Method for treating tension type headaches or headaches associat

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

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514929, A61K 31405

Patent

active

053766725

DESCRIPTION:

BRIEF SUMMARY
This invention relates to a new medical use for a certain indole derivative and pharmaceutical compositions containing it. In particular it relates to the use of 3-[2-(dimethylamino)-ethyl]-N-methyl-1H-indole-5-methanesulphonamide and physiologically acceptable salts and solvates thereof in treating certain types of headache.
3-[2-(dimethylamino)-ethyl]-N-methyl- 1H-indole-5-methanesulphonamide, which may be represented by the formula ##STR1## and its physiologically acceptable salts and solvates are disclosed in UK Patent Specification No. 2162522.
The compounds disclosed in the aforementioned patent specification are described as useful in treating and/or preventing pain resulting from dilatation of the cranial vasculature, in particular migraine and related disorders such as cluster headache.
We now find that the compound of formula (I) is also of use in the treatment of tension-type headache and headache associated with substances or their withdrawal. The exact mechanisms of tension-type headache are not known although involuntary tightening in muscles induced mentally or physically is important as are purely psychogenic mechanisms such as stress. Exposure to or withdrawal from certain substances is also known to cause headache. Drugs having a vasoconstrictor effect used in the treatment of migraine arc not generally applicable in the treatment of tension-type headache or headache associated with substances or their withdrawal, which are conventionally treated by administration of simple analgesics such as aspirin and paracetamol. Surprisingly, the compound of formula (I) is effective in the relief of such headaches.
According to one aspect of the invention we therefore provide the compound of formula (I) ##STR2## or a physiologically acceptable salt or solvate thereof for use in the treatment or prevention of tension-type headache or headache associated with substances or their withdrawal.
In an alternative or further aspect, the invention provides a method of treatment of a mammal, including man, suffering from or susceptible to tension-type headache or headache associated with substances or their withdrawal which comprises administering an effective amount of the compound of formula (I) or a physiologically acceptable salt or solvate thereof.
It will be appreciated that whilst the compound of formula (l) will primarily be of use in the alleviation of established symptoms, prophylaxis is not excluded.
In a further aspect, the invention provides the use of the compound of formula (I) or a physiologically acceptable salt or solvate thereof in the manufacture of a medicament for the treatment or prevention of tension-type headache or headache associated with substances or their withdrawal.
A further aspect of the invention provides pharmaceutical compositions for the treatment or prevention of tension-type headache or headache associated with substances or their withdrawal comprising as active ingredient a compound of formula (I) or a physiologically acceptable salt or solvate thereof.
Categories of headaches referred to herein are defined according to the classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain produced by the Headache Classification Committee of the International Headache Society, Cephalgia 1988, 8 suppl. 7:1-96.
The classification of tension-type headache embraces both chronic headaches (more than 15 days per month) and episodic headaches. Such headaches may be associated or unassociated with disorder of pericranial muscles.
The classification of headache associated with substances or their withdrawal embraces headache induced by acute or chronic substance use or exposure and headache associated with substance withdrawal after acute or chronic use. Headaches may be induced, for example, by the use of or exposure to substances such as alcohol, carbon monoxide, monosodium glutamate, analgesics and nitrates or nitrites. Headaches may also be induced by withdrawal from certain drugs, for example narcotics, alcohol, caffeine and ergotamine. Use of

REFERENCES:
patent: 4636521 (1987-01-01), Coates
patent: 4816470 (1989-03-01), Dowle et al.
patent: 4894387 (1990-01-01), Butina et al.
patent: 5037845 (1991-08-01), Oxford
Buzzi et al., Br. J. Pharmacol., 99, 1990, pp. 202-206.
Diener et al., Headache, 31(4), 1991, pp. 205-209.
Den Boer, J. Neurol., suppl. 1, 238, 1991, pp. S28-S35.

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