Table 2.
| Event | RESTORE 28 | RESTORE 19 | |||
|---|---|---|---|---|---|
|
|
|
||||
| Placebo (n = 179) | RTG 600 mg/day (n = 181) | RTG 900 mg/day (n = 178) | Placebo (n = 152) | RTG 1200 mg/day (n = 153) | |
| Central nervous system | |||||
| Dizziness | 6.7 | 17.1 | 26.4 | 13.8 | 40.5 |
| Somnolence | 10.1 | 14.4 | 26.4 | 17.8 | 31.4 |
| Fatigue | 2.8 | 17.1 | 15.2 | 7.9 | 15.7 |
| Confusional state | 0 | 1.7 | 5.1 | 2.0 | 14.4 |
| Headache | 14.5 | 11.0 | 17.4 | 18.4 | 12.4 |
| Dysarthria | 0 | 5.0 | 1.7 | 2.0 | 12.4 |
| Ataxia | NR | NR | NR | 3.9 | 11.8 |
| Vision blurred | 1.7 | 0.6 | 5.1 | 2.6 | 11.8 |
| Tremor | 2.2 | 1.7 | 9.0 | 3.9 | 11.1 |
| Gastrointestinal | |||||
| Nausea | 3.9 | 6.1 | 6.7 | 6.6 | 10.5 |
| Urinary tract | |||||
| Urinary tract infection | NR | NR | NR | 8.6 | 11.8 |
Note:
*
Data presented as percentage of patients in safety population.
Abbreviations: RESTORE, Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy; RTG, Retigabine; NR, not reported in RESTORE 2 because <5%.