Advice
Excluded studies
Excluded studies
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Study reference |
Reason for exclusion |
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Dauvilliers Y (2014) Novel therapeutic approach in narcolepsy: Clinical trials of an antagonist/inverse agonist of the histamine H3 receptor. Journal of sleep research 23: 75 (282) |
Abstract only Duplicate of included study (HARMONY 1) |
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Leu-Semenescu S, Nittur N, Golmard JL et al. (2014) Effects of pitolisant, a histamine H3 inverse agonist, in drug-resistant idiopathic and symptomatic hypersomnia: a chart review. Sleep Medicine 15: 681–7 |
Poor relevance against search terms Not licensed indication |
The European Public Assessment Report (EPAR) for pitolisant states that the narcolepsy development programme included 5 phase III trials, of which HARMONY I and HARMONY Ibis were considered pivotal for the indication in the treatment of narcolepsy with or without cataplexy.
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HARMONY I (NCT01067222) has been completed and published in full (Dauvilliers et al. 2013).
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HARMONY Ibis (NCT01638403) has been completed but has not been published.
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HARMONY III (NCT01399606) was due to complete in October 2016.
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HARMONY IV (NCT01789398) has been completed but has not been published.
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HARMONY CTP (NCT01800045) has been completed and published in full (Szakacs et al. 2017).