U.S. patent application number 09/731362 was filed with the patent office on 2002-03-14 for composition and method for decreasing neurologic symptomatology.
Invention is credited to Swope, David M..
Application Number | 20020032203 09/731362 |
Document ID | / |
Family ID | 22547826 |
Filed Date | 2002-03-14 |
United States Patent
Application |
20020032203 |
Kind Code |
A1 |
Swope, David M. |
March 14, 2002 |
Composition and method for decreasing neurologic symptomatology
Abstract
A method of decreasing the signs or symptomatology in a patient
with a neurologic condition or disease, or in a patient due to
effects of exposure to an exogenous substance, such as a
pharmaceutical agent, comprising selecting a patient having at
least one sign or symptom selected from the group consisting of
akinesia, bradykinesia, dyskinesias, gait disturbances, posture
disturbances, rigid limbs, speech impairments and tremor and
administering to the patient one or more than one effective doses
of a phosphodiesterase inhibitor. A composition for decreasing the
signs or symptomatology in a patient with a neurologic condition or
disease, or in a patient due to effects of exposure to an exogenous
substance, such as a pharmaceutical agent, the composition
comprising an effective dose of one or more than one
phosphodiesterase inhibitor combined with an effective dose of one
or more than one additional pharmaceutical agent known to decrease
signs or symptomatology in a patient with a neurologic condition or
disease.
Inventors: |
Swope, David M.; (Redlands,
CA) |
Correspondence
Address: |
David A. Farah, M.D.
9th Floor
225 South Lake Avenue
Pasadena
CA
91101
US
|
Family ID: |
22547826 |
Appl. No.: |
09/731362 |
Filed: |
December 5, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09731362 |
Dec 5, 2000 |
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PCT/US00/40901 |
Sep 13, 2000 |
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60153586 |
Sep 13, 1999 |
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Current U.S.
Class: |
514/252.16 ;
514/262.1; 514/263.34 |
Current CPC
Class: |
A61K 31/198 20130101;
A61K 31/415 20130101; A61K 31/40 20130101; A61K 31/52 20130101;
Y10S 514/879 20130101; A61K 31/519 20130101; A61K 31/522 20130101;
Y10S 514/922 20130101; A61K 31/415 20130101; Y10S 514/878 20130101;
A61K 31/522 20130101; A61K 31/198 20130101; A61K 31/40 20130101;
A61K 2300/00 20130101; A61K 31/52 20130101; A61K 2300/00 20130101;
A61K 2300/00 20130101; A61K 2300/00 20130101; A61K 2300/00
20130101; A61K 31/519 20130101; A61K 2300/00 20130101 |
Class at
Publication: |
514/252.16 ;
514/262.1; 514/263.34 |
International
Class: |
A61K 031/522; A61K
031/519 |
Claims
I claim:
1. A method of decreasing the signs or symptomatology in a patient
with a neurologic condition or disease, or in a patient due to
effects of exposure to an exogenous substance, such as a
pharmaceutical agent, the method comprising: a) selecting a patient
having at least one sign or symptom selected from the group
consisting of akinesia, bradykinesia, dyskinesias, gait
disturbances, posture disturbances, rigid limbs, speech impairments
and tremor; and b) administering to the patient one or more than
one effective doses of a phosphodiesterase inhibitor such that the
at least one sign or symptom improves.
2. The method of claim 1, where the patient selected is newly
diagnosed with a neurologic disease or condition.
3. The method of claim 1, where the patient selected has been
taking medication or has had a surgical treatment and is
experiencing dyskinesias.
4. The method of claim 1, where the signs or symptomatology are due
to effects of exposure to levodopa.
5. The method of claim 1, where the condition or disease is
selected from the group consisting of dystonia, Huntington's
Disease, multiple system atrophy, tardive dyskinesias and Tourette
Syndrome.
6. The method of claim 1, where the condition or disease is
Parkinson's Disease.
7. The method of claim 1, where the phosphodiesterase inhibitor is
selected from the group consisting of caffeine, dipyridamole and
theophylline.
8. The method of claim 1, where the phosphodiesterase inhibitor is
sildenafil.
9. The method of claim 1, where administering to the patient one or
more than one effective doses of a phosphodiesterase inhibitor
comprises administering a plurality of doses of the
phosphodiesterase inhibitor.
10. The method of claim 1, where the phosphodiesterase inhibitor is
sildenafil and where the dose of sildenafil administered is between
about 10 mg per day and about 200 mg per day.
11. The method of claim 1, where the phosphodiesterase inhibitor is
sildenafil and where the dose of sildenafil administered is about
50 mg per day.
12. The method of claim 1, where the phosphodiesterase inhibitor is
sildenafil and where the dose of sildenafil administered is about
25 mg per day.
