trial!
The Embold Study of ATA 188 is a combined Phase 1 Clincial Trial, progressing to Phase 2 clinical trial to rate the safety and effectiveness of ATA 188 in treating Progressive Forms of Multiple Sclerosis. This trial seems to be filling up fast, as the need for an effective treatment for progressive forms of MS is critical.
ATA 188 is an Epstein-Barr Virus targeting medication. Once it is studied in Progressive forms of MS, they may also begin trials for RMS.
I’m sorry for being so brief about this trial, but as it is such a critical need for so many people with progressive forms of Multiple Scerlosis, I wanted to get this blog out to anyone who is looking and still interested in participating in this trial. I received a call from a recruiter for the trial this weekend, but I as I am not diagnosed with a progressive form of MS I do not qualify for the trial. The recruiter shared that the Fullerton, CA spots are almost full! Thinks have been crazy this week, as is common in my life (Mom with MS and two little kids) and I’ve felt a pressing need to get this information out there. A lot of information has been shared about this trial by members of the Facebook Group I created; Remyelination: Reaching for the Possible in MS. I have also heard from a few friends who are hopeful in participating in the trial. If you want more information, please join the group. I am also including more links to research about ATA 188 below.
ATA 188- Arata Biotherapeutics
“Inclusion Criteria:
- For Part 2: 18 to < 61 years of age
- For Part 2: Current diagnosis of a progressive form of MS as defined by the 2017 Revised McDonald criteria
- For Part 2: EDSS scores of 3.0 to 6.5
- Positive EBV serology
- For Part 1 (recruitment completed): 18 to < 66 years of age
- For Part 1 (recruitment completed): History of progressive forms of MS as defined by the 2010 Revised McDonald criteria for the diagnosis of MS
- For Part 1 (recruitment completed): EDSS scores of 3.0 to 7.0″
Recruiting in multiple locations in the United States and Austraila. Please fill out the Embold Recruiting Questionnaire or see the the locations listed in the clinicaltrials.gov listing.
Neurovax for SPMS
Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund’s Adjuvant ( I F A) placebo. 200 subjects with Secondary Progressive SPMS
A Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
- Subject is between 18 and 50 years of age, inclusive.
- Diagnosis of SPMS
- EDSS Score greater than 3.5
- “Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening.”
Multiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system (CNS) characterized by neuroinflammation, neurodegeneration and impaired repair mechanisms that lead to neurological disability. The crux of MS is the patient’s own immune cells attacking self-antigens in the CNS, namely the myelin sheath that protects nerve cells of the brain and spinal cord. Restoring antigen-specific tolerance via therapeutic vaccination is an innovative and exciting approach in MS therapy. Indeed, leveraging the body’s attempt to prevent autoimmunity, i.e., tolerization, focuses on the underlying cause of the disease and could be the key to solving neuroinflammation. In this perspective, antigen-specific vaccination targets only the detrimental and aberrant immune response against the specific disease-associated antigen(s) involved while retaining the capacity of the immune system to respond to unrelated antigens. We review the experimental approaches of tolerance-inducing vaccination in relapsing and progressive forms of MS that have reached the clinical development phase, including vaccination with autologous T cells, autologous tolerogenic dendritic cells, T cell receptor peptide vaccination, altered peptide ligand, ATX-MS-1467, cluster of differentiation (CD)-206-targeted liposomal myelin basic protein peptides and DNA vaccination. Failures, successes and future directions are discussed.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5976685/
So, here’s hoping. With seven clinical trials listed here, let’s hope when we meet back here two years down the road, we are much closer to the Holy Grail of Remyelination Research. Two years ago, I signed up to participate in a Remyelination Trial for the drug Elezanumab, which unfortunately did not meet the trial endpoints. However, the trial put me on this path of looking, searching for the next trial. I was on the Placebo, but I saw so many benefits in my health and well being. I built a community around myself and I hope you will join, as we lean on one another, for support in the coming years. Please, if you are considering joining a trial share with us, or join Remyelination: Reaching for the Possible in Multiple Sclerosis. Building that group, gave me so much peace of mind while I was dealing with some uncertainties during the trial. The support of other like minded individuals was invaluable. I will leave you here, because I need to publish, and take care of my kids. 😊 May God be with you til we meet again! 🙏🏼🧡
ms GUIDED Bits 