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Archive for the month “April, 2016”

Antihistamine Shows Evidence of Stimulating Myelin Repair in Small Phase II MS Study – More studies needed before the full benefits and risks of this approach can be verified

Summary

  • In a small, phase II clinical trial, the oral antihistamine clemastine modestly improved the transmission of electrical signals in the optic nerve in participants with MS who had optic nerve damage.
  • The improved transmission indicates that nerve-insulating myelin was repaired along the nerve pathways.
  • Clemastine is an over-the-counter allergy medication. Doses in this trial exceeded the maximum recommended for over-the-counter use. Clemastine affects a range of targets in the body, and involves the risk for side effects, particularly at increased dosages.
  • This team is planning an additional trial to further determine the safety and effectiveness of clemastine, as well as studies to identify compounds that may enhance myelin repair and cause fewer side effects.
  • Clemastine was identified as having possible myelin-repairing properties through innovative preclinical research conducted by National MS Society-funded Jonah Chan, PhD, who went on to become first recipient of the Barancik Prize for Innovation in MS Research for this pioneering work.
  • Preliminary results will be presented by the clinical trial’s lead investigator Ari Green, MD (University of California, San Francisco), at the annual meeting of the American Academy of Neurology being held in Vancouver, Canada, April 15 to 21.

Background: In MS, the immune system attacks and destroys myelin, the fatty substance that surrounds and protects the nerve fibers, and the nerve fibers can also be damaged. Current therapies are largely aimed at dampening the immune attacks. However, a therapy that repairs damage to myelin and nerve fibers is also necessary.
A team at the University of California, San Francisco led by National MS Society-funded Harry Weaver Neuroscience Scholar Jonah Chan, PhD, invented a new micropillar technology to rapidly identify compounds that stimulate the regrowth of myelin. The team initiated a screen using this technology, testing a library of 1000 drugs already approved by the FDA for other conditions for their ability to promote the development of myelin-making cells and wrapping of myelin around the micropillars. Clemastine, an oral antihistamine used to treat allergy symptoms, was identified through this process. Dr. Chan was the first recipient of the Barancik Prize for Innovation in MS Research for this pioneering work.

The Clinical Trial: Ari Green, MD, led the team conducting the clinical trial. They administered oral clemastine or inactive placebo twice daily to 50 people with MS and optic nerve damage for 150 days. For the first three months of the study, people were given either clemastine or a placebo, and for the second two months, those initially given clemastine received the placebo and vice-versa. Tests were performed before and after treatment that measured visual evoked potentials. Visual evoked potentials measure transmission of electric signals along optic nerve pathways in response to stimulation. Delays in this transmission occur when the myelin is damaged and if these delays are reduced, it is an indication that myelin repair is occurring along the nerve pathways. (Participants had significant delays in transmission in at least one eye.)

Delays in visual evoked potential were reduced by 1.9 milliseconds per eye, a statistically significant result. The results hinted at a reduction in vision impairment as well, but it did not reach statistical significance. Fatigue increased mildly in participants taking clemastine.

Clemastine is an over-the-counter allergy medication. Doses in this trial exceeded the maximum recommended for over-the-counter use. Also, clemastine affects a range of targets in the body, and involves the risk for side effects, particularly at increased dosages.

Dr. Green cautions that more research with larger numbers of people is needed before doctors can recommend clemastine as a treatment for people with MS. This team is planning an additional trial to further determine the safety and effectiveness of clemastine, as well as studies to identify compounds that may enhance myelin repair and cause fewer side effects.

Drs. Green and Chan both received Society funding to launch their early careers as independent researchers focused on MS, including Harry Weaver Neuroscience Scholar Awards.

Comment: “This preliminary report is exciting, and we look forward to seeing the full results of this clinical trial of clemastine presented and then published,” says Bruce Bebo, PhD, Executive Vice President, Research at the National MS Society. “Finding a way to repair nervous system damage to restore function to people with MS is a very high research priority.”

The 2016 Annual Meeting of the American Academy of Neurology will take place in Vancouver, BC, Canada, April 15-21. The National MS Society will be providing reports summarizing studies. Anyone can get a preview of the technical summaries, or abstracts, of presentations to be given at the meeting at this link, free of charge. 

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Study finds greater role for environment in MS

Environmental factors may be playing a much greater role in the onset of multiple sclerosis than previously realized, according to early research led by Queen Mary University of London and Barts Health NHS Trust. The theory is based on new findings showing that Black people and South Asians in east London have a higher prevalence of MS compared to those groups in their ancestral countries, indicating a strong environmental influence on the disease that could be driving higher MS rates in London.

The researchers, led by Dr. Klaus Schmierer, used electronic records from general practices in four east London boroughs (Tower Hamlets, Newham, Hackney and City of London) which were reviewed for the number of MS-diagnosed patients, grouped by ethnicity. What they found was that MS appeared to be several times more prevalent among African people and South Asians living in London compared to those groups living in their ancestral territory. While prevalence differences could be explained by fewer MS diagnoses occurring in less resourced countries, the authors said it is unlikely to explain the gulf in prevalence between these territories. They said that an alternative, or additional, explanation would be increased exposure in the UK to environmental agents or behaviors that facilitate the development of MS.

Lead author Schmierer said, “MS is a disease where genetic ancestry and environmental factors play a role, however to what degree these two aspects are driving the risk of developing MS remains unknown. We found that people of Asian and African extraction in London are far more likely to have MS than people of the same ethnicity living in their ancestral countries. Our early results suggest that environmental factors play a pivotal role in the risk of developing MS, while the individual genetic backdrop may be of lesser importance.”

The study was published in Multiple Sclerosis Journal.

How Do You Weigh the Risks and Benefits of MS Treatments? Take a Survey Developed by Researchers Funded by the National MS Society

Summary: Investigators want to know how people living with MS weigh risks against benefits when choosing MS therapies. This 20-minute survey is funded by the National MS Society, and was developed by Robert Fox, MD, and colleagues at the Cleveland Clinic and the MS patient registry NARCOMS.

Click Here to participate in this survey.

Rationale: Although the effectiveness and risks of MS therapies are well-defined, relatively little is known about how these benefits and risks are perceived and evaluated by people with MS. This benefit/risk trade-off is important for clinicians, industry, and regulators to understand when considering which therapies to develop, approve for use, and recommend. For these reasons, the Society released a targeted request for proposals on this topic. Dr. Fox and colleagues were awarded a Health Care Policy & Delivery Research Contract to administer a large-scale survey regarding preferences related to various benefits/risks of MS therapies. They are looking for patterns of how people weigh risks and benefits based on their health status and other factors.

Goal: The results should provide a deeper understanding of various perspectives concerning risks and benefits of MS therapies among the various stakeholders involved in the development and use of MS therapies: people with MS and their care partners, clinicians, industry, and regulators such as the U.S. Food and Drug Administration.

Eligibility and Details: All people who have MS are invited to participate. The survey has a series of questions related to MS, MS therapies, and other personal characteristics; several clinical scenarios accompanied by a series of questions related to your willingness to take risks in each scenario; and questions about how you think people with MS should be involved in the government’s review of new MS therapies. The survey should take about 20 minutes to complete.

Click Here to participate in this survey

If you have questions about the survey, please contact MSregistry@narcoms.org, or 1-800-253-7884.

Read more about NARCOMS.

 

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