Table 2.
Number of patients with at least one TEAE when on pitolisant as monotherapy or combined with narcolepsy co-medication at least once during the trial (safety population)
| Parameter | Patients on pitolisant monotherapya N = 48 |
Patients with additional anti-narcolepsy treatmentb N = 54 |
Between-group test |
|---|---|---|---|
| All TEAEs (treatment related or not) | 20 (41.7) | 38 (70.4) | 0.003 |
| Headache | 4 (8.3) | 8 (14.8) | |
| Insomnia | 4 (8.3) | 5 (9.3) | |
| Weight increase | 3 (6.3) | 5 (9.3) | |
| Anxiety | 3 (6.3) | 4 (7.4) | |
| Depression | 1 (2.1) | 4 (7.4) | |
| Irritability | 0 (0.0) | 4 (7.4) | |
| Nausea | 2 (4.2) | 3 (5.6) | |
| Vertigo | 1 (2.1) | 3 (5.6) | |
| Vomiting | 2 (4.2) | 2 (3.7) | |
| Treatment related TEAEs | 14 (29.2) | 29 (53.7) | 0.012 |
| Psychiatric disorders | 7 (14.6) | 13 (24.1) | |
| Insomnia | 3 (6.3) | 5 (17.2) | |
| Irritability | 0 (0.0) | 4 (13.8) | |
| Anxiety | 2 (4.2) | 3 (10.8) | |
| Nervous system disorders | 3 (6.3) | 11 (20.4) | |
| Headache | 3 (6.3) | 6 (20.7) | |
| Investigations (weight increase or decrease) | 3 (6.3) | 6 (11.1) | |
| Weight increasedc | 3 (6.3) | 4 (13.8) | |
| Gastrointestinal disorders | 5 (10.4) | 1 (1.9) | |
| Severe TEAEs (treatment related or not) | 6 (12.5) | 9 (16.7) | 0.553 |
| Serious TEAEs (treatment related or not) | 2 (4.2) | 5 (9.3) | 0.442 |
| TEAEs leading to treatment withdrawal (treatment related or not) | 9 (18.8) | 10 (18.5) | 0.976 |
| TEAEs leading to treatment withdrawal (treatment-related) | 7 (14.6) | 4 (7.4) |
Data are number of patients (%) or p-value. Significant p-values are bolded.
aPatients who did not take any concomitant psychostimulant or anti-cataplectic agent.
bPatients who received concomitant psychostimulant (modafinil, methylphenidate, or mazindol) and/or anti-cataplectic (sodium oxybate, SSRIs, or clomipramine) agent.
cBetween 2% and 12% of body weight.