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Results of the CLARITY Trial – Oral Medication for Multiple Sclerosis

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Have I ever mentioned that I hate shots? I don’t mean that I dislike them. I mean that I really, really have this thing about needles as it relates to being in the same vicinity as my body. I’ve always hated the pat little half-smile, as the nurse says, “Now, honey, you’re going to feel a little sting.” Yeah, right. Sting my @@)#$*&!!!

Despite my intense dislike of needles, I self-administer a shot every day. Why, you may ask? Because I have multiple sclerosis and all the major hitters in terms of MS treatments – Avonex, Beta Seron, Rebif and Copaxone – are all injection medications only. Other MS treatments involve intravenous infusions (again, a needle). There is currently no treatment available for MS in pill format. So, a girl does what a girl has to do. I’ve sucked it up and every evening for the past 9 and a half years I’ve had a “date” with the needle. Believe me, he’s not a date I like to keep and I can’t wait to send him packing!

For all of us needle phobia MS sufferers, injections may soon be a thing of the past. Hope just may be on the not-so-distant horizon. The results of the Cladribine Tablets Treating MS Orally (CLARITY) trial were released earlier this year. If approved by the FDA, Cladribine will be the FIRST oral medication approved for the treatment of MS. (Yeah! No more needles!)

The short and skinny on the trial results are as follows:

• Course of treatment: Participants were given either two or four courses of treatment each year during the trial. A course of treatment consisted of a single pill for a period of four to five days. That means that even with a four-course treatment during the year, you’re only looking at 20 pills a year.

• Relapse Prevention: Participants were 58 percent less likely to suffer a relapse. (Yes, I said 58 percent!)

• Progression of Disease: Participants MS disabilities were 30 percent less likely to worsen than those on placebo.

• Lead Researcher: Professor Gavin Giovannoni of Barts and The London School of Medicine and Dentistry, part of Queen Mary, University of London

• Manufacturer: Merck Serono (Geneva, Switzerland)

• Side Effects: Over the course of the trial, the most frequent reported side effects were headaches and nasopharyngitis (inflammation of nasal passages). Lymphophenia (reduction in number of white blood cells) was also a side effect of Cladribine.

Cladribine has not yet been approved for use to treat MS. Merck Serono will be applying for FDA approval for the use of Cladribine for MS sometime in mid-2009. The preliminary results look promising. However, as with any new drug, consult your doctor to determine if Cladribine is right for you.

©2009 Mary Kyle. For more articles by Mary Kyle, please visit www.texpen.com.

New Pill To Treat Multiple Sclerosis, Science Daily, 30 April 2009, http://www.sciencedaily.com/releases/2009/04/090429205613.htm

Low White Blood Cell Count, Mayo Clinic Staff, 26 Sept 2008, http://mayoclinic.com/health/low-white-blood-cell-count/MY00162

Cladribine Trial Results, Multiple Sclerosis, 26 Jan 2009, http://www.medicalnewstoday.com/articles/136647.php

Add a Comment2 Comments

Blogger

Yes, it really has been 10 years. Despite my whining about shots, I'm very grateful that I've had medication to take as it has enabled me to live such a healthy life! I don't regret that at all. BUT, I would be lying if I said that I was not looking forward to a day when science can offer me more. There are several new oral medications in the works right now. If any prove to be both safe and effective, then it will be a real breakthrough in treatment options. I'll be watching the approval progress and results with interest!

August 10, 2009 - 10:02am
EmpowHER Guest
Anonymous

Mary, has it really been nearly 10 years since you first told me the doctors had finally figured out what was wrong? I remember how ill you felt so often, and no one seemed to be able to say why. What a blessing this new oral medication will be! Why does every side effect seem to cause
headaches?! Love you, Susan D.

July 6, 2009 - 9:06am
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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