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• Conditions: arcolepsy with Cataplexy; MedDRA version: 16.0Level: LLTClassification code 10028715Term: Narcolepsy with cataplexySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-003076-39-CZ
• Lead Sponsor: Bioprojet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-02
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 148

Inclusion Criteria

• Men or women, of 18 years of age and over.
• Patients with a diagnosis of narcolepsy with cataplexy according to the International Classification of Sleep Disorders (ICSD-2) criteria
• De novo” patients, or patients treated by purported anticataplectic drugs, i.e. SSRIs and patients treated by sodium oxybate at stable dose, for a minimum period of one month, having shown an incidence of at least 3 weekly cataplexy attacks and with an ESS score = 12
• Patients should be free of prohibited treatments (see p.10) or have discontinued them for at least 7 days at the start of baseline period.
• Women of child-bearing potential must use a medically accepted effective, method of birth control, estimated efficient enough by the investigator, and agree to continue this method for the duration of the study and the month following treatment discontinuation. Women must be negative to serum pregnancy test performed at the screening visit and should not be breast-feeding patients.

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 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• Patients with 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.
• Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as moderate or severe psychosis or dementia, bipolar illness, severe anxiety, clinical severe depression (BDI = 16) with suicidal risk (item G BDI > 0), or depression treated for less than 8 weeks, history of seizure disorder or other problem that, in the investigator’s opinion, would preclude the patient’s participation and completion of this trial.
• Patients unable or unwilling to temporarily suppress non-authorized drugs during the study.
• Concurrent use of hypnotics, tranquilizers, sedating antihistamines, benzodiazepines, anticonvulsants, psychostimulants, (amphetamines, amphetamine-like, modafinil, methylphenidrate, or other CNS stimulants), tricyclic antidepressants (e.g. imipramine), clonidine will not be accepted since 3 weeks before randomisation and during study.
• 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).
• Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology 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 participation.
• Patients with a known history of long QTc syndrome (e.g. syncope or arrhythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), or QTc Fridericia higher than 450 ms for male and 470ms for female
(electrocardiogram Fridericia’s corrected QT interval =QT / 3 (cube root) RR)
• Patients with Severe Hepatic Impairment or with Severe Renal Impairment, or with any other significant abnormality in the physical examination or clinical laboratory results.
•Known hypersensitivity to the tested treatment including active substance and excipients.
• Prior severe adverse reactions to CNS stimulants
• Any patients presenting congenital galactosemia, glucose-galactose malabsorption or lactase deficiency due to the presence of lactose in investigational treatments
• Patients participating in another study, or having participated in a study during the previous month

Study & Design

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