Clinical research study in St. Louis for an investigational drug for multiple sclerosis.

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Today, we completed a 10K (6.2 mile) military-style obstacle course to raise money for the Gateway Chapter of the National MS Society.  Thanks to all our supporters who propelled us to the top fundraising team :)    We climbed walls, swung on ropes across mud pits, and crawled through mud-filled tunnels.   And then the giant mud slide!

The MS Center for Innovations in Care was the only center in St. Louis to participate in the relapsing remitting trials TRANSFORMS and FREEDOMS 2 for FTY720.

Ampyra is FDA-approved to help walking in people with MS.   Improvement was seen in 35-43% of patients in trials.  Four out of 229 patients did have seizures during the extension phase of one trial after the main part of the trial ended.  A big concern is driving restrictions which vary state by state if you have a seizure.

Failed treatments recently studied in MS:   Aricept (Donepezil) for thinking and memory,  Lipitor for first attack of MS, and Omega 3 Fatty Acids (Fish Oil) for depression in MS.

CCSVI Update:   Dr. Zamboni reported at the American Academy of Neurology Meeting in Toronto that 90% of MS patients and none of 45 non-MS patients had vein blockages.  Interestingly,  these percentages were very different from Dr. Zivadinov’s announcement of 56% of MS patients and 22% of healthy control patients had vein blockages.  An independent, multi-center study is necessary to confirm whether vein blockage is indeed more common in MS.  A study of 16 MS patients (all happen to have CCSVI) showed increased iron deposits in parts of the deep brain (thalamus and hippocampus) on MRI.  However, these parts of the brain are not typically involved in MS.  Iron can be found in clean-up cells called microglia and in cells that make myelin called oligo’s.  Therefore, iron from red blood cells into the brain from vein occlusion seems hard to prove based on this observation alone.  Reduced blood flow in the brain and decreased cerebrospinal fluid flow rate were also reported in CCSVI, but no connection was made between the actual veins that were occluded to the side of the brain with decreased blood flow.

Further verification of the test will be required.  If you do not have antibodies to the virus, your PML risk should be extremely low if the preliminary result hold true.  There have been 31 cases of PML reported in over 48,000 currently treated patients.

Biogen Idec Inc. at JPMorgan Healthcare Conference Tuesday, January 12, 2010 http://investor.biogenidec.com

The U.S. Food and Drug Administration approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis.  In clinical trials, patients treated with Ampyra ( pronounced am-PEER-ah) had faster walking speeds than those treated with an inactive pill (placebo).

Ampyra is a compound that blocks potassium channels which allows nerves to transmit impulses better.  Two phase III trials of Amprya 10 mg twice a day showed benefits in some people with MS on their ability to walk 25 feet. 

In the first study, 72 patients were treated with placebo and 228 patients were treated with Ampyra over 14 weeks.  Of the 35% of patients who responded to Ampyra, the average change in walking speed increased 25%.

In the second study, 119 patients were treated with placebo and 120 patients were treated with Ampyra over 8 weeks.  43% of treated patients responded.   Ampyra worked in all MS types including relapsing remitting, secondary progressive and primary progressive disease.

The side effects of Amprya include dizziness, trouble sleeping, headache and fatigue.  Although these two trials did not report any seizures, seizures have been reported in people on higher doses of the same active chemical also called 4-aminopyridine.  One seizure can legally prevent you from driving for 6 months in some states.  4-aminopyridine capsules can be made at some compounding pharmacies, but Ampyra will soon be widely available.

Goodman AD. AAN 5/1/07; ECTRIMS 9/20/08 P909.

Zamboni performed a trial of opening of the vein blockages with angioplasty in 65 MS patients.  Patients had less relapses and MRI activity after treatment, but there was no comparison group that got a fake “sham” procedure.  Previous trials of patients on no treatment (placebo group) show less relapses and MRI activity over time naturally so follow-up larger studies are needed to see if this treatment is really effective.   There also has been reports of a fatal brain bleed after stenting and a stent moving into the heart so trials will be necessary to see if stenting works if indeed people with MS have more frequent vein blockages.

Overall, an intriguing observation that needs to be verified at other centers.  Is the vein blockages causing MS or simply the result of MS inflammation on the veins?    Further research is needed!