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droxidopa trial with Dr. Lapp

Discussion in 'Active Clinical Studies' started by Rrrr, Aug 19, 2010.

  1. Rrrr

    Rrrr Senior Member

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    http://www.marketwatch.com/story/ch...igue-syndrome-2010-08-19?reflink=MW_news_stmp

    press release

    Aug. 19, 2010, 7:30 a.m. EDT Recommend Post:
    Chelsea Therapeutics Announces Initiation of Investigator-Led Phase II Study of Droxidopa in Chronic Fatigue Syndrome

    CHARLOTTE, N.C., Aug 19, 2010 (GlobeNewswire via COMTEX) -- Chelsea Therapeutics International, Ltd. /quotes/comstock/15*!chtp/quotes/nls/chtp (CHTP 3.59, +0.04, +1.13%) announced that a new investigator-led phase II clinical study of Droxidopa, an oral synthetic precursor of norepinephrine, has been initiated in chronic fatigue syndrome (CFS).

    CFS is a complex and crippling disorder characterized by extreme fatigue that is not improved by rest. In addition to fatigue, patients with CFS experience symptoms, similar to that of fibromyalgia including, weakness, muscle pain, impaired memory and concentration. Droxidopa has been shown to improve symptoms of fatigue, weakness and concentration in neurogenic orthostatic hypotension associated with a variety of conditions including Parkinson's disease, multiple system atrophy and pure autonomic failure. Droxidopa is also being studied in an ongoing Phase II trial in fibromyalgia where, during an interim analysis, an independent data monitoring committee saw meaningful efficacy in multiple treatment arms.

    Dr. Charles Lapp, a former board member of the American Association for CFS and medical advisor to the American Fibromyalgia Syndrome Association, is conducting this single-center Phase II study at the Hunter-Hopkins Center in Charlotte, North Carolina. The trial will evaluate up to 600 mg TID of droxidopa and assess the clinical efficacy using changes in Patient Global Impression of Improvement (PGI-I). In this open-label trial, approximately 20 patients will be titrated to optimal therapeutic benefit over a two-week period after which they will continue treatment for 12 weeks. The primary outcome measure will be changes in PGI-I scores from baseline to the end of the 12-week treatment period. Secondary measures include changes in the Multidimensional Fatigue Inventory (MFI), Clinical Global Impression of Severity (CGI-S), Hospital Anxiety and Depression Scale (HADS), blood pressure before and after a tilt table test.

    "As we continue to work towards an approval for droxidopa for the treatment of neurogenic orthostatic hypotension, we are eager to expand the body of clinical research supporting potential indications that could be effectively treated with norepinephrine replacement therapy," said Dr. Simon Pedder, president and CEO of Chelsea. "We welcome the opportunity to support Dr. Lapp's efforts to characterize the therapeutic role of norepinephrine in chronic fatigue syndrome and believe that a favorable outcome from this study, combined with data being generated by our ongoing Phase II trials in fibromyalgia and adult attention deficit hyperactivity disorder, will further highlight the integral role of norepinephrine as a neurotransmitter central to the etiology of a host of disorders."

    About Droxidopa

    Droxidopa, the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure -- a group of diseases that includes Parkinson's disease, multiple systems atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia and adult attention deficit disorder in two ongoing phase II trials and completed a phase II in intradialytic hypotension (IDH) study with positive results.

    About Chelsea Therapeutics

    Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, Northera(TM) (droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Northera, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).

    This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates droxidopa and CH-4051, reliance on collaborations and licenses, intellectual property risks, our need to raise additional operating capital in the future, our history of losses, competition, market acceptance for our products if any are approved for marketing, and reliance on key personnel including specifically Dr. Pedder.

    This news release was distributed by GlobeNewswire, www.globenewswire.com

    SOURCE: Chelsea Therapeutics

    CONTACT: Chelsea Therapeutics:
    Investor/Media Relations
    Kathryn McNeil
    704-973-4231
  2. Rrrr

    Rrrr Senior Member

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    has anyone heard of this med or tried it?? this is the first i have heard of it.
  3. dsdmom

    dsdmom Senior Member

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    Yes, I have heard of it. My neurologist @ UMASS has been involved w/ their trial for orthostatic hypotension. He wanted me to be part of it but I don't meet the criteria for OH - my bp is just low all the time - it doesn't drop on standing to meet OH criteria. He seems to think this will be a good drug choice for me though once it is approved. I'm happy to see that they are looking @ it in CFS - which means not just for dropping bp on standing.

    I actually am very much looking forward to having this drug approved. It's been in use in Japan for a long time and is considered very safe. Of course I always have problems with drugs so we'll see...but I haven't been able to tolerate florinef or midodrine. Which, as a side note, may be withdrawn from the market relatively soon. At least the brand name - the jury is still out on generics.

    Anyway, I see the above as a very good thing!
  4. sensing progress

    sensing progress Senior Member

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    Tucson, AZ
    Which may be withdrawn from the market? Florinef or midodrine?
  5. Rrrr

    Rrrr Senior Member

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    midodrine may be withdrawn.
  6. Navid

    Navid Senior Member

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    did anyone try this drug yet? if so, can you share your results...hopefully good : )

    thanks
  7. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    Interesting!

    The only drugs that really helped me with OI (and they helped a lot) were norepinephrine re-uptake inhibitors. They also normalized my temperature. I've heard of trials of this one. Hope it goes through and hope it won't be wildly expensive! (that is unlikely!). I tapered off the others because of expense and getting better.

    Midodrine was horrible for me too.

    Sushi
  8. August59

    August59 Daughters High School Graduation

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    Upstate SC, USA
    Sushi - Have you tried Savella? Have you tried Cymbalta? If so, was it very expensive?
  9. Sushi

    Sushi Moderator and Senior Member Albuquerque

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    Hi August,

    I did try cymbalta--low dose (I think it was 20 mg.) along with strattera. They helped with OI a lot--particularly stattera which is a norepinephrine reuptake inhibitor. But they were very hard to titrate up to even the low dose--it took about 6 weeks of opening the capsules and very slowly titrating the dose up.

    I stopped them because 1) a no longer needed them, and 2) they are extremely expensive. I haven't tried Savella but I know it has a quite different formula from Cymbalta. I didn't try it because I don't have nearly as much need of OI support now, and I prefer to take the minimum of drugs. Both these medications had to be tapered off very slowly as well--taking several months.

    Hope that helps,
    Sushi
  10. sensing progress

    sensing progress Senior Member

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    I have never heard norepinephrine being related to OI. Can you elaborate on this Sushi? Any idea why these NRIs helped you?

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