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

• Conditions: arcolepsy; MedDRA version: 9.1Level: LLTClassification code 10028713Term: Narcolepsy; MedDRA version: 9.1Level: LLTClassification code 10048322Term: Narcolepsy aggravated; MedDRA version: 9.1Level: LLTClassification code 10021235Term: Idiopathic narcolepsy; MedDRA version: 9.1Level: LLTClassification code 10007737Term: Cataplexy; MedDRA version: 9.1Level: LLTClassification code 10048323Term: Cataplexy aggravated

• Registration Number: EUCTR2008-007866-46-DE
• Lead Sponsor: Bioprojet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-17
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 90

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 protocol required procedures.
6. Women must be surgically sterile or 2 years postmenopausal. Females of child-bearing potential must use a medically accepted effective method of birth control. These women must use oral contraceptives containing at least 0.05 mg Ethinyl estradiol since the effectiveness of steroidal contraceptives may be reduced when used with Modafinil. The steroidal contraceptives at micro and mini doses should be excluded. Patients should agree to continue this method for the duration of the study and for one month after thediscontinuation of Modafinil treatment. Women should 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. Patients should be warned that change in treatment as a consequence of inclusion in this study may reduce their ability to drive, as well as his / her impaired ability to operate machinery. 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 behaviours which could affect their diurnal sleepiness (e.g., circadian rhythm, caffeine consumption, nocturnal sleep duration).

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 with severe depression (BDI>=16) or with suicidal risk (item G BDI > 0).
4. Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances (see Section Non-authorized treatments).
5. 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).
6. Any significant serious abnormality of the cardiovascular system e.g. recent myocardial infarction, angina, hypertension or dysrhythmias (within the prior 6 months), Electrocardiogram Bazett’s corrected QT interval (QT x root from [HR/60]) strickly higher than 450 ms, history of left ventricular hypertrophy or mitral valve prolapse.
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, gastroinstinal, 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.

Study & Design

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