13. The method of claim 1, where administering to the patient one
or more than one effective doses of a phosphodiesterase inhibitor
comprises titrating the dose for the particular patient until the
patient receives the smallest dose that will maximally decrease the
signs or symptomatology without creating unwanted side effects that
outweigh the benefits of the phosphodiesterase inhibitor.
14. The method of claim 1, where administering to the patient one
or more than one effective doses of a phosphodiesterase inhibitor
comprising administering the phosphodiesterase inhibitor for
between about one week and about twenty years.
15. The method of claim 1, where administering to the patient one
or more than one effective doses of a phosphodiesterase inhibitor
comprising administering the phosphodiesterase inhibitor for
between about one year and about five years.
16. The method of claim 1, where administering to the patient one
or more than one effective doses of a phosphodiesterase inhibitor
comprising administering the phosphodiesterase inhibitor
orally.
17. A composition for decreasing the signs or symptomatology in a
patient with a neurologic condition or disease, or in a patient due
to effects of exposure to an exogenous substance, such as a
pharmaceutical agent, the composition comprising an effective dose
of one or more than one phosphodiesterase inhibitor combined with
an effective dose of one or more than one additional pharmaceutical
agent known to decrease signs or symptomatology in a patient with a
neurologic condition or disease.
18. The composition of claim 17, where the phosphodiesterase
inhibitor is sildenafil.
19. The composition of claim 17, where the additional
pharmaceutical agent is selected from the group consisting of an
anticholinergic, a carbidopa/levodopa combination, a dopamine
agonist, a catechol-o-methyl transferase inhibitor, levodopa, a
monoamine oxidase type B inhibitor and an NMDA receptor
antagonist.
20. The composition of claim 17, where the additional
pharmaceutical agent is selected from the group consisting of
amantadine, benztropine, bromocriptine, entacapone, pergolide,
pramipexole, ropinerole, selegiline, tolcapone, and
trihexyphenidyl.
21. The composition of claim 17, where the dose of one or more than
one phosphodiesterase inhibitors is a plurality of doses of a
phosphodiesterase inhibitor.
22. The composition of claim 17, where the dose of one or more than
one additional pharmaceutical agents are doses of a plurality of
pharmaceutical agents.
23. The composition of claim 17, additionally comprising at least
one substance selected from the group consisting of a binding
agent, a coloring agent, an enteric coating and a flavoring
agent.
24. A method of decreasing the signs or symptomatology in a patient
with a neurologic condition or disease, or in a patient due to
effects of exposure to an exogenous substance, such as a
pharmaceutical agent, the method comprising administering the
composition of claim 17 to the patient.
25. A method of treating patients with Parkinson's Disease,
comprising: a) selecting a patient with Parkinson's Disease having
at least one sign or symptom selected from the group consisting of
akinesia, bradykinesia, dyskinesias, gait disturbances, posture
disturbances, rigid limbs, speech impairments and tremor; b)
administering one or more than one effective dose of a
phosphodiesterase inhibitor such that the at least one sign or
symptom improves.
26. The method of claim 25, where administering one or more than
one effective dose of a phosphodiesterase inhibitor comprising
administering a plurality of effective doses of the
phosphodiesterase inhibitor.
27. The method of claim 25, where the phosphodiesterase inhibitor
is sildenafil.
28. The method of claim 27, where the dose of sildenafil is between
about 10 mg per day and 200 mg per day.
29. The method of claim 27, where the dose of sildenafil is 25 mg
per day.
30. The method of claim 27, where the dose of sildenafil is 50 mg
per day.
31. A method of decreasing dyskinesias associated with a neurologic
disease or with exposure to an exogenous substance, comprising: a)
selecting a patient with a dyskinesia from a neurologic disease or
from exposure to an exogenous substance; and b) administering one
or more than one effective dose of a phosphodiesterase
inhibitor.
32. The method of claim 31, where the administration step includes
administering a plurality of effective doses of the
phosphodiesterase inhibitor.
33. The method of claim 31, where the phosphodiesterase inhibitor
administered is sildenafil.
34. The method of claim 33, where the dose of sildenafil is between
about 10 mg per day and 200 mg per day.
35. The method of claim 33, where the dose of sildenafil is 25 mg
per day.
36. The method of claim 33, where the dose of sildenafil is 50 mg
per day.
37. The method of claim 31, where the exogenous substance is a
pharmaceutical agent used to treat Parkinson's Disease.
38. The method of claim 31, where the exogenous substance is
levodopa.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This Application takes priority from U.S. Provisional Patent
Application 60/153,586, filed Sep. 13, 1999 and entitled "Method of
Treating Neurologic Disease," and from PCT Application
PCT/US00/40901, filed Sep. 13, 2000 and entitled "Composition and
Method for Decreasing Neurologic Symptomatology," the contents of
which are incorporated in this disclosure by reference in its
entirety.
