Trial Profile
Randomized, Double-blind, Placebo and Comparator-controlled, Parallel-group, Multi-center Trial Assessing the Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 12 Apr 2022
Price :
$35
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At a glance
- Drugs Pitolisant (Primary) ; Modafinil
- Indications Catalepsy; Narcolepsy
- Focus Therapeutic Use
- Acronyms Harmony-I-bis
- Sponsors Bioprojet
- 27 Apr 2021 According to a Harmony Biosciences media release, data from three analyses; two featuring analyses of efficacy and safety data from the clinical development program for WAKIX in adult patients with narcolepsy and the third a post hoc analysis evaluating the time to onset of clinical response for WAKIX will be presented at the 2021 American Psychiatric Association (APA) Annual Meeting.
- 22 Sep 2012 Planned number of patients changed from 180 to 185.
- 18 Jul 2012 New trial record