dex triaL AND SOME QUESTIONS

[penney21]

Hi everyone,
i have a couple of questions?well maybe 3 questions. My brother is in the process of being diagnosed for als.neuros are 99% sure. He
has bulbar symptoms.they say it could pbp.what is the prognosis for pbp?
Has anyone heard anything else about the cancellation of the dex trial in the spring? This is a shame so people are counting on it. Sequoia you have done an excellent job with the petition.
Is 70 t0 90 good for the breathing test at the neuros office?

Cathy

 

[HelenL]

Cathy, sorry to hear about your brother's diagnnosis.

I was at the clinical trial yesterday and asked about the "Phase 3B" and it does seem to either be on hold or maybe not going to do it. Perhaps the data that they're looking for is being changed and they have to rewrite the protocols? Not sure, but it doesn't look like it will happen soon, thought that certainly could change.

 

[Q-man]

i'm in the dex trial. spoke with the coordinator yesterday and there was no mention of it being canceled.

70-90 per cent breathing test is good. my 1st one (last may) was 86. about 2 months ago it was 76.

 

[penney21]

Q-man
how are you doing on the dex. Trial?are you on the dex. Or the placebo? I heard th next phase 3 was being cancelled for the spring.i live in the northeast,and i now there is not going to be one here till the faa or winter.

 

[Sunnyinsd]

I'm on the dex trial, had a check up yesterday and heard nothing about cancellation. But I was asked to sign a new form acknowledging side effects mainly skin disturbances I did have hives when I began.

 

[Alyoop]

They are not canceling the current study, just postponing the new one.

 

[HelenL]

My study site was surprised they haven't heard anything yet about starting the trial, and thinks that it's probably due to different data being looked at, and they may be rewriting the protocols... and I have to sign a new form next time I go in as well.

Anyone having a funny feeling in their ears? Not ringing or anything, but more like a feeling of fullness or itchiness inside them?

 

[Sunnyinsd]

Regarding dex trial and ears, I have a stuffy feeling in one ear only. I assumed it was just another feature of ALS. who knows?

 

[frankb]

Re. funny feeling in ear. I have this problem perhaps twice per month. The audiologist did not find anything remarkable. Perhaps drainage ? Re. Dex trial cancellation. Had my six month checkup last week and the very informed research nurse said that clinics had not yet been chosen for the trial. No mention of the IIIb trial being cancelled.

 

[Whitsend]

I'm not in the dex trial and have the issues with one ear. So probably not due to the drug.

 

[Georgia Peach]

I swear the side effect of Dex for my husband is a rosy complexion. Not complaining but we see no reduction or slow down of progression.

 

[momap53]

I sometimes have the feeling of ear congestion but attribute it to allergies. Since winter seems to have bypassed us this year here in SE GA we're already seeing pollen.

 

[Alyoop]

Something that may be helpful
The FDA does not approve a drug that has not had 2 phase 3 studies. That ensures robust and reliable results
The reasons for the next phase 3 study being on hold could be because of concern about the interim analysis of the first study. Either poor efficacy or unforeseen adverse events. They should have sorted the doses out in the phase 2 studies so I doubt that they are disorganized enough to get the dose wrong

 

[frankb]

One thing positive since being on the Dex trial: My unstable handwriting has improved ! ! !

 

[marypat]

i asked about phaseIII 2 and was told they were rewritting protocols, but not positive about which ones. also the ear stuffiness, could be sinus, or weak muscles around the tubes or weak muscles in the nasophangyl (back of the throat/nasal cavity) area.