PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND STUDY, PARALLEL-GROUP, MULTI-CENTER TRIAL ASSESSING THE EFFECTS OF ESCALATING DOSES OF BF2.649 AND BF2.649 ADD ON MODAFINIL ON CATAPLEXY IN PATIENTS WITH NARCOLEPSY(HARMONY II”) - Harmony II

• 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: EUCTR2008-007845-29-HU
• Lead Sponsor: Bioprojet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-10
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Males and females of any ethnic origin, 18 to 65 years of age (inclusive).
2. De novo patients i.e. with newly diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy. Patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
3. Partial or total cataplexy attacks with a frequency of at least 5 per week during a 14-day baseline period and Epworth Sleepiness Scale (ESS) score ? 14/24 at the end of baseline period (V2).
4. The patient has expressed a willingness to participate in and complete the study, and signed and dated informed consent prior to beginning protocol required procedures.
5. Females must be surgically sterile or 2 years postmenopausal. Females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Patients using steroidal contraceptives at micro or mini doses (including oral contraceptive, skin patch, tablets and vaginal cream, intrauterine devices) should be advised of the risk of breakthrough bleeding and unintended pregnancy due to the possible reduction of effectiveness of these contraceptives during concomitant therapy with Modafinil. Alternative or additional methods of contraception are necessarily recommended during and for one month after the discontinuation of Modafinil treatment. Females should not be breast-feeding patient.
6. 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).
7. 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).
8. The patient should be assured by appropriate security system

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) no
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. Patients who are unable or unwilling to temporarily discontinue non authorized drugs or substances.
3. 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).
4. Any significant abnormality in the physical examination or clinical laboratory results (e.g. liver or kidney function deficiency).
5. Any significant serious abnormality of the cardiovascular illness e.g. recent myocardial infarction, angina, hypertension or dysrhythmias (within the prior 6 months), Electrocardiogram Bazett’s corrected QT interval (QT x ? [60/HR]) strickly higher than 450 ms, history of left ventricular hypertrophy or mitral valve prolapse.
6. Patients with Severe hepatic Impairment (e.g. prothrombin ratio < 50% or factor V < 50% for patients receiving anti-vitamin K medication) 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.
7. 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.
8. Prior severe adverse reactions to CNS stimulants.
9. Known hypersensitivity to the tested treatment including active substance and inactive excipients.
10. 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.
11. 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