Table 4.
Cataplexy change between baseline and M12 in the pitolisant monotherapy and co-medications for narcolepsy subgroups (ITT population – LOCF)
| Subgroups (Concomitant treatments) | Pitolisant+stimulants (n = 11) (modafinil, methylphenidate, mazindol) | Pitolisant+Anti-cataplectics (n = 7) (sodium oxybate, SSRIs, clomipramine) | Pitolisant+stimulants and anti-cataplectics (n = 4) (modafinil, methylphenidate, mazindol, SSRIs) | Pitolisant monotherapy (n = 21) (No additional narcolepsy treatment) | ||||
|---|---|---|---|---|---|---|---|---|
| Generalized CTP | Partial CTP | Generalized CTP | Partial CTP | Generalized CTP | Partial CTP | Generalized CTP | Partial CTP | |
| Baseline | ||||||||
| Mean nb cataplexies per day (SE) | 0.12 (0.07) | 0.25 (0.16) | 0.08 (0.05) | 0.83 (0.48) | 0.09 (0.18) | 0.97 (0.86) | 0.56 (0.48) | 0.98 (1.0) |
| Final (12-month) | ||||||||
| Mean nb of cataplexies per day (SE) | 0.00 (0.00) | 0.26 (0.15) | 0.00 (0.00) | 0.43 (0.33) | 0.04 (0.02) | 0.23 (0.06) | 0.16 (0.15) | 0.24 (0.17) |
| Change from baseline | ||||||||
| Mean nb of cataplexies per day (SE) 95% CI |
−0.12 (0.07) [−0.29; 0.06] |
0.02 (0.01) [−0.22; 0.25] |
−0.08 (0.14) [−0.21; 0.05] |
−0.40 (1.69) [−1.96; 1.16] |
−0.05 (0.07) [−0.39; 0.28] |
−0.74 (0.26) [−1.87; 0.40] |
−0.41 (0.72) [−1.30; 0.48] |
−0.74 (0.27) [−1.92; 0.43] |
| Variation | −100% | +4% | −100% | −48% | −66% | −77% | −71.5% | −75.5% |