Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy (Harmony1)

Bioprojet

Status and phase: Completed; Phase 3

Conditions: Sleep Disorders; Cataplexy; Excessive Daytime Sleepiness; Narcolepsy

Treatments: Drug: BF2.649; Drug: Placebo; Drug: Modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT01067222

2008-007866-46 (EudraCT Number)

P07-03 / BF2.649

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and safety of BF2.649 administered by individual titration in narcoleptic patients with excessive daytime sleepiness (EDS)

Full description

BF 2.649, a new experimental drug, significantly decreases, in patient with narcolepsy, the excessive daytime sleepiness (EDS) evaluated by Epworth Sleepiness Scale (ESS), according the results of two previous clinical studies.

The objective of this study is to determine the efficacy and safety of BF2.649 administered by escalating dose (10, 20 or 40 mg/d) in narcoleptic patients with excessive daytime sleepiness versus placebo and Modafinil as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.

60 patients with narcolepsy with or without cataplexy will be included.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of narcolepsy with or without cataplexy
• patients need to free of or discontinue psychostimulant medications for at least 14 days,
• patients with severe cataplexy are permitted to remain on their anticataplectic medications at stable doses
• patients must have adequate support to comply with the entire study requirements

Exclusion criteria

• Other conditions than Narcolepsy that can be considered as the primary causes of excessive daytime sleepiness
• Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
• Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
• Current or recent history of a substance abuse or dependence disorder including alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

110 participants in 3 patient groups, including a placebo group

BF2.649

Experimental group

Treatment:

Drug: BF2.649

Modafinil

Active Comparator group

Treatment:

Drug: Modafinil

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo