Prospective, randomized, double-blind study, placebo-controlled, parallel-group, multi-center trial assessing the effects of BF2.649 in treatment of excessive daytime sleepiness in narcolepsy (HARMONY I) - Harmony I

INTERVENTION: Product Code: BF 2.649 Pharmaceutical Form: Capsule* Current Sponsor code: BF2.649 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Code: BF 2.649 Pharmaceutical Form: Capsule* Current Sponsor code: BF2.649 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Modiodal Product Name: Modafinil Product Code: N06BA07 Pharmaceutical Form: Capsule* INN or Proposed INN: Modafinil Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use CONDITION: Narcolepsy ; MedDRA version: 9.1 Level: LLT Classification code 10028713 Term: Narcolepsy ; MedDRA version: 9.1 Level: LLT Classification code 10048322 Term: Narcolepsy aggravated ; MedDRA version: 9.1 Level: LLT Classification code 10021235 Term: Idiopathic narcolepsy ; MedDRA version: 9.1 Level: LLT Classification code 10007737 Term: Cataplexy ; MedDRA version: 9.1 Level: LLT Classification code 10048323 Term: Cataplexy aggravated PRIMARY OUTCOME: Main Objective: • Evaluate the efficacy and safety of BF2.649 administered by escalating doses and followed by 5‐week stable doses in narcoleptic patients with excessive daytime sleepiness (EDS) as compared to placebo.; • Evaluate the efficacy and safety of BF2.649 in treatment of excessive daytime sleepiness in narcolepsy as compared to Modafinil; • Investigate the response to withdrawal of BF2.649 after 8 weeks daily medication. Primary end point(s): Subjective daytime somnolence assessed using Epworth Sleepiness Scale (ESS). ; ESS will be evaluated at baseline and at endpoint corresponding to the end of 8‐week double‐blind phase or to the time of the last on‐study visit for any subject who withdraws prior to study completion. ; Each ESS score corresponds to the average of 2 measures repeated after an interval of 1week. The ESS at baseline is the average of ESS at D‐7 and ESS at D0; the ESS at endpoint V7 is the average of ESS at D49 and ESS at D56.; Secondary Objective: NA INCLUSION CRITERIA: 1. Males and females of any ethnic origin, 18 years old and over. 2. Both new and previously diagnosed patients with narcolepsy with or without cataplexy could be included. All patients should meet the International Classification of Sleep Disorders (ICSD‐2) criteria. 3. Patients should be free of drugs or discontinue any psychostimulant medications for at least 14 days at the start of baseline period. Patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses except tricyclic antidepressants. The authorized anticataplectic treatment should have been administrated for at least 1 month prior to the trial and these doses should not be changed throughout the trial (from V1 to V8). 4. Epworth Sleepiness Scale (ESS) score should be = 14/24 during the baseline period. 5. Patients have expressed a willingness to participate in and complete the study, and signed and dated informed consent prior to beginning pr