A Phase 3 Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy

INTERVENTION: Product Name: Pitolisant, Product Code:PRD13987418, Pharmaceutical Form: TABLET, Other descriptive name: , Strength: , Product Name: Pitolisant, Product Code:PRD13987419, Pharmaceutical Form: TABLET, Other descriptive name: , Strength: , Product Name: Pitolisant, Product Code:PRD13987417, Pharmaceutical Form: TABLET, Other descriptive name: , Strength: , Product Name: Placebo will be provided as round, biconve Xenteric‐coated tablets matching CCI of HBS‐301. The CCI tablets are beige to light brown. The tablets are also debossed on 1 side with CCI., Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: Placebo will be provided as round, biconve Xenteric‐coated tablets matching CCI tablets of HBS‐301. The CCI tablets are blue‐green. he tablets are also debossed on 1 side with CCI., Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: "Placebo will be provided as round, biconve Xenteric‐coated tablets matching CCI tablets of HBS‐301. The CCI tablets are blue‐violet. he tablets are also debossed on 1 side with CCI., Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A CONDITION: narcolepsy ; MedDRA version: 20.0Level: PTClassification code: 10028713Term: Narcolepsy Class: 100000004852 Therapeutic area: Diseases [C] ‐ Nervous System Diseases [C10] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of HBS‐301 compared with placebo in treating excessive daytime sleepiness (EDS) Primary end point(s): Change in severity of EDS as measured by the ESS from Baseline to the end of the Double‐blind Treatment Period Secondary Objective: 1. To evaluate the efficacy of HBS‐301 compared with placebo in treating cataplexy, 2. To evaluate the efficacy of HBS‐301 compared with placebo in treating sleepiness/wakefulness, 3. To evaluate the efficacy of HBS‐301 compared with placebo in treating CCI, 4. To evaluate the onset of efficacy of HBS‐301 compared with placebo in treating EDS, 5. To evaluate the onset of efficacy of HBS‐301 compared with placebo in treating cataplexy SECONDARY OUTCOME: Secondary end point(s):1. WRC at the end of the Double‐blind Treatment Period in participants with an CCI weeks during Screening Secondary end point(s):2. Change in sleepiness/wakefulness as measured by the MWT from Baseline to the end of the Double‐blind Treatment Period Secondary end point(s):3. Zmiana w CCI mierzona za pomoca CCI od wizyty wyjsciowej do zakonczenia okresu leczenia prowadzonego metoda podw. slepej próby Secondary end point(s):4. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period Secondary end point(s):5. Change in severity of EDS as measured by the ESS from Baseline through CCI of the Titration Period Secondary end point(s):6. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening Secondary end point(s):7. WRC at CCI of the Titration Period in participants with an CCI weeks during Screening INCLUSION CRITERIA: 1. Is able to provide voluntary, written informed consent., 2. Has a current documented diagnosis of NT1 or NT2 per ICSD‐3 or ICSD‐3‐TR criteria with either a confirmatory diagnostic hypocretin level (ICSD‐3‐TR) or PSG with MSLT report on file completed within the last 10 years., 3. Is male or female, =18 years at the time of Screening., 4. CCI., 5. CCI., 6. If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake‐promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double‐blind Treatment Period of the study. Pro re nata (PRN ) use of any treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil) is not permitted., 7. For participants being treated for OSA or other hypoventilatory conditions, participants must be compliant with their medical device or oral appli