Table 2. Adverse eventsa.
| Side effect | Pooled placebo | 40 mg q.d. | 40 mg b.i.d. | 40 mg t.i.d. | Pooled active | Pooled placebo |
|---|---|---|---|---|---|---|
| (n=6) N (%) | (n=6) N (%) | (n=6) N (%) | (n=6) N (%) | (n=18) N (%) | (n=6) N (%) | |
| Autonomic | ||||||
| Dry mouth | 0 (0%) | 0 (0%) | 2 (33.3%) | 0 (0%) | 2 (11.1%) | – |
| Palpitation | 0 (0%) | 1 (16.7%) | 0 (0%) | 0 (0%) | 1 (5.6%) | – |
| CNS/psychiatric | ||||||
| Headache | 3 (50.0%) | 3 (50.0%) | 3 (50.0%) | 3 (50.0%) | 9 (50%) | 3 (50%) |
| Dizziness | 1 (16.7%) | 0 (0%) | 1 (16.7%) | 4 (66.7%) | 5 (27.8%) | 1 (16.7%) |
| Somnolence | 1 (16.7%) | 3 (50.0%) | 1 (16.7%) | 1 (16.7%) | 5 (27.8%) | 1 (16.7%) |
| Fatigue | 0 (0%) | 1 (16.7%) | 0 (0%) | 0 (0%) | 1 (5.6%) | – |
| Restlessness | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.7%) | 1 (5.6%) | – |
| Poor quality of sleep | 0 (0%) | 1 (16.7%) | 0 (0%) | 0 (0%) | 1 (5.6%) | – |
| Nightmare/vivid dream | 0 (0%) | 1 (16.7%) | 1 (16.7%) | 1 (16.7%) | 3 (16.7%) | – |
| Paresthesia | 0 (0%) | 1 (16.7%) | 0 (0%) | 1 (16.7%) | 2 (11.1%) | – |
| Insomnia | 0 (0%) | 1 (16.7%) | 1 (16.7%) | 1 (16.7%) | 3 (16.7%) | – |
| Irritability | 0 (0%) | 1 (16.7%) | 0 (0%) | 0 (0%) | 1 (5.6%) | – |
| Difficulty concentrating | 1 (16.7%) | 0 (0%) | 0 (0%) | 0 (0%) | – | 1 (16.7%) |
| Hyperthymia | 1 (16.7%) | 0 (0%) | 0 (0%) | 0 (0%) | – | 1 (16.7%) |
| Gastrointestinal | ||||||
| Dyspepsia | 1 (16.7%) | 0 (0%) | 0 (0%) | 0 (0%) | – | 1 (16.7%) |
| Abdominal pain | 1 (16.7%) | 0 (0%) | 0 (0%) | 0 (0%) | – | 1 (16.7%) |
| Nausea | 0 (0%) | 0 (0%) | 0 (0%) | 2 (33.3%) | 2 (11.1%) | – |
| Skin and subcutaneous tissue disorders | ||||||
| Skin pain | 0 (0%) | 1 (16.7%) | 0 (0%) | 0 (0%) | 1 (5.6%) | - |
| Rash | 0 (0%) | 0 (0%) | 0 (0%) | 1 (16.7%) | 1 (5.6%) | - |
Abbreviations: AE, adverse events; CNS, central nervous system; EEG, electroencephalogram.
a
Number of subjects experiencing an AE which were assessed by the Site Investigator as possibly, probably or definitely related to study drug during the trial period. One placebo subject (#601) who was withdrawn on day 8 owing to abnormal EEG and one b.i.d. subject (#607) who withdrew consent on dy 1 for personal reasons are excluded from this table but are included in the Supplementary Table S1.