Table 2.
Patient Group Assignment, Highest Dose Achieved, and Adverse Events Including Seizures
| Age at enrollment and Gender | Target Dose (mg/day) | 18 mg OROS-MPH (mg/kg) | 36 mg OROS-MPH–day of dose (mg/kg) | 54 mg OROS-MPH -day of dose (mg/kg) | 18 mg placebo | 36 mg placebo-day of dose | 54 mg placebo-day of dose |
|---|---|---|---|---|---|---|---|
| Group 1: Assigned to attempt in random order 1 week 18mg OROS-MPH and 1 week 18mg placebo | |||||||
| 8.3 y.o. F | 18a | C (0.52) | n/a | n/a | C | n/a | n/a |
| 13.8 y.o. M | 18a | C (0.32) | n/a | n/a | C | n/a | n/a |
| 12.5 y.o. M | 18p | C (0.42) | n/a | n/a | C | n/a | n/a |
| Group 2: Assigned to attempt in random order 1 week each 18mg, 36mg OROS-MPH and 1 week each 18mg, 36mg placebo | |||||||
| 17.5 y.o. M | 36p | C (0.22) | nausea - 5 (0.45) | n/a | C | C | n/a |
| 11.0 y.o. F | 36p | C (0.63) | emotional lability - 7 (1.26) | n/a | C | C | n/a |
| 13.6 y.o. F | 36a | C (0.26) | C (0.52) | n/a | C | C | n/a |
| 10.6 y.o. M | 36a | C (0.53) | C (1.06) | n/a | C | C | n/a |
| 6.8 y.o. F | 36a | C (0.86) | overfocus - 5 (1.72) | n/a | C | C | n/a |
| 7.4 y.o. M | 36a | C (0.44) | C (0.88) | n/a | C | C | n/a |
| 10.4 y.o. M | 36p | C (0.33) | C (0.67) | n/a | C | C | n/a |
| 6.8 y.o. M | 36a | C (0.72) | emotional lability - 1 (1.44) | n/a | C | C | n/a |
| 9.0 y.o. M | 36a | C (0.64) | seizure - 4 (1.29) | n/a | C | C | n/a |
| Group 3: Assigned to attempt in random order 1 week each 18mg, 36mg, 54mg OROS-MPH and 1 week each 18mg, 36mg, 54mg placebo | |||||||
| 11.2 y.o. M | 54p | C (0.57) | C (1.14) | tics - 1 (1.71) | C | C | C |
| 12.6 y.o. F | 54p | C (0.32) | C (0.65) | C (0.97) | C | C | C |
| 9.9 y.o. F | 54a | C (0.30) | emotional lability - 6 (0.60) | did not receive | C | C | emotional lability - 2 |
| 6.4 y.o. M | 54a | C (0.61) | insomnia - 6 (1.23) | did not receive | C | C | C |
| 8.3 y.o. F | 54p | C (0.58) | C (1.17) | C (1.75) | C | C | C |
| 17.5 y.o. F | 54a | C (0.26) | seizure - 1 (0.53) | did not receive | C | C seizure - 5 | |
| 16.0 y.o. M | 54p | C (0.21) | C (0.43) | C (0.64) | C | C | C |
| 9.4 y.o. M | 54a | C (0.48) | C (0.95) | C (1.43) | C | C | C |
| 12.4 y.o. F | 54p | C (0.49) | C (0.98) | C (1.47) | C | C | seizure - 5 |
| 8.6 y.o. M | 54a | C (0.66) | C (1.33) | 2 seizures - 1 (2.00) | C | C | seizure - 4 |
| 10.3 y.o. F | 54a | C (0.47) | insomnia - 5 (0.93) | did not receive | C | C | C |
| 7.5 y.o. M | 54a | C (0.62) | C (1.24) | C (1.86) | C | C | C |
| 8.3 y.o. F | 54p | C (0.66) | C (1.33) | C (2.00) | C | C | C |
| 10.5 y.o. M | 54a | C (0.55) | C (1.09) | C (1.64) | C | C | C |
| 12.2 y.o. M | 54p | C (0.41) | C (0.83) | C (1.24) | C | C | C |
| 9.4 y.o. F | 54a | C (0.66) | C (1.32) | C (1.98) | C | C | C |
| 12.2 y.o. M | 54p | C (0.35) | emotional lability -6 (0.69) | did not receive | C | C | C |
| 10.6 y.o. F | 54a | C (0.41) | C (0.81) | C (1.22) | C | C | C |
| 6.4 y.o. M | 54p | seizure - 3 (0.40) | did not receive | did not receive | C | emotional lability - 6 | did not receive |
| 8.2 y.o. M | 54p | C (0.56) | C (1.12) | C (1.68) | C | C | C |
| 12.6 y.o. F | 54p | C (0.33) | insomnia -7 (0.66) | did not receive | C | C | C |
a=first arm of crossover was active OROS-MPH, p=first arm of crossover was placebo, C=completed, n/a=not applicable, AE-X=discontinued due to Adverse Effect (AE) after receiving day X of the OROS-MPH or placebo dose indicated.