BACKGROUND
[0002] Parkinson's Disease is a chronic, progressive,
neurodegenerative disease of unknown cause. It is characterized by
tremor, rigidity, slowness of movement and loss of postural
reflexes. Disability from Parkinson's Disease results from the
progressive impairment of mobility, as well as a form of dementia
that often accompanies the disease.
[0003] Parkinson's Disease is more common in the elderly
population, with a peak incidence between the ages of 55 and 60.
The prevalence of Parkinson's Disease rises with increasing age.
The disease is found worldwide and is estimated to affect 1% of the
population of the United States.
[0004] The primary biochemical abnormality in Parkinson's Disease
is a progressive loss of dopamine producing cells in the substantia
nigra pars compacta area of the brain. These cells are located in
the midbrain and project to the striatum. The cells synapse with
striatal neurons using dopamine as a neurotransmitter. The loss of
dopamine associated with the cell loss results in an imbalance in
the inhibitory and excitatory circuitry in the basal ganglia, and
this in turn results in impairment of movement characteristic of
Parkinson's Disease.
[0005] There is no known cure for Parkinson's Disease, but several
forms of symptomatic treatment are available. These treatments
include medication and surgery.
[0006] The principal goal of symptomatic treatment is to restore
the normal balance of neurotransmitters in the basal ganglia. The
most potent medication available for the treatment of Parkinson's
Disease is levodopa. Levodopa is the biochemical precursor to
dopamine. It can be taken orally and it crosses the blood-brain
barrier where it is taken up by dopaminergic cells in the brain.
Levodopa is then converted to dopamine which is released.
[0007] Levodopa is very effective in ameliorating the symptoms of
Parkinson's Disease during the early stages of the disease.
However, potentially debilitating complications occur with chronic
use of levodopa. For example, chronic use of levodopa causes its
duration of action to progressively decrease, which causes patients
to get cyclical fluctuations of Parkinson's Disease, symptoms known
as "motor fluctuations." Additionally, chronic use of levodopa
causes dyskinesias, which consists of random, purposeless movements
or fixed postures. Such complications afflict approximately 50% of
patients taking levodopa for more than five years.
[0008] The cause of levodopa complications is unknown but appears
to be related to post-synaptic changes due to the pulsatile
delivery of dopamine to the dopamine receptors. Dyskinesias are
particularly difficult to treat. Treatments include adjustment in
levodopa doses to optimize the patient's response. However, while
decreasing the dose reduces the dyskinesias, it usually results in
worsening of the underlying symptoms of Parkinson's Disease.
Amantidine hydrochloride administration is effective in reducing
the duration and severity of dyskinesias in some patients but it is
associated with confusion and nausea, among other side effects.
Further, surgical treatments such as pallidotomy and deep brain
stimulation, are effective treatments for dyskinesias in some
patients but these procedures are expensive and are associated with
surgical complications themselves.
[0009] Therefore, there is a need for a new treatment for
Parkinson's Disease that has fewer complications than current
treatments. Further, there is a need for a new treatment for the
complications associated with levodopa administration such as
dyskinesias.
SUMMARY
[0010] A method of decreasing the signs or symptomatology in a
patient with a neurologic condition or disease, or in a patient due
to effects of exposure to an exogenous substance, such as a
pharmaceutical agent. The method comprises selecting a patient
having at least one sign or symptom selected from the group
consisting of akinesia, bradykinesia, dyskinesias, gait
disturbances, posture disturbances, rigid limbs, speech impairments
and tremor. Then, the patient is administered one or more than one
effective doses of a phosphodiesterase inhibitor such that the at
least one sign or symptom improves.
[0011] In one embodiment, the patient selected is newly diagnosed
with a neurologic disease or condition. In another embodiment, the
patient selected has been taking medication or has had a surgical
treatment and is experiencing dyskinesias. In a preferred
embodiment, the signs or symptomatology are due to effects of
exposure to levodopa.
[0012] In a preferred embodiment, the condition or disease is
selected from the group consisting of dystonia, Huntington's
Disease, multiple system atrophy, tardive dyskinesias and Tourette
Syndrome. In a particularly preferred embodiment, the condition or
disease is Parkinson's Disease.
[0013] In another preferred embodiment, the phosphodiesterase
inhibitor is selected from the group consisting of caffeine,
dipyridamole and theophylline. In a particularly preferred
embodiment, the phosphodiesterase inhibitor is sildenafil.
[0014] In one embodiment, the method comprises administering a
plurality of doses of the phosphodiesterase inhibitor. In a
particularly preferred embodiment, the phosphodiesterase inhibitor
is sildenafil and where the dose of sildenafil administered is
between about 10 mg per day and about 200 mg per day, more
preferably about 50 mg per day and most preferably about 25 mg per
day. In another particularly preferred embodiment, the dose of the
phosphodiesterase inhibitor is titrated for the particular patient
until the patient receives the smallest dose that will maximally
decrease the signs or symptomatology without creating unwanted side
effects that outweigh the benefits of the phosphodiesterase
inhibitor.
