Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Reexamination Certificate
2001-08-30
2003-11-18
Jarvis, William R. A. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
C514S082000, C514S085000, C514S089000, C514S216000, C514S217000, C514S654000
Reexamination Certificate
active
06649605
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method of treatment or prevention of tension-type headache in a human in need of such treatment. In particular, the invention relates to a method of treatment of tension-type headache comprising the administration of an agent or agents effective for the prevention or reduction of central sensitization
GENERAL BACKGROUND
Types of Clearly Defined Headache Disorders
Previously, headache disorders were not clearly distinguished and it was widely believed that they formed part of a continuum and were strongly related. In 1988, The International Headache Society, (IHS) via its ad hoc committee on classification published a document entitled Classification and Diagnostic Criteria for Headache Disorders, Cranial Neuralgias and Facial Pain (Classification and Diagnostic Criteria for Headache Disorders, 1988). A new entity was here defined by name of tension-type headache. This entity was practically the same as conditions previously called tension headache, muscle contraction headache, psycho-myogenic headache and idiopathic headache. The IHS classification also defined a number of other specific headache diseases. Today it therefore gives no meaning to talk about headache in general. It would be the same as to discuss bellyache and chest pain without specifying its type and etiology. Due to the development in diagnostic accuracy research results obtained before 1988 have uncertain validity.
Tension-type headache was subdivided by the IHS Classification Committee into an episodic form occurring less than half of all days and a chronic form occurring half of all days or more. Furthermore, both of these divisions were further subdivided into a form with disorder of pericranial muscle and a form without such disorder. It is thus crucial that research and patents specify which of the subforms are included.
Before the entity of tension-type headache was created, it was widely believed that this kind of headache was caused by muscle ischemia, a concept later disproven by the present inventors (Langemark et al. 1990). The term tension-type headache was created in order to indicate that experts disagreed with the notion of tension-type headache being simply a kind of muscle pain. In fact, the term idiopathic headache was suggested. There is only a moderate co-morbidity with neck pain and low back pain in sufferers of tension-type headache. Furthermore, Electromyography (EMG)-measurements have failed to detect an increase of muscle contraction sufficient to cause pain on a purely mechanical basis in tension-type headache patients whereas central factors such as depression and anxiety have been attributed a significant role. Finally, a genetic factor has recently been shown to be involved in tension-type headache (Østergaard et al. 1996). From the point of view of mechanisms and definition tension-type headache is thus a specific entity which may or may not share mechanisms with muscle pain in the head and in other parts of the body. The classification and diagnostic criteria for tension-type headache are shown in Tables I and II.
TABLE I
Classification of headache disorders cranial neuralgias, and facial pain
(Headache Classification Committee 1988).
1.
Migraine
2.
Tension-type headache
3.
Cluster headache and chronic paroxysmal hemicrania
4.
Miscellaneous headaches unassociated with structural lesion
5.
Headache associated with head trauma
6.
Headache associated with vascular disorders
7.
Headache associated with non-vascular intra-cranial disorder
8.
Headache associated with substances or their withdrawal
9.
Headache associated with noncephalic infection
10.
Headache associated with metabolic disorder
11.
Headache or facial pain associated with disorder of cranium, neck,
eyes, nose, sinuses, teeth, mouth or other facial or cranial
structures
12
Cranial neuralgias, nerve trunk pain and deafferentation pain
13.
Headache not classifiable
TABLE II
Diagnostic criteria for episodic and chronic tension-type
headache (Headache Classification Committee 1988)
II.1. Episodic tension-type headache
A.
At least 10 previous headache episodes fulfilling criteria B-D listed
below.
Number of days with such headache<180/year (<15/month)
B.
Headache lasting from 30 minutes to 7 days
C.
At least 2 of the following pain characteristics:
1.
Pressing/tightening quality
2.
Mild or moderate severity (may inhibit, but does not prohibit
activities)
3.
Bilateral location
4.
No aggravation by walking stairs or similar routine physical
activity
D.
Both of the following:
1.
No nausea or vomiting (anorexia may occur)
2.
Photophobia and phonophobia are absent, or one but not the
other is present
E.
At least one of the following:
1.
History, physical and neurological examinations do not suggest
one of the disorders listed in groups 5-11
2.
History and/or physical and/or neurological examinations do
suggest such disorders, but they are ruled out by appropriate
investigations
3.
Such disorders are present, but tension-type headache does
not occur for the first time in close temporal relation to
the disorder
II.2. Chronic tension-type headache
A.
Average headache frequency 15 days/month (180 days/year) for
6 months fulfilling criteria B-D listed below
B.
At least 2 of the following pain characteristics:
1.
Pressing/tightening quality
2.
Mild or moderate severity (may inhibit, but does not prohibit
activities)
3.
Bilateral location
4.
No aggravation by walking stairs or similar routine physical
activity
C.
Both of the following:
1.
No vomiting
2.
No more than one of the following:
Nausea, photophobia or phonophobia
D.
At least one of the following:
1.
History, physical and neurological examinations do not suggest
one of the disorders listed in groups 5-11
2.
History and/or physical and/or neurological examinations do
suggest such disorders, but they are ruled out by appropriate
investigations
3.
Such disorders are present, but tension-type headache does
not occur for the first time in close temporal relation
to the disorder
Epidemiological studies done by the inventors have shown that chronic tension-type headache affects three per cent of the population at any given time, the lifetime prevalence being as high as six per cent (Rasmussen et al. 1991). Severe episodic tension-type headache defined as persons having headache twice a week or more occurs in approximately ten per cent of the population. Thus, tension-type headache is a
# serious problem with significant socio-economic implications, involving enormous loss of workdays and quality of life.
Epidemiological studies done by the inventors have shown that chronic tension-type headache affects three percent of the population at any given time, the lifetime prevalence being as high as six percent (Rasmussen et al. 1991). Severe episodic tension-type headache defined as persons having headache twice a week or more occurs in approximately ten percent of the population. Thus, tension-type headache is a serious problem with significant socio-economic implications, involving enormous loss of workdays and quality of life.
Previous Findings in General Pain Physiology and Pain Pharmacology
The possible pathogenic mechanisms of tension-type headache have previously been studied and discussed by Langemark et al. (Langemark et al. 1987, 1988, 1989) and by the group of Jean Schoenen (Schoenen et al. 1937, 1991a, b). The latter group have mainly focused on electrophysiological recordings as electromyography, and the jaw opening reflex as reflected by the so-called exteroceptive silent period (ES2) (Schoenen et al. 1987). On the basis of shortened ES2 periods in patients with chronic tension-type headache compared to healthy controls a limbic dysfunction was suggested, but these results have later been disproven by more systematic investigations (Bendtsen et al. 1996a, Lipchik et al 1996, Zwart and Sand, 1996). Schoenen and other groups have also studied mechanical pain thresholds on the extremities as well as in the cranial region and decreased mechanical pain thresholds in severely affected patients with chronic ten
Bendtsen Lars
Jensen Rigmor
Madsen Ulf
Olesen Jes
Cooper Iver P.
Head Explorer A/S
Jarvis William R. A.
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