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A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Safety and Efficacy of MK-4305 in Patients with Primary Insomnia – Study A

Mise à jour : Il y a 4 ans
Référence : EUCTR2010-018413-30

Femme et Homme

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Extrait

All Main/Primary objectives are MK-4305 high dose compared to placebo, as measured by change from baseline: MAINTENANCE: 1. Mean subjective total sleep time (sTSTm) at Month 1. 2. Wakefulness after persistent sleep onset (WASO) by PSG at Month 1. 3. Mean subjective total sleep time (sTSTm) at Month 3. 4. Wakefulness after persistent sleep onset (WASO) by PSG at Month 3. ONSET: 5. Mean subjective time to sleep onset (sTSOm) at Month 1. 6. Latency to onset of persistent sleep (LPS) by PSG at Month 1. 7. Mean subjective time to sleep onset (sTSOm) at Month 3. 8. Latency to onset of persistent sleep (LPS) by PSG at Month 3. SAFETY: 9. Safety and tolerability of MK-4305 for up to 3 months of treatment.

Critère d'inclusion

  • Primary Insomnia

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