Phase III: Dexpramipexole

[Alyoop]

Kissj, each study site has their own individual contract with the CRO ( clinical research organization). Travel costs within reason are always provided, but it can be different for each site. Sometimes if a patient has to come from a long distance, and patients are hard to find, the sponsoring company will increase the amount they pay on a casecby case basis. This is probably not the ways with the Dex study as it seems to be recruiting rather well.
They should discuss the travel arrangements at the screening visit, before the consent is signed.
Although it is against trial rules to pay a patientbon a study, they are not supposed to bevout of pocket for attending the study visits. Hence the travel allowance offered.
Make some inquiries if no one has talked to you about it.

When I do a trial budget, I ask for slightly more money than is generally required, for the travel component, so that I can afford to give extra money for patients coming longer distances. I don't give everyone the same amount, but some sites do it differently, using a set amount, and paying out of there trial profits for people living further away.

 

[HelenL]

I was told they'd pay only mileage, but I'm only traveling about 23 miles each way... Even if they paid Sequoia mileage, that would certainly help out. Sue G from Maine might know if they pay for more, she travels to Mass General in Boston as well.

 

[KissJ]

Thanks Alyoop!

 

[Sequoia]

I get $40 bucks each time I visit and they did say they would reimburse me for airfares....fresno is small town and I think they needed me in the Trial. So that is good news for me.

 

[HelenL]

going for my month 4 appt tomorrow in Boston... I thought it was month 5 but not!

 

[Sequoia]

Good luck Helen at your 4th appointment! I just got back from my two week checkin after being on the drug.....everything checked out A-ok. I just have a little bit of nausea. I go to my ALS Clinic today, which I am not looking forward to because I am tired and I just got checked in fresno.
O well, persevere!

 

[susanf]

I go tomorrow for the dexi check. Hour drive each way. bleh

 

[HelenL]

Hi Susan and Sequoia, I went today, had all good numbers I guess. At least my breathing had good numbers, I think my strength tests are a little down from the original. They always have trouble finding a good vein, even though I drink tons of water. I have to go to the clinic on Friday, and same feeling as you Sharon, don't feel like it! But since I finally had another EMG, guess I should show up (especially since I cancelled my Aug appt, so haven't been there since June I think!)

 

[tdodson]

Monday was Mom's 2 month Dex checkup. Breathing was down from 76% to a 71%. Muscle strength was about the same. I think her right arm was better but not a miracle. The first muscle test was done when her shoulder was frozen and now it has gotten a bit better. Since starting the trail her swallowing has gotten worse. Not sure how to bring up PEG in conversation but I think that is something that she needs to get fairly soon.
Hopefully the trial person will get everything set so Mom won't have to go back again to the 3rd month visit. Home visit didn't happen on month 1 with us. It is a 3 hour drive from my parents house to Vandy for the trial. 6 hours in a car is too long for a day when you have to do all of those tests, even for a person without ALS.
No mention of compensation yet. It isn't a big deal but it would be nice to help cover gas there and back.
Good luck to everyone else.
Todd

 

[HelenL]

Todd, call or email your site's coordinator and tell them to sign you up for the travel expenses, I believe it will be retroactive. With 3 hours of driving, at least you can pay for the darn gas and maybe buy lunch. My home visits have been a bit screwed up as well, your site should be sending you home with a kit, and a backup kit for the blood draws. Have them send you those as well, my first one was sent fediagnosed, and now they send me home with the kits.

 

[KissJ]

Hubby seemed to be progressing. Seems to be stable now. Maybe he has the real deal! Prayin.

 

[susanf]

Dexi visit went well. Breathing was the same as first visit. Some muscles were stronger some a little weaker that the visit in Aug. They said it was even and they were happy with the results. We get the real stuff this September. I still have a gut feeling it's the placebo.
I mentioned reimbursement and they are putting in for it ($300) with all the visits.
I mentioned the home health nurse blew a vein on me and was purple up and down my arm for a week. They said there have been several complaints about the same thing with other patients she had. I hate to complain but other nurses do just fine drawing blood. She was way to quick.

 

[KissJ]

Hubby has lots of neusea...the drug...hoping! Praying. Trying to get him to eat better. He doesn't feel like eating, then takes the pills he has without food. Not a good move.

 

[StillSteve]

I've entered information relating to my two-month clinic visit

I showed overall improvements in strength measurements, though I really don't know if they are significant of anything in particular.

My FVC test number declined from 90% to 86%, but I'm dealing with a upper respiratory track infection or allergies (not sure which). My "sniff test" best number rose from 101% to 115%.

One interesting note was that I was told that 4 of 13 patients at my location had shown "spikes" in their blood glucose levels. I am one of the four and was asked to fast before this visit so they can get a reliable number. I don't know yet what my number was yesterday, but my four previous results were 97, 87, 93 and 150.

Has anyone else been told that his or her glucose level has risen?

-- Steve

 

[HelenL]

Well the good news is that I think I have the real drug, since my WBC count is a bit down... the bad news is that my WBC count is down... they haven't said anything to me (yet), so hoping it stays stable. It is 3.74 and normal is 3.80-10.7. If it goes down too far, I'll be out of the trial I think.

I think my glucose in my blood may be up a little bit, but then again, I do like my dark chocolate! It was 101 at last week's blood test, which is 1 over their "high" mark. The glucose in the urine was normal. I'm not sure what my numbers were at my initial screening, I'm going to call for those results to be emailed to me.