Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
Summary
The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy
Description
BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.
The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Narcolepsy
Intervention
BF2.649, BF2.649 add on Modafinil
Location
Neurocenter (EOC) of Southern Switzerland
Lugano
Switzerland
6903
Status
Recruiting
Source
Bioprojet
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01067235
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Narcolepsy
A condition characterized by recurrent episodes of daytime somnolence and lapses in consciousness (microsomnias) that may be associated with automatic behaviors and AMNESIA. CATAPLEXY; SLEEP PARALYSIS, and hypnagogic HALLUCINATIONS frequently accompany narcolepsy. The pathophysiology of this disorder includes sleep-onset rapid eye movement (REM) sleep, which normally follows stage III or IV sleep. (From Neurology 1998 Feb;50(2 Suppl 1):S2-S7)
Methylphenidate
A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.
Hla-b7 Antigen
Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. There is a weak association between the presence of the HLA-B7 antigen and the diseases of narcolepsy and idiopathic hemochromatosis. HLA-B7 is in linkage disequilibrium with HLA-A3 and HLA-DR2.
Hla-dr2 Antigen
Human immune-response, D-related antigen encoded by the D locus on chromosome 6 and found on lymphoid cells. It is in linkage disequilibrium with HLA-A3 and HLA-B7 and is strongly associated with Goodpasture syndrome, multiple sclerosis, and narcolepsy.
Ephedrine
A phenethylamine found in EPHEDRA SINICA. PSEUDOEPHEDRINE is an isomer. It is an alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used for asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists.
Clinical Trials
This study will be conducted as a randomized, double blind, double-dummy, placebo-controlled, parallel-group trial in patients diagnosed with narcolepsy. Volunteers for this trial will be...
A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy
The purpose of this study is to evaluate the safety and effectiveness of JNJ-17216498 compared to modafinil and placebo in patients with narcolepsy, with and without cataplexy.
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolep...
Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sle...
Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy
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)
PubMed Articles
OBJECTIVE: To investigate the effect of modafinil on cortical excitability in patients with narcolepsy using transcranial magnetic stimulation (TMS). METHODS: Nineteen drug-naïve narcolepsy patients...
Neuraxial anaesthesia for caesarean section in a patient with narcolepsy and cataplexy.
We report the management of a morbidly obese parturient suffering from narcolepsy with cataplexy who presented for caesarean section. Her symptoms were controlled by modafinil and fluoxetine. We admin...
Modafinil for narcolepsy: Systematic review and meta-analysis.
Background: To assess the effectiveness and safety of modafinil vs. no active treatment or other drugs in the treatment of narcolepsy. Material/Methods: The following electronic databases were searche...
Modafinil reverses hypoexcitability of the motor cortex in narcoleptic patients: A TMS study.
OBJECTIVE: Although many animal and human studies have been performed, the exact mechanisms of action whereby modafinil promotes wakefulness are still not completely understood. We aimed to investigat...
Recent Advances in the Treatment of Narcolepsy.
OPINION STATEMENT: A diagnosis of narcolepsy requires pharmacologic treatment in more than 90% of patients. Wake-promoting compounds are used to treat excessive daytime sleepiness (EDS), and anticatap...
