EJTUNow
Member
- Joined
- Mar 25, 2013
- Messages
- 28
- Reason
- Learn about ALS
- Country
- US
- State
- North Carolina
- City
- Carteret
As an ALS patient this additional delay Seems to ignore many patient's willingness to take prudent risk. I am not searching for an improved acne medication. I urge every patient to help us get this risk/benefit issue revisited by the FDA
"A recent review of the double-blind, aggregate data from BENEFIT-ALS indicated that the actual standard deviation about the primary endpoint (i.e., the change from baseline in the ALS Functional Rating Scale in its revised form) is slightly higher than the estimate used to initially calculate the sample size for the trial. . Consequently, in order to preserve the intended statistical power for the trial, the company is amending the protocol to allow approximately 500 patients to be enrolled. Additional information about BENEFIT-ALS can be found at Home - ClinicalTrials.gov. "
"A recent review of the double-blind, aggregate data from BENEFIT-ALS indicated that the actual standard deviation about the primary endpoint (i.e., the change from baseline in the ALS Functional Rating Scale in its revised form) is slightly higher than the estimate used to initially calculate the sample size for the trial. . Consequently, in order to preserve the intended statistical power for the trial, the company is amending the protocol to allow approximately 500 patients to be enrolled. Additional information about BENEFIT-ALS can be found at Home - ClinicalTrials.gov. "