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 - Harmony I bis

• Conditions: arcolepsy; MedDRA version: 9.1Level: PTClassification code 10028713; MedDRA version: 9.1Level: LLTClassification code 10048322; MedDRA version: 9.1Level: LLTClassification code 10021235; MedDRA version: 9.1Level: PTClassification code 10007737

• Registration Number: EUCTR2010-019687-36-IT
• Lead Sponsor: BIOPROJET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-26
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 135

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 medication at stable dose 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 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 protocol required procedures. 6. Females must be surgically sterile or 2 years postmenopausal. Females of child-bearing potential must use a medically accepted effective method of birth control (i.e. oral contraceptives of normal average dosage ? 0.05 mg ethinyl-oestradiol, intra-uterine device, with a barrier method such as spermicides…), agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding patient. 7. In the opinion of the investigator, the patient must have adequate support to comply with the entire study requirements as described in the protocol (e.g., transportation to and from trial site, self rating scales and diaries completion, drug compliance, scheduled visits, tests). 8. If indicated by investigator, the patient must be willing to not operate a car or heavy machinery for the duration of the trial or as long as the investigator deems clinically indicated. In addition, the patient should be willing to maintain during the study their usual behaviour which could affect their diurnal sleepiness (e.g. circadian rhythm, caffeine consumption, nocturnal sleep duration). 9. Patient should be assured by appropriate healthy insurance system (only applicable where mandatory e.g. in France).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The use of BF2.649 or any previous investigational drugs within 30-day period prior to initial screening visit (V1) for this trial. 2. In narcoleptic patients without cataplexy, they should not have any other conditions that can be considered the primary causes of EDS: such as sleep related breathing disorders as defined by a sleep Apnea Index = 10 per hour or and an Apnea/Hypopnea Index = 15 per hour, periodic limbs movement (PLM) disorders as defined by a PLM arousal index (PLMAI) = 10 per hour, shift work, chronic sleep deprivation, circadian sleep wake rhythm disorder or any other medical or neurological causes that could account for narcolepsy symptoms associated with EDS. 3. Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances (see Section Non-authorized treatments). 4. Current or recent (within one year) history of a substance abuse or dependence disorder including alcohol abuse as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-IV). 5. Any significant serious abnormality of the cardiovascular system e.g. recent myocardial infarction, angina, hypertension or dysrhythmia (within the prior 6 months), Electrocardiogram Bazett’s corrected QT interval (QT x ? [HR/60]) higher than 450 ms, history of left ventricular hypertrophy or mitral valve prolapse. 6. Patients with severe depression (BDI13 = 16) or with a suicidal risk (item G BDI13 > 0) 7. Patients with Severe hepatic Impairment (e.g. prothrombin ratio, < 50% or factor V < 50% if the patient receiving anti-vitamin K) or with Severe Renal Impairment (e.g. serum creatine greater than 2.0 mg/dL), or with any other significant abnormality in the physical examination or clinical laboratory results. 8. Psychiatric and neurological disorders, such as moderate or severe 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 and completion of this trial or comprise reliable representation of subjective symptoms. 9. Prior severe adverse reactions to CNS stimulants. 10. Known hypersensitivity to the tested treatment including active substance and excipients. 11. The inability to continue daily activities safely, without the use of treatment against EDS. 12. Other active clinically significant illness, including unstable cardiovascular, endocrine, neoplastic, gastrointestinal, hematologic, hepatic, immunologic, metabolic, neurological (other than narcolepsy/cataplexy), pulmonary, and/or renal disease which could interfere with the study conduct or counter-indicate the study treatments or place the patient at risk during the trial or compromise the study objectives. 13. Any patients presenting congenital galactosemia, glucose-galactose malabsorption or lactase deficiency due to the presence of lactose in investigational treatments 14. Patients participating in another study or being in a follow–up period for another study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • Evaluate the efficacy and safety of BF2.649 administered until the dose of 20 mg after a titration period and followed by a 5-week stable dose 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 the study treatment discontinuation after an 8-week period of daily medication.;Secondary Objective: ;Primary end point(s): Daytime sleepiness is assessed using the Epworth Sleepiness Scale (ESS).