Table 1.
Demographic and disease characteristics at baseline according to Trial Groupa
| PLACEBO (Group A) (N = 11) | MINOCYCLINE (Group B) (N = 21) | |
|---|---|---|
| Male sex, n (%) | 6 (54·5) | 10 (47·6) |
| Age, yr | 12·09 ± 6·12 | 12·48 ± 6·08 |
| Genetic disorder n (%) | ||
| Deletion chromosome 15 | 11 (100) | 19 (90·5) |
| Disomy | 0 | 2 (9·5) |
| Symptoms | ||
| Seizures, n (%) | 11 (100) | 20 (95·2) |
| Abnormal sleep | 7 (63·6) | 3 (14·3) |
| Concomitant medication use, n (%) | ||
| Antiepileptic Drugs | 11 (100) | 19 (90·5) |
| Number of antiepileptics/day | 1·36 ± 0.50 | 1.32 ± 0.58 |
| Benzodiazepines/Anxiolytics | 6 (54·5) | 10 (47·6) |
| Botulinum toxin | 1 (9·1) | 4 (19·0) |
| Melatonin | 8 (72·7) | 9 (42·9) |
| Physical therapy and cognitive stimulationb | ||
| Behavior therapy, n (%) | 7 (63·6) | 15 (71·4) |
| Hours per week | 2·67 ± 2·10 | 2·75± 1·75 |
| Logopedic therapy, n (%) | 8 (72·7) | 18 (85·7) |
| Hours per week | 1·64 ± 1·02 | 2·50 ± 1·24 |
| Physiotherapy, n (%) | 10 (90·9) | 19 (90·5) |
| Hours per week | 1·94± 0·95 | 2·42± 1·16 |
| Hydrotherapy, n (%) | 7 (63·6) | 12 (57·1) |
| Hours per week | 1·71± 0·48 | 1·50± 0·67 |
| CGI-S rated by the neuropediatrician, n (%) | ||
| 1 = Normal | 0 | 0 |
| 2 = Borderline mentally ill | 0 | 0 |
| 3 = Mildly ill | 0 | 0 |
| 4 = Moderately ill | 7 (63·6) | 14 (66·7) |
| 5 = Markedly ill | 4 (36·4) | 4 (19·0) |
| 6 = Severely ill | 0 | 3 (14·3) |
| 7 = Most extremely ill patients | 0 | 0 |
aPlus–minus values are mean ± SD. There were no significant differences among the two groups in any of the baseline characteristics
bAll patients were undergoing special education programs, which contain may differ based on age and on regional policies. Results presented in the table refer to supplementary activities to those local programs