The Effects of Fampridine-SR on Walking in People with MS

Acorda Therapeutics, Inc., recently announced positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple sclerosis (MS). Statistical significance was achieved on all three efficacy criteria defined in the Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA). A significantly greater proportion of people taking Fampridine-SR had a consistent improvement in walking speed, the study’s primary outcome, compared to people taking placebo (34.8% vs. 8.3%) as measured by the Timed 25-Foot Walk. In addition, the effect was maintained in this study throughout the 14-week treatment period and there was a statistically significant improvement in the 12-Item MS Walking Scale for walking responders vs. non-responders.

The average increase in walking speed over the treatment period compared to baseline was 25.2 percent for the drug group vs. 4.7 percent for the placebo group. Increased response rate on the Timed 25-Foot Walk was seen across all four major types of MS. In addition, statistically significant increases in leg strength were seen in both the Fampridine-SR Timed Walk responders and the Fampridine-SR Timed Walk non-responders compared to placebo. The Company intends to present comprehensive data at an upcoming medical meeting.

“We are delighted with the results from this trial, which are consistent with Acorda’s prior Phase 2 study in people with MS. We will request a meeting with the FDA as soon as possible to discuss next steps for the Fampridine-SR program,” said Ron Cohen, MD, President and CEO. “Acorda is committed to the development of therapies that will improve the function and lives of people with MS, and we wish to thank the physicians and people with MS who participated in this trial.”

“Many people with MS experience nerve damage that eventually impairs walking. Currently, no therapies are indicated to improve neurological function, such as loss of mobility, in MS,” said Andrew Goodman, MD, director of the Multiple Sclerosis Center at the University of Rochester. “Based on the results of this trial, Fampridine-SR could represent a new way to treat people with MS. In this study, a significantly higher proportion of subjects experienced a consistent improvement in walking speed with Fampridine-SR than with placebo, and this was accompanied by a reduction in the degree of disability that the subjects reported in their daily activities related to mobility.”

For more information, please visit www.acorda.com/.

Study Warns of Heat Balance Disturbance When Exercising with SCI

A new study conducted by researchers from the Department of Physiology at the University Medical Center Nijmegen, The Netherlands, reports that individuals with spinal cord injuries (SCIs) are at greater risk for a disturbed heat balance during exercise in the cold and in the heat than other individuals. Researchers recommend that people with SCI take intensive precautions before exercising in the cold or heat.

“In summary, mean body temperature and body heat content in the cold decreased in SCI, despite exercising. In the heat, mean body temperature and body heat content seems to increase more in [individuals with] SCI than in [other individuals].”

This study was reported in the International Journal of Sports Medicine.

For more information, please visit www.thieme-connect.com/ejournals/toc/sportsmed.

A Randomized Crossover Study of Bee Sting Therapy for MS

Bee sting therapy is growing increasingly popular as treatment for patients with MS in the confidence that it can stabilize or even ameliorate the disease. There have been no clinical studies, however, to justify its use scientifically. In a randomized, crossover study, a group of researchers from the University Medical Center Groningen in the Netherlands assigned 26 patients with relapsing-remitting or relapsing secondary progressive MS to 24 weeks of either medically supervised bee sting therapy or no treatment. Live bees (up to a maximum of 20) were used to administer bee venom three times per week. The results of this study were published in the December 2005 issue of Neurology.

The principle concern was the cumulative number of new gadolinium-enhancing lesions on T1-weighted MRI of the brain. Secondary areas of interest were lesion load on T2*-weighted MRI, relapse rate, disability, fatigue, and health-related quality-of-life.

The authors report that during bee sting therapy, there was no significant reduction in the cumulative number of new gadolinium-enhancing lesions, the T2*-weighted lesion load further progressed, and there was no significant reduction in relapse rate. Furthermore, no improvement of disability, fatigue, or quality of life was observed. However, bee sting therapy was well tolerated and no serious adverse side effects occurred. It was concluded in this trial that treatment with bee venom in patients with relapsing multiple sclerosis did not reduce disease activity, disability, or fatigue and showed no improvement in quality of life. This article was published in Multiple Sclerosis Quarterly Report, Volume 25, Issue 4. (Available from: www.pubmed.gov, PMID: 16221950)

Neural Prosthetics Trial Participants Needed

The Anderson Lab at Caltech, in Pasadena, California, is currently researching neural prosthetics to restore function to individuals with spinal cord injuries and disorders. In the first iteration of the planned device, the scientists hope to restore communication capabilities, by thought or intent alone, planned to include dialing a phone, typing, sending and receiving e-mails, controlling radio/TV and lighting, surfing the web, playing games, and notifying caregivers of emergencies. In the second phase they hope to restore mobility to paralyzed and/or artificial limbs.

As they move toward the actual trial––approximately 16 to 18 months from now––Caltech researchers want to ensure that the capabilities on which they are focused are indeed the capabilities that the people they hope to help would find most important. They would like to hold focus groups or personal interviews with tetraplegic individuals who are able to speak and are not cognitively impaired. If you’re interested in participating in these discussions and live in the greater Los Angeles area (Ventura County, L.A. County, Riverside County, San Bernardino County or Orange County), please contact Kimberly Seidman at 818-400-2247, or email kakseidman@yahoo.com.