Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Patent
1996-04-30
1997-03-18
Henley, III, Raymond
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
A61K 31165
Patent
active
056123795
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a new use in therapeutics of modafinil.
Modafinil or benzhydrylsulphinyl acetamide is a compound of formula: ##STR1##
This compound and its therapeutic application as an agent which is active with respect to the central nervous system have been described in Patent Application FR-A-2,385,693. This application describes pharmacological properties showing waking and antidepressant pharmacological effects. Very favourable results are mentioned for the treatment of asthenias in elderly people. The product is furthermore described as useful in the treatment of tardive dyskinesias of neuroleptics. Application FR-A-2,663,225 describes therapeutic properties which are useful in the treatment of neurodegenerative diseases of the dopaminergic pathways of the central nervous system, such as Parkinson's disease. Moreover, French Patent Application 91 15 534 describes properties which are useful in the treatment of sequel of cerebral ischaemic accidents.
It has now been discovered that modafinil has a beneficial effect with respect to apneas occurring during sleep apnea syndromes.
The subject of the present invention is consequently the use of modafinil for the manufacture of a medicament having a beneficial effect on the occurrence of the apneas which characterize sleep apnea syndromes, and more generally ventilatory disorders of central origin.
The anti-apnea medicament containing modafinil can be presented in particular in a form suitable for oral administration. Generally, the dose administered can be from 1 mg/kg to 100 mg/kg.
It will be recalled that an apnea is defined as an interruption of the nasobuccal airflow exceeding a duration arbitrarily set at 10 seconds (Guilleminault C., Tilkian A., Dement W C.: Ann. Rev. Med., 1976, 27: 465-484). Three types of apnea are to be distinguished: apneas of central origin, apneas by obstruction of the airways, and apneas, known as mixed apneas, combining the two central and obstructive causes. Sleep apnea syndromes are conventionally defined by an apnea number greater than 5 apneas per hour of sleep. More recently, the syndromes are defined by an apnea and hypopnea number greater than 10 events per hour of sleep.
The result of a clinical trial demonstrating the anti-apnea effects of modafinil in man will be given below.
6 subjects, of both sexes, monitored in a specialist hospital department and suffering from sleep apnea syndrome of central and mixed origin were included in a single-blind pilot clinical trial comparing the effect of modafinil with the usual treatments such as CIPAP. The patients were diagnosed by a polysomnographic recording method comprising the identification of the sleep stages and the measurement of the duration of each stage, the detection of apneas and the measurement of the consequences of these apneas on the arterial gasometric parameters, the heart rate and the arterial pressure. Identification of the sleep stages was carried out using electroencephalographic (EEG), electromyographic (EMG) and electro-oculographic (EOG) recordings. Ventilatory activity was determined using thermistors. Oxygen saturation of haemoglobin was measured by transcutaneous oximetric measurement. Finally, the other gasometric parameters were measured using an automatic gas analyser of Corning type. Clinical signs such as diurnal somnolence and the quality of nocturnal sleep were assessed using a clinical assessment scale and a sleep diary filled in by the patient and the clinical investigator. Modafinil was administered during the day, preferably in the morning and at the beginning of the afternoon.
The results unexpectedly report an effect on the number of nocturnal apneas occurring during sleep and hypopnea. This number significantly decreases in 4 subjects out of 6 after 1 month of treatment and, in one subject out of 6, the apneas disappear completely from the recordings after treatment. The improvement relating to the number of apneas occurring during sleep seems to persist for several days after interruption of the treatment. The moda
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patent: 4177290 (1979-12-01), Lafon
patent: 5180745 (1993-01-01), Lafon
patent: 5281607 (1994-01-01), Stone et al.
patent: 5391576 (1995-02-01), Lafon
Henley III Raymond
Laboratoire L. Lafon
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