The Harmony I study showed a significant reduction in the cataplexy rate from baseline to final visit (baseline >0.6 cataplectic episodes versus final visit <0.2 episodes in the pitolisant group; RR=0.38, 95% CI [0.16 to 0.93]; p =0.034), whereas Harmony Ibis showed an increasing trend (0.84 episodes from baseline compared with 1.69 episodes at the final visit in the pitolisant group with no statistically significant difference versus placebo p =0.077).
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Profile of pitolisant in the management of narcolepsy: design, development, and place in therapy.
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