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Results tables
Results tables
Table 6 Dauvilliers et al. 2013
|
Pitolisant |
Modafinil |
Placebo |
Analysis |
|
|
n (ITT) a |
31 |
33 |
30 |
|
|
Primary outcome |
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|
Mean change from baseline in ESS score after 8 weeks |
−5.8 from baseline of 17.8 |
−6.9 from baseline of 18.5 |
−3.4 from baseline of 18.9 |
Pitolisant versus placebo (superiority test); mean difference: −3.0 (95% CI −5.6 to −0.4), p=0.024 Pitolisant versus modafinil (non-inferiority test); mean difference: 0.12 (95% CI −2.5 to 2.7), p=0.250, NSb |
|
Selected secondary outcomes |
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|
MWT (minutes) |
Baseline: 7.4 Final: 9.7 Changec: 1.32 |
Baseline: 8.8 Final: 15.1 Changec: 1.72 |
Baseline: 8.4 Final: 7.6 Changec: 0.88 |
Pitolisant versus placebo; ratio: 1.47 (95% CI 1.01 to 2.14), p=0.044 Pitolisant versus modafinil; ratio: 0.77 (95% CI 0.52 to 1.13), p=0.173, NS |
|
SART-total score |
Baseline: 12.5 Final: 10.0 Changec: 0.8 |
Baseline: 11.6 Final: 10.4 Changec: 0.89 |
Baseline: 11.5 Final: 11.4 Changec: 1.0 |
Pitolisant versus placebo; ratio: 0.80 (95% CI 0.64 to 1.00), p=0.053, NS Pitolisant versus modafinil; ratio: 0.90 (95% CI 0.71 to 1.14), p=0.370, NS |
|
Safety and tolerability outcomes |
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|
n |
31 |
33 |
30 |
|
|
Participants with adverse events |
71% (22/31) |
79% (26/33) |
33% (10/30) |
No analysis reported |
|
Participants with serious adverse events |
3% (1/31) |
15% (5/33) |
0 |
No analysis reported |
|
Abbreviations: CI, confidence interval; ESS, Epworth Sleepiness Scale; ITT, intention to treat analysis; MWT, maintenance of wakefulness test; n, number of participants; NS, not significant; p, p value; SART, sustained attention to Response task. a The intention to treat population included all participants who had at least 1 dose of study medication and at least 1 post-baseline assessment. One person withdrew consent after randomisation in the pitolisant group. b Non-inferiority was not shown based on the pre-specified non-inferiority margin of 2 points. c Change calculated as final/baseline. |
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Table 7 Szakacs et al. 2017
|
Pitolisant |
Placebo |
Analysis |
|
|
n (ITT) a |
54 |
51 |
|
|
Primary outcome |
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|
Mean change in average number of cataplexy attacks per week after 7 weeks (weekly cataplexy rate) |
Baseline: 9.15 Final: 2.27 Changeb: 0.25 |
Baseline: 7.31 Final: 4.52 Changeb: 0.62 |
Pitolisant versus placebo; rate ratio: 0.51 (95% CI 0.44 to 0.60), p<0.0001 |
|
Selected secondary outcomes |
|||
|
Mean change from baseline in ESS score after 7 weeks |
−5.4 from baseline of 17.4 |
−1.9 from baseline of 17.3 |
Pitolisant versus placebo; mean difference: −3.48 (95% CI −5.03 to −1.92), p=0.0001 |
|
MWT (minutes) |
Baseline: 3.54 Final: 6.91 Changeb: 1.95 |
Baseline: 4.08 Final: 4.32 Changeb: 1.06 |
Pitolisant versus placebo; ratio: 1.85 (95% CI 1.24 to 2.74), p=0.003 |
|
Safety and tolerability outcomes |
|||
|
n |
54 |
51 |
|
|
Participants with adverse events |
35% (19/54) |
31% (16/51) |
p=0.528 |
|
Participants with severe adverse events |
2% (1/54) |
0 |
No analysis reported |
|
Abbreviations: CI, confidence interval; ESS, Epworth Sleepiness Scale; ITT, intention to treat analysis; MWT, maintenance of wakefulness test; n, number of participants; p, p value. a The intention to treat population included all participants who had at least 1 dose of study medication and at least 1 post-baseline assessment. One person did not receive treatment in the placebo group. b Change calculated as final/baseline. |
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