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AmpligenCNS

Current Research

The Hunter-Hopkins Center is actively involved in CFS, ME and FM research in the United States and worldwide. This insures that our patients will receive accurate, up-to-date information and treatments.

 

Project #1: Ampligen. We have received approval from the Federal Drug Administration to administer Ampligen to seriously ill patients with CFS. For more information, click the Ampligen link at the left.

Project #2: Ampligen. We also received approval from the Federal Drug Administration to participate in an FDA Phase III double-blind crossover study of Ampligen sponsored by the manufacturer, Hemispherx Biopharma (completed July 2004).

Project #3: RESST Study (eszopiclone/LunestaTM). We have completed a study for Sepracor to study their new sleep medication, Lunesta, in patients with CFS/FM ( April 2005).

Project #4: Hunter-Hopkins has completed two studies for Pfizer Pharmaceuticals to study pregabalin/LyricaTM  for the treatment of fibromyalgia pain.  Pregabalin is a GABA potentiator that is also useful for seizures and anxiety. Some results of this study were published in the April 2005 issue of Arthritis and Rheumatism. The abstract is available from ProHealth, or ImmuneSupport.com.

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Project #5: We have completed a study of almotriptan/AxertTM (Ortho-McNeill) for the treatment of migraine. This was a post-marketing study to determine the effectiveness of Axert for delayed treatment of migraine, which is common in CFS/ME.

Project #6:Neurally Mediated Hypotension and Symptomatic Orthostatic Tachycardia Syndrome (or SOTS). An ongoing study of orthostatic intolerance and autonomic dysfunction in CFS/ME/FM.  Our clinic introduced the concept of SOTS at the 1996 AACFS Conference in San Francisco, and we continue to study features of orthostatic intolerance in CFS/ME/FM.

Project #7: LEAP Study. We have completed a Phase IV study of the Lilly product, duloxetine/CymbaltaTM.  Duloxetine is a Norepinephrine Serotonin Reuptake Inhibitor (NSRI) that is expected to improve mood and reduce fibropain.

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Project #8: In July 2004 we completed a pilot study of CNS Vital Signs(TM), a computer-based psychometric test. We believe that this test will improve the availability and reduce the cost of traditional neuropsychometric testing. CNS VS could be used to establish disability as well as follow cognitive ability over time. To view the results of this study, click here.

Project #9: Hunter-Hopkins completed a pilot study using the Accusplit 120TM stepometer to monitor activity in persons with CFS/ME/FM.  This pedometer-like device measures one's activity over several days, allowing us to subtype individuals (high, low, or normoactive) and follow progress over time. We found that there is a great deal of variability between pedometers (even from the same manufacturer), but a stable normoactive PWC typically takes 6000-7000 steps per day, whereas healthy controls took about 10,000 steps per day. We therefore recommend the use of a simple pedometer to monitor activity.   Aim for about 6000 steps daily.

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Project #10: Physical findings in CFS/ME. An ongoing study to identify significant physical findings in CFS/ME.  We anticipate a multi-center, cross-specialty application of our findings in order to determine the incidence, sensitivity, and specificity of each finding.

Project #11: CFS and pregnancy. A retrospective chart review of our experience. Completed and published in the CFS Research Review. Click review.

Project #12: Transfer factor. We completed a pilot study of this immunomodulatory product, in cooperation with Pro Health, Inc., and Immunosciences Laboratory (December 2002)

Project #13: Stimulant therapy in CFS. A prospective study using modafinil (ProvigilTM, Cephalon Inc) in persons with CFS (completed December 2001).

Project #14: Symptoms Predict the Outcome of Tilt Table Testing in CFS/ME/FM . We retrospectively studied 104 persons with CFS/ME or FM in our Cardiovascular Laboratory to determine what symptoms might predict a positive tilt table test. We found that inability to stand in place, fainting, and flushing were most likely to predict a positive TTT (sensitivity of 71% and a negative predictive value of 75%). For a summary of the study, click here.

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Project #15:  We studied a Norepinephrine Serotonin Reuptake Inhibitor (NSRI) called reboxetine for Pfizer pharmaceuticals. This drug has shown promise for the treatment of CFS/ME and FM. Enrollment is now closed for the original study, but continuing studies are planned.

Project #16:  We have completed the study of an antiepileptic drug called lacosamide for the control of pain in persons with FM (PWFs). This study was sponsored by Schwarz Pharmaceuticals.

 

In May 2008 we anticipate starting new drug studies for Boeringer-Ingleheim and Pfizer.   Interested persons who live locally should contact Wendy Fallick, at (704) 543 9692.

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Hunter-Hopkins Center maintains a multi-specialty consultation and research site in Charlotte, North Carolina, and conducts clinical trials, nutraceutical trials, and clinical research. These studies are performed independently or collaboratively with other researchers throughout the world.

For more information, contact Wendy Fallick, our research coordinator, at the Hunter-Hopkins Center.



Updated February 2008

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