A Guide To Multiple Sclerosis (MS) Clinical Trials

Match to Multiple Sclerosis Clinical Trials

What Is Multiple Sclerosis (MS)?

Multiple sclerosis (MS) is a disease affecting the central nervous system that causes disruption in the flow of information between the brain and the rest of the body.  Essentially, in a multiple sclerosis patient the messages being sent out by the brain to inform the body to perform a task arrive damaged or don’t arrive at all.

This disruption in information flow is caused by a body’s immune system having an abnormal response against the central nervous which creates inflammation that ultimately damages the nerve fibers, cells, and nerves themselves.  The name “multiple sclerosis” is derived from the multiple layers and incidents of scar tissue that form as a result of the damage to the central nervous system; multiple scars = multiple sclerosis.

The cause of MS is still unknown.  However, Scientists believe it can be attributed to a combination of genetics, abnormalities in the immune system and environment factors that contribute to the formation of the disease. MS affects nearly 1 million people in the United States and 2.3 million people globally.  Although you can develop MS at any age, it is most commonly diagnosed between the ages of 20 and 50.


MS Symptoms and Early Warning Signs

MS symptoms begin to show due to the damage to the central nervous system as a result of the inflammation cause by the immune systems abnormal response in the body.  Symptoms of multiple sclerosis are unpredictable and vary greatly across individuals which can make it difficult to diagnosis initially.  These symptoms can be temporary or permanent and it is very common for symptoms to change in type and intensity over time.

Early MS warning signs include:

  • Tingling and numbness
  • Vision problems
  • Weakness and fatigue
  • Bladder issues
  • Pains and spasms
  • Sexual dysfunction
  • Cognitive issues

If you begin to experience signs and symptoms of MS, it is advised you see a medical professional immediately as research has shown that the damage caused from MS can be most severe in the first-year vs later years.  Your doctor can recommend a treatment and management plan to decrease frequency of relapse and slow the progression of the disease while addressing your unique MS needs.


MS Quick Facts

  • Nearly 1 million people in the united states suffers from MS
  • Women are 2 to 3 times more likely to develop the disease than men
  • MS is far more prevalent in northern and colder climates
  • MS affects nearly all ethnicities, though it is most common in Caucasians, specifically of Northern European ancestry

15% of people with MS have at least one family member who also has the disease


Types of MS

There are four types of MS relating to the different ways the disease impacts the body over time.

Relapsing-Remitting Ms (RRMS)

Type 1 Diabetes is characterized by the pancreas’ inability to produce any insulin due to damaged beta cells, the cells that produce insulin. The beta cells are damaged because type 1 diabetes is an autoimmune disease, meaning the immune system mistakenly attacks these cells. People under the age of 20 are usually the ones to have Type 1 Diabetes. These people must take insulin injections to manage this disease.

Secondary-Progressive Ms (SPMS)

In SPMS, symptoms worsen steadily over time, and can include periods of relapses and remissions. Most people who are diagnosed with relapse-remitting MS (RRMS) will transition to SPMS at some point.

Primary-Progressive Ms (PPMS)

This form or MS is more rare, occurring in only about 10% of MS patients. PPMS is a slow progression of worsening symptoms from the beginning, with no relapses or remissions.

Progressive-Relapsing Ms (PRMS)

PRMS is the rarest form of MS impacting just 5% of people with MS. PRMS is characterized by a steadily worsening disease state from the beginning, with severe relapses but no remissions.

Multiple Sclerosis (MS) Treatments

Although there is no cure yet available for MS, many treatment options are available that can significantly decrease the number, frequency, and intensity of relapses as well as slow the progression of the disease.

It is important to consider a comprehensive care-plan with your healthcare team that includes medications, rehabilitation strategies, and complementary and alternative medicines to ensure an effective treatment plan that addresses your overall wellness and quality of life.

There are several medicine treatments available to treat symptoms of MS, many of which have been vetted through clinical trials and are now FDA approved.  Treatments are administered by injection, IV, or orally and can be tailored to your unique needs.

  • Beta Interferons – For treatment of relapse-remitting MS. This medication is administered via injection with a frequency of once per week to every other day.
  • Fingolimod – This treatment is taken orally and is used in all forms of relapsing MS to reduce the frequency of relapses and delay the physical impacts of the disease
  • Glatiramer acetate – This is a daily injection used in the treatment of relapse-remitting MS
  • Teriflunomide – Administered orally on a daily basis, this treatment is appropriate for all forms of relapsing MS

Through breakthroughs in treatment, comprehensive care, and lifestyle changes the life expectancy of individuals with MS has increased over time with an overall life expectancy of about 7 years less than the general population.  Many of the complications that can lead to premature death amongst people with MS can be prevented or managed through proper treatment and lifestyle adjustments.

Match to Multiple Sclerosis Clinical Trials

Interview with an Expert

Dr. Lijo John

Dr. Lijo John is a community pharmacist with 9 years of experience and graduated from Rutgers University in 2012. He has extensive experience serving patients with a focus in geriatric medicine, diabetes management, and preventative medicine such as immunizations and lifestyle modification counselling. Dr. John also enjoys writing and presenting on complex medical topics aimed at the general population to drive positive behavioral change in topics such as vaccine hesitancy and smoking cessation.

