notBrad
Senior member
- Joined
- Feb 26, 2015
- Messages
- 632
- Reason
- PALS
- Diagnosis
- 04/2015
- Country
- US
- State
- OR
- City
- The coast of
OK, I go on Tuesday 12/1 for my initial screening for the Tirasemtiv Phase III trial but I check my email today and received this for the NP001 Phase II at Cutter.
<snip>
Dear Brad,
Thanks for your interest in the NP001 study and your patience as we get the study organized.
I am very excited to tell you about this trial.
The purpose of this drug study is to see if the drug NP001 can slow the progression of weakness in ALS. The hope is that NP001 will keep ALS patients stronger for a longer period of time. It is a clinical trial, an experiment, so we don’t know the answer until the trial is completed.
This study will be conducted at about 8 sites across the country. There will be 60 patients total. Each site will have 6 to 10 patients. We expect that most sites will begin enrollment in January. I believe that the site closest to you will be at California Pacific Medical Center in San Francisco.
NP001 is given through a vein in the arm. There is a screening visit to see if you qualify and then you would come back to the clinic within 28 days to start the infusions. Each infusion takes one hour and then you have to stay at the clinic for 2 hours after you finish the infusion. The infusions are given in cycles on consecutive days. You go home each night – this is an outpatient study. The first cycle is 5 days in a row. A month later you come back for 3 days in a row, and then monthly for 3 days in a row for a total of 6 monthly cycles. That would be a total of 20 IV infusions. Finally, you come back a month later to get checked out and exit from the study.
There are criteria that you must meet to get into the study. Some of the main criteria are:
· Diagnosis of ALS.
· ALS weakness started less than 3 years ago at the time you enter the study.
· Good breathing, FVC above 65%.
· Have good veins.
· Not using a machine like BiPAP or CPAP to help you breath at night.
· Not have a feeding tube.
· Not have any other significant illness.
So you can see that this study will be very time consuming and may not be a good fit for everyone. I hope you remain interested in this study and I am happy to answer your questions.
</snip>
Thoughts, advice, etc... ?
Thanks,
Brad
<snip>
Dear Brad,
Thanks for your interest in the NP001 study and your patience as we get the study organized.
I am very excited to tell you about this trial.
The purpose of this drug study is to see if the drug NP001 can slow the progression of weakness in ALS. The hope is that NP001 will keep ALS patients stronger for a longer period of time. It is a clinical trial, an experiment, so we don’t know the answer until the trial is completed.
This study will be conducted at about 8 sites across the country. There will be 60 patients total. Each site will have 6 to 10 patients. We expect that most sites will begin enrollment in January. I believe that the site closest to you will be at California Pacific Medical Center in San Francisco.
NP001 is given through a vein in the arm. There is a screening visit to see if you qualify and then you would come back to the clinic within 28 days to start the infusions. Each infusion takes one hour and then you have to stay at the clinic for 2 hours after you finish the infusion. The infusions are given in cycles on consecutive days. You go home each night – this is an outpatient study. The first cycle is 5 days in a row. A month later you come back for 3 days in a row, and then monthly for 3 days in a row for a total of 6 monthly cycles. That would be a total of 20 IV infusions. Finally, you come back a month later to get checked out and exit from the study.
There are criteria that you must meet to get into the study. Some of the main criteria are:
· Diagnosis of ALS.
· ALS weakness started less than 3 years ago at the time you enter the study.
· Good breathing, FVC above 65%.
· Have good veins.
· Not using a machine like BiPAP or CPAP to help you breath at night.
· Not have a feeding tube.
· Not have any other significant illness.
So you can see that this study will be very time consuming and may not be a good fit for everyone. I hope you remain interested in this study and I am happy to answer your questions.
</snip>
Thoughts, advice, etc... ?
Thanks,
Brad