Np001

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Lkaibel

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Hi-

My husband has been asked to come in and be tested to see if he has elevated C Protein levels (which indicate inflammation). If he does, they want him to be part of a study of NP001 (which may be more effective on people who have elevated levels). It is your typical 1/2 of people get a placebo, etc. study.

I was wondering if others have experience with NP001. It has apparently been researched since at least 2011 (I hate the pace of this stuff!).

I think at this point Brian is eager to join a study because we only go downhill from here anyway, and if there is even a slim chance that an study drug would slow that up, that's a bonus.
 

lgelb

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It has been around for a long time. The last study was fairly convincing that the elevated CRP people at a higher dose have a shot at benefit.
 

Lkaibel

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I feel better knowing it has been around for a long while. Next I guess we see if he has an elevated level.
 

avnl

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M alas did not have an elevated protein.��
Anna
 

diagnosed2016

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We are going to be in the study, I think. Husband has the biomarker they are looking for, but he's been taking a med they don't want so he has to wait a few weeks to restart the process. It's the one study we've been hoping to get into. Hoping to start next month.
 

affected

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Hope you know soon Lenore.

Thank you so much to every PALS who takes part in any study!
 

robynp

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I as well have been identified as a good candidate. I am awaiting my appointment date for the medical screening.:smile:
 

Lkaibel

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I think maybe even if we are not good for this study (have to have the right markers, etc, so we will see) it would make Brian feel better to just try something. Maybe we will do Lunasin if he is not a good study candidate. I know you can do the protocol for that OTC.
 

konagirl

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Hi Diagnosed2016, do you mind me asking which drug your husband is having to come off of? We go in for pre-screening in two weeks and if there anything my hubby needs to stop taking, I would rather him do it now as opposed to getting to the pre-screening and finding out.
 

AKNate

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I just posted a Webinar in the Research thread - you guys should have a listen to it. They mention that the NP001 is the trial to be in right now and is the most encouraging.
 

Lkaibel

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Looks like we will know in early March if we are eligible. The nurse said the majority of ALS patients have an elevated blood level so in all likelihood will be eligible. They do the blood test 2/28 and will have results 3/3.
The University of Minnesota has been accepted as a study participant for sure. Mayo sometime elbows them out I guess so that part was in question.
 

diagnosed2016

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Konagirl, he's on Mexiletine as an off label prescription. It's being used in a study right now so they count it as "experimental" even though it's not. So If he's on it, stop taking it and don't mention it to them (wean off though). It doesn't show up in bloodwork it's just whether or not they have it on their file. Drug trials are such a joke. By the time they process everything you don't qualify anymore. So disheartened. They had been in contact with us since before the study started and then we "fell through the cracks" and they forgot to review his medical records to admit him to the study. So we could have started months ago... months where we might have had no decline... also they aren't doing an open label portion or allowing any compassionate use at the end because if they get good results they want to push for phase 3 quickly.
 

Lkaibel

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Diagnosed, I guess we see it like this with the drug trials: They are not actually FOR the people dealing with ALS now, that's the truth and I think that the researchers are afraid to speak that truth because they feel all participation would go "poof".

For one thing, there is a 50/50 chance that you will get a Placebo. I think in ALS the odds that drug you do get will actually help are slimmer than that by far, IF you get the drug. Next up, the majority of trials do not allow compassionate use after the study to my knowledge. This to me is a rather inexplicable and sucky part of the whole thing. I am going to make very sure that Brian understands that part, because I know personally it would kill me to stop using a drug that was helping, but I am not going to make any choices for him.

I feel like it would be good to join a trial and get at least a time of some benefit, but that is so not THE reason to me to join a trial. The reason is to help research. However, I do wonder if these research arrangements are actually compassionate in any real way, and even if research methods need to be done this way, or if money is being well spent. Risks are also not to be minimized, and the ONLY reason I feel comfortable with this study is the drug has actually been in circulation for several years without major adverse affects. Steve Gleason participated in some research that set him back and sped up his progression, for just one famous example.
 

Nikki J

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I think the consents usually have wording that says pretty much what Lenore says about may not benefit you but may benefit others in the future. I think an extension with open label is most commonly after a phase 3 when it does happen both because they would want to put their resources toward moving a promising drug into phase 3 quickly and because unfortunately good phase 2 results do not always pan out.

Most of you do not remember the dex trial in 2012. Very promising we thought. Expectations were they would give drug access to all trial participants after the phase 3 and push for quick approval. It failed phase 3 even though phase 2 looked good. Devastating

I have heard Dr Bedlack say there is evidence that PALS who participate in trials do better. He said since nothing has been effective yet there may be benefit in the process and the relationship you form with the trial staff and by extension the clinic.
 
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