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Clinical Trial for Inhaled Levadopa


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#1 Mihai

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Posted 26 August 2013 - 09:25 PM

Hi everyone....

I am currently enrolled in a clinical trial for the new levodopa inhaler, which is a "rescue" med obviously delivered through the lungs. This is moving along in the trials and is currently being "trialed" in several locations in the U.S. as well as in several other countries. I can't say much about my experience, but it does hold great hope as a "rescue" dose of levodopa that can be inhaled (up to three times a day) to produce an "on" period when one goes "off" but needs to be "on." The effect should come within 5-10 minutes (as opposed to the 45 minutes to an hour or more that the oral medications take). This specific administration of levodopa would have vast application and use for each of us as you all well know! I am enrolled at the Cleveland Clinic in Ohio. I am the first of the five patients hoped for. If anyone is close to the Cleveland Clinic and is interested in getting involved, let me know. I can connect you with the study coordinator. This is my third clinical trial and has been a very positive experience (actually, all three have been great. There are good things in the works, so be encouraged! Get involved as you are able (especially while on the young end of the PD age spectrum!). You are needed and can help bring new treatments that have the potential to touch every PWP for the better. Happy journey to each of you!

Your friend,
Mihai

#2 noah

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Posted 28 August 2013 - 10:16 AM

please keep us posted on the study!

#3 Donald Ennis

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Posted 28 August 2013 - 11:50 AM

Yes please keep us posted, this is a cool idea

#4 Mihai

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Posted 29 August 2013 - 10:32 PM

Hello all,

This trial is going well. Here's an update from my appointment yesterday... I arrived in an "off" state. I was given a dose of the inhaled medication (or placebo...it's randomized, of course, so I don't "know" which I got!), and had the UPDRS (PD rating scale) administered 5 times: once before taking the med (or placebo) and then once at 10 minutes, 20 minutes, 30 minutes, and 60 minutes. My rating went from a 32 to a 27 in the first 10 minutes, and kept decreasing until I was at 20 by the 60-minute marker. Essentially, I didn't have to wait the usual hour or hour+ that it usually takes for the oral meds to kick in. This is exciting. If I have the med (as opposed to the placebo), it means that we may all eventually have access to a treatment option that allows us to get an "on" state in a matter of a few minutes. I would encourage anyone who is close to a trial site on this one to get involved. This med could potentially help every one of us in some way!

I'll keep you posted as the trial progresses!

Mihai

#5 noah

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Posted 01 September 2013 - 07:44 AM

I would be interested in how far this trial has progressed. Is it a phase 1 ,2 or 3? I would also be interested in what the next step it would take. Perhaps you could pick the investigator brain for us??thanks

#6 Mihai

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Posted 13 September 2013 - 09:04 AM

Hi noah,

Sorry I never responded to you on your question...it is in 2b trial status. The next step will be 3. I have had great success with this medication. They describe its use as "filling in the potholes" which it really seems to do...it bridges the gap between doses without taking forever to work! This will be a great help to many of us if it gets approved by the FDA for use. I'll be done with the trial by the end of September. They are still looking for several more participants at the Cleveland Clinic...

Mihai

#7 HazelBanks

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Posted 03 November 2013 - 05:55 AM

The practical way that levodopa has been absorbed is in pill form. But many patients who take the drug experience “off” periods – when the effects of the medication wear off before they are ready to take their next dose.  These “off” periods can be limiting, as they can leave patients in a state where symptoms such as rigidity or slowness of movement return. And I think you will get a good experience after this clinical trial so good luck.






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