Pick of the Week’s News: Clinical Trial, Collaboration, Oral DMTs, Resilience, Cannabis

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Here’s my Pick of the Week’s News as published by Multiple Sclerosis News Today.

MS Patients with Spasticity Needed for Study of Extended-release Baclofen Capsules

Now here’s a rare chance to get involved in a clinical trial – as long as you have MS and experience some form of spasticity.

A new clinical trial evaluating the effectiveness of extended-release baclofen capsules in relieving spasticity related to multiple sclerosis (MS) is calling for 135 people with any form of the disease. The study, taking place in six U.S. states, is sponsored by Sun Pharma, the drug’s developer.

Baclofen, an approved MS treatment available in different forms, acts as a muscle relaxer and an antispastic agent. As an extended-release treatment, Baclofen GRS distributes the drug’s active ingredients over time in a patient’s body, possibly allowing for less frequent dosing than is now common.

To take part, patients must be 18 or older and diagnosed with any form of MS, have a known history of spasticity, and already may be using baclofen in its current approved formulations.

Participants should have no clinical history of hypersensitivity to baclofen and no previous treatment with intrathecal baclofen, a method that delivers the drug directly to the intrathecal space (area of the spine) via a surgically implanted infusion pump and catheter.

Trial investigators will randomize participants to oral daily treatment with extended-release high-dose baclofen, low-dose baclofen, or placebo, for about 25 days. The trial, called Basis, lasts for 46 days, and three clinic visits will be required.

Doctor’s offices taking part in the study will be in these cities: Long Beach and San Diego, Calif.; Aurora, Colo.; Jacksonville, Miami, Miami Springs, Orlando, and Tampa, Fla.; Charlotte, N.C.; Cleveland, Ohio; and Richland, Wash.

More information about this trial, and how to participate, can be found on the trial’s website at www.basisstudy.com.

Siemens Healthineers and Biogen to Enhance MRI’s Ability to Help MS Patients

Is it me or is this encouraging? The fact that two companies with different expertise are getting together to try to develop new aids to improve MS care.

Siemens Healthineers and Biogen are to collaborate to develop new magnetic resonance imaging (MRI) applications that can quantify key markers of multiple sclerosis.

“By bringing together the shared expertise of both Siemens Healthineers and Biogen in imaging and neurology, respectively, we seek to develop new measurement tools that meet the particular technical challenges of MS,” Christoph Zindel, senior vice president of MRI at Siemens Healthineers, said in a press release.

“Our shared goal is to create a solution that can be integrated into the existing radiology workflow, so it can become a seamless part of routine care – delivering new and valuable information to treating neurologists without increasing the cost or burden on the healthcare system,” Zindel added.

Many physicians use MRI to diagnose and track MS. It not only measures disease activity but also monitors response to therapies.

In related news, if you would like to know more about MRIs and what to ask your doctor about them, read Debi Wilson’s column “Know which questions to ask your neurologist about MRIs.” Debi was diagnosed with primary progressive MS in 2010. Since then, she has written to help others fight the disease.

Reports on MS Treatment Market Show Growing Shift to Oral Therapies

Although not being a fan of any type of disease modifying therapies (DMTs), because of the side effects involved, I do recognize their value. I also find it interesting that oral therapies are gaining in popularity over other types.

The multiple sclerosis market shifted during 2016, with oral disease-modifying therapies capturing a greater share and Sanofi-Genzyme’s Aubagio (teriflunomide) being poised for growth, according to a press release from Spherix Global Insights.

The conclusions were included in the company’s “RealTime Dynamix: Multiple Sclerosis,” a quarterly report based on responses from more than 100 neurologists actively treating MS patients.

According to the report, oral DMTs secured a significantly greater share of the MS market by the end of 2016 than in 2015, with Biogen’s Tecfidera (dimethyl fumarate) leading the way. But forecasts are favorable for Aubagio, a pyrimidine synthesis inhibitor approved for use by the U.S. Food and Drug Administration (FDA). It is designed to reduce MS flares by preventing specific immune cells from functioning.

Teva’s Copaxone (glatiramer acetate) is still leading among injectable drugs, the report said, but it is facing competition from Sandoz’s Glatopa (glatiramer acetate), the first generic DMT to enter the MS market.

The neurologists said Copaxone use has declined in the past three months as Glatopa’s user base has expanded, but according to the report, some patients and physicians are reluctant to try the generic. Doctors are more willing to prescribe Glatopa for patients new to DMTs than to switch from Copaxone or other agents, the report said.

Resilience Linked to Social Satisfaction and Quality of Life, but Not Physical Function in MS, Other Diseases

Really scratching my head on this one. How can resilience can be associated with satisfaction with social skills and quality of life, but not with physical function?

But, according to a recent survey, that is exactly how resilience, the ability of a person to cope with change and solve problems, works in patients with multiple sclerosis and other chronic diseases.

The article with the findings is titled “Resilience and function in adults with physical disabilities: an observational study,” and was published in the Archives of Physical Medicine and Rehabilitation.

MS can have a significant impact on emotions, not only because of the unpredictability of the disease course, but also because it affects parts of the brain that control mood. Therefore, understanding factors that promote resilience may help people with MS cope and adapt to unpredictable health changes.

To determine if resilience was linked with satisfaction with social roles, physical functioning, and quality of life, Samuel Battalio and colleagues at the University of Washington examined information from 1,574 people with MS and other chronic conditions, including muscular dystrophy, post poliomyelitis syndrome, or spinal cord injury.

On its website, the National Multiple Sclerosis Society provides a resource for people with MS that promotes resilience through learning skills and habits and that may help patients “thrive in the face of adversity.” More information can be found here.

Majority of Irish Physicians Approve of Cannabis as MS Treatment, Survey Finds

This is a downright bizarre conundrum. While most Irish general practitioners are against decriminalizing cannabis use, many, especially those over age 50, say it can be useful for treating multiple sclerosis and other medical conditions.

The results are detailed a new study, “Irish general practitioner attitudes toward decriminalisation and medical use of cannabis: results from a national survey,” published in the Harm Reduction Journal.

Debate on decriminalizing cannabis and its medical use is raging in Ireland. Allowing its use for medical purposes would involve physicians prescribing it, so researchers at Waterford Institute of Technology performed a survey to assess support for therapeutic cannabis.

“The majority of Irish GPs do not support the present Irish governmental drug policy of decriminalisation of cannabis but do support the legalisation of cannabis for therapeutic purposes,” the team concluded. “Male GPs and those with higher levels of addiction training are more likely to support a more liberal drug policy approach to cannabis for personal use. … Ongoing research into the health and other effects of drug policy changes on cannabis use is required.”

The timing of the study coincided with the publication of an extensive U.S. report, showing that cannabis-related compounds may have a role in treating MS-related spasticity.


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