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 |