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Ampligen and new drug? North Carolina

Discussion in 'Active Clinical Studies' started by SickOfSickness, Aug 25, 2010.

  1. SickOfSickness

    SickOfSickness Senior Member

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    I came across this, and I thought I would post it in case that helps anyone. Sorry if it is a duplicate or anything. If I read it right, they want the sicker patients, with Karnofsky of 60 or lower.

    http://clinicaltrials.gov/ct2/show/NCT00215813
     
  2. Sasha

    Sasha Fine, thank you

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    Drs Petersen, Bateman and Lapp are listed as the principal investigators! What a team!
     
  3. Sasha

    Sasha Fine, thank you

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    Interesting - it doesn't have a control condition. All patients get Ampligen.
     
  4. OverTheHills

    OverTheHills

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    Confused - is this the study thats already going? if so why has the record been processed just now?

    Study Start Date: March 1997
    ClinicalTrials.gov processed this record on August 24, 2010


    Duh?????? Muddleheaded

    Oth
     
  5. Daffodil

    Daffodil Senior Member

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    i think this is just an ongoing trial that has been going for several years. maybe they mean they last updated the site on aug 24th?
     
  6. Sunshine

    Sunshine Senior Member

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    Wasn't it reported Cindy Bateman was pulling out of the drug trial?
     
  7. Hope123

    Hope123 Senior Member

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    This is old I believe. Some data were likely presented to FDA from this last Fall when Hemispherix was trying to get Ampligen approved but failed due to, as I understand, incomplete data. Peterson et al. might be pushing another trial but that would be aside from this one. Hemispherix has long history of not fully allowing researchers/ clinicians/ the public access to the data.
     
  8. LaurelW

    LaurelW Senior Member

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    Dr. Bateman stopped doing the trial a year ago.
     
  9. shannah

    shannah Senior Member

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    Well here's a clinical trial Dr. Lapp is currently doing now. Wonder if there's any connection.

    Possible New Chronic Fatigue Syndrome Drug Investigated


    Possible New Chronic Fatigue Syndrome Drug Investigated
    Wednesday August 25, 2010

    http://chronicfatigue.about.com/b/20...e-syndrome.htm


    A drug called droxidopa is now moving into phase II clinical trials as a treatment for chronic fatigue syndrome.

    Droxidopa is a synthetic version of a substance your body uses to make the neurotransmitter/hormone norepinephrine. Norepinephrine performs several important functions, and you body also uses it to produce dopamine, another important neurotransmitter. Studies have shown that this drug can improve fatigue, weakness, concentration, and orthostatic hypotension (blood pressure drop upon standing, which causes dizziness) in several conditions, including Parkinson's disease. These symptoms are also common in chronic fatigue syndrome, and studies show that some people with this condition may have low levels of norepinephrine and dopamine.

    The study will take place at the Hunter-Hopkins Center in Charlotte, North Carolina, under the supervision of Dr. Charles Lapp. Lapp has been involved in both the American Association for CFS and the American Fibromyalgia Syndrome Association.

    Droxidopa also is being studied as a possible fibromyalgia treatment. It is not yet approved for any use in the U.S. However, its manufacturer, Chelsea Therapeutics, is working toward approval for neurogenic orthostatic hypotension.
     
  10. Sunshine

    Sunshine Senior Member

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    [/QUOTE]

    Droxidopa is an orally active synthetic precursor of norepinephrine currently approved and marketed in Japan for the treatment of orthostatic hypotension. By replenishing depleted norepinephrine via endogenous enzymatic pathway, Droxidopa allows for re-uptake of norepinephrine into peripheral nervous system neurons stimulating receptors for vasoconstrinction and providing physiological improvement in symptomatic neurogenic orthostatic hypotension patients.

    With over 15 years of proven safety and efficacy in its target indications, Droxidopa provides a unique opportunity to accelerate Chelsea's drug development activities, expand its product pipeline and help finance the establishment of a sales and marketing infrastructure prior to commercialization of the companys other compounds including CH-1504.

    Originally approved in 1989 for the treatment of frozen gait or dizziness associated with Parkinson's Disease and for the treatment of orthostatic hypotension, syncope or dizziness associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy, DSP expanded marketing approval in 2000 to include treatment of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.


    [/QUOTE]
     
  11. SickOfSickness

    SickOfSickness Senior Member

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    Now that processed date has changed to the 25th, maybe it updates every day and is useless.

    I thought maybe they had people drop out and opened it back up to get more.
     

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