Table 2. Number of patients enrolled in completed pediatric phase 3 epilepsy clinical trials.
Number of patients enrolled (N = 27,587) | Median size of the trial (IQR) | |
---|---|---|
Published trials | 21,123 (77%) (N = 75 trials with available data) | 207 (IQR 97 to 298) |
*20,575 (82%)(N = 74 trials with available data | *206 (IQR 98 to 396) | |
Unpublished trials | 6,464 (23%)(N = 32 trials with available data) | 97.5 (IQR 45 to 286) |
*4,437 (18%) (N = 24 trials with available data) | *85 (IQR 51 to 204) |
*Trial was completed before 2014 (which takes into account the FDAAA deadline to publication of 1 year after completion). FDAAA = Food and Drug Administration Amendments Act of 2007