The first objective of this study is to demonstrate the efficacy and safety of pitolisant given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS. The secondary objectives of the study include assessing the long-term tolerance as well as the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of Open Label Extension period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Laboratoire du sommeil Clinique de Physiologie, Sommeil et Exercice Pôle Thorax et Vaisseaux CHU de Grenoble
Grenoble, France
Hôpital Gui de Chauliac, CHU Montpellier, Unité des Troubles du Sommeil et de l'Eveil
Montpellier, France
Epworth sleepiness scale (ESS)
Time frame: Change from Baseline of ESS at 12 weeks and Change from Baseline of ESS at 52 weeks
Percentage of ESS responders
Time frame: at week 12 /52 versus baseline
Reduction of sleepiness and sleep episodes on the sleep diary
Time frame: at week 12 /52 versus baseline
Improvement in vigilance according to Oxford Sleep Resistance (OSleR) test
Time frame: at week 12 /52 versus baseline
European Quality of Life Questionnaire (EQ-5D)
Time frame: at week 12 /52 versus baseline
Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: at week 12 /52 versus baseline
The Pichot Fatigue Scale
Time frame: at week 12 /52 versus baseline
Trail Making Test parts (A and B)
Time frame: at week 12 /52 versus baseline
Improvement in Clinical Global Impression (CGI)
Time frame: at week 12 /52 versus baseline
Z-score: composite score including ESS and OSLER results
Time frame: at week 12 /52 versus baseline
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