An Overview of Multiple Sclerosis

Multiple Sclerosis (MS) is an inflammatory disease of the central nervous system and has a genetic as well as environmental component. The underlying causes of MS are still unknown, and there is no cure for the disease available. MS is classified into four subtypes of the disease: relapsing remitting MS (RRMS), secondary progressive MS (SPMS), primary progressive MS (PPMS), progressive relapsing MS(PRMS)1.

How Has Treatment Developed Over Time?

Prior to selecting pharmacological therapy, a patient should consider modifiable risk factors such as smoking, excess body weight and Vitamin D deficiency. During exacerbations that cause functional decline, intravenous high dose corticosteroids such as methylprednisolone are used to reduce severity and recovery time. Initial therapy usually involves one of four Interferon formulations, or glatiramer acetate (Copaxone). Interferons were the first class of therapy shown to improve the natural progression of the disease. Glatiramer acetate has been shown to be comparable to IFN’s in reducing annual relapse rates and may also slow the progression in RRMS1.

What is the Current Standard of Care?

Beyond the immunomodulatory therapies such as IFNs and glatiramer, there are also immunosuppressive options available for more progressive forms of the disease. Monoclonal antibodies such as natalizumab, alemtuzumab, daclizumab, and ocrelizumab are administered either intravenously or through a self injection. Oral agents such fingolimod, teriflunamide, and dimethyl fumarate are available for patients who do not wish to or are not eligible for monoclonal antibody treatment2.

What Are Some Newer Treatments?

The effectiveness of pharmacologic treatment is uncertain and each patient’s treatment course should be individualized once in the progressive stage. These agents all come with various risks and these factors should be weighed by the patient with their clinician. Recent advances in combatting MS include novel delivery systems such as nanoparticles that may deliver the medication more effectively to brain lesions3. Researchers have also found a possible benefit in utilizing autologous hematopoietic stem cell transplants (aHSCT) to treat MS, as a small cohort of patients have shown no progression of their disease after 10 years4. Investigators are also exploring the possibility of using progenitor cells to repair the demyelination that occurs in MS patients, but this course of inquiry is still in its early days5.

Multiple Sclerosis (MS) Clinical Trials

MS Clinical trials have been imperative to the approval of the currently available MS treatments that are now FDA approved.  As researchers continue to seek a cure and treatment for this disease, continued participation in new and ongoing MS clinical trials is essential.

Benefits of Clinical Trial Participation:

  • Clinical trial participants benefit from a closer monitoring of their disease
  • Participants are given access to cutting-edge MS research studies and treatments
  • Access to new treatments
  • Participants play an active role in the management of their disease
  • Most participants report positive experience throughout the duration of the trial

There is significant MS research occurring across the country leading to many breakthroughs in treatments and deeper understanding of the multiple sclerosis.  If you are interested in participating in MS clinical trials, there are many ways to get involved.  Below you can find a list of new and ongoing clinical trials that are currently seeking participants to join:

Match to Multiple Sclerosis Clinical Trials

Glossary

Autoimmune condition or disorder: A process in which the body’s own immune system causes illness by mistakenly attacking healthy cells, organs, or tissue in the body.

Central nervous system (CNS): The part of the nervous system that includes the brain, optic nerves, and spinal cord. The nerves that leave the spinal cord and go to the rest of the body make up the ‘peripheral nervous system’.

Immune-Mediated Disease: characterized by common inflammatory pathways leading to inflammation, and which may result from, or be triggered by, a dysregulation of the normal immune response.  MS is an immune-mediated disease.

Myelin: the protective coating around nerve fibers in the central nervous system – is a primary target of the immune attack in MS.

References

  • DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey L. eds. Pharmacotherapy: A Pathophysiologic Approach, 10e. McGraw-Hill. https://accesspharmacy.mhmedical.com/content.aspx?bookid=1861&sectionid=146028752
  • Bennett, Jeffrey & Miravalle, Augusto. (2010). Recent advances in the treatment of multiple sclerosis. Journal of Experimental Pharmacology. 2. 2-155. 10.2147/JEP.S7822.
  • Yujun Zeng, Zhiqian Li, Hongyan Zhu, Zhongwei Gu, Hu Zhang, and Kui Luo. Recent Advances in Nanomedicines for Multiple Sclerosis Therapy. ACS Applied Bio Materials 2020 3 (10), 6571-6597. DOI: 10.1021/acsabm.0c00953
  • Boffa G, Massacesi L, Inglese M, et al. Long-Term Clinical Outcomes of Hematopoietic Stem Cell Transplantation in Multiple Sclerosis [published online ahead of print, 2021 Jan 20]. Neurology. 2021;10.1212/WNL.0000000000011461. doi:10.1212/WNL.0000000000011461
  • Orthmann-Murphy J, Call CL, Molina-Castro GC, et al. Remyelination alters the pattern of myelin in the cerebral cortex. Elife. 2020;9:e56621. Published 2020 May 27. doi:10.7554/eLife.56621