[0015] In another embodiment, the phosphodiesterase inhibitor is
administered for between about one week and about twenty years, and
more preferably for between about one year and about five years. In
a preferred embodiment, the phosphodiesterase inhibitor is
administered orally.
[0016] In one embodiment, the present invention is a composition
for decreasing the signs or symptomatology in a patient with a
neurologic condition or disease, or in a patient due to effects of
exposure to an exogenous substance, such as a pharmaceutical agent.
The composition comprises an effective dose of one or more than one
phosphodiesterase inhibitor combined with an effective dose of one
or more than one additional pharmaceutical agent known to decrease
signs or symptomatology in a patient with a neurologic condition or
disease. In a preferred embodiment, the phosphodiesterase inhibitor
is sildenafil. In another preferred embodiment, the additional
pharmaceutical agent is selected from the group consisting of an
anticholinergic, a carbidopa/levodopa combination, a dopamine
agonist, a catechol-o-methyl transferase inhibitor, levodopa, a
monoamine oxidase type B inhibitor and an NMDA receptor antagonist.
The composition can also comprise at least one substance selected
from the group consisting of a binding agent, a coloring agent, an
enteric coating and a flavoring agent.
[0017] The present invention also includes a method of decreasing
the signs or symptomatology in a patient with a neurologic
condition or disease, or in a patient due to effects of exposure to
an exogenous substance, such as a pharmaceutical agent, the method
comprising administering a composition according to the present
invention.
[0018] In another embodiment of the present invention, there is
provided a method of treating patients with Parkinson's Disease.
The method comprises selecting a patient with Parkinson's Disease
and administering one or more than one effective dose of a
phosphodiesterase inhibitor such that the at least one sign or
symptom improves. The one or more than one effective dose of a
phosphodiesterase inhibitor can comprise administering a plurality
of effective doses of the phosphodiesterase inhibitor.
[0019] In a preferred embodiment, the phosphodiesterase inhibitor
is sildenafil. In a particularly preferred embodiment, the dose of
sildenafil administered is between about 10 mg per day and about
200 mg per day, more preferably about 50 mg per day and most
preferably about 25 mg per day.
[0020] In another embodiment of the present invention, there is
provided a method of decreasing dyskinesias associated with a
neurologic disease or with exposure to an exogenous substance, such
as levodopa. The method comprises selecting a patient with a
dyskinesia from a neurologic disease or from exposure to an
exogenous substance, and administering one or more than one
effective dose of a phosphodiesterase inhibitor, such as
sildenafil.
DESCRIPTION
[0021] According to one embodiment of the present invention, there
is provided a method of decreasing the signs or symptomatology in a
patient with a neurologic condition or disease, such as Parkinson's
Disease, or in a patient due to effects of exposure to an exogenous
substance, such as a pharmaceutical agent. The method comprises
selecting a patient with appropriate signs or symptomatology and
administering one or more than one effective dose of a
phosphodiesterase inhibitor, such as sildenafil.
[0022] According to another embodiment of the present invention,
there is provided a composition for decreasing neurologic signs or
symptomatology in a patient with a neurologic condition or disease,
such as Parkinson's Disease, or in a patient due to effects of
exposure to an exogenous substance, such as a pharmaceutical agent.
The composition comprises one or more than one effective dose of a
phosphodiesterase inhibitor, such as sildenafil, and one or more
than one effective dose of another substance effective in
decreasing neurologic signs or symptomatology.
[0023] As used in this disclosure, "signs or symptomatology" means
either signs, or symptomatology, or a combination of signs and
symptomatology.
[0024] According to one embodiment of the present invention, there
is provided a method of decreasing neurologic signs or
symptomatology in a patient with a neurologic condition or disease
or in a patient due to effects of exposure to an exogenous
substance. The method is particularly useful in decreasing
neurologic signs or symptomatology related to movement and balance,
such as akinesia, bradykinesia, gait disturbances, posture
disturbances, rigid limbs, speech impairments and tremor, as well
as dyskinesias associated with long term exposure to pharmaceutical
agents such as levodopa. The method is particularly useful in
decreasing neurologic signs or symptomatology due to diseases and
conditions such as Parkinson's Disease, tardive dyskinesias,
Tourette Syndrome, Huntington's Disease, multiple system atrophy
and dystonia, or subsequent to viral infections, or due to exposure
to an exogenous substance such to MPTP
(1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine) or to pharmaceutical
agents used to treat neurologic diseases, such as levodopa. The
method can also be used to treat other diseases and conditions
which have similar signs or symptomatology as Parkinson's
Disease.
[0025] The method comprises, first, selecting a patient having
appropriate signs or symptomatology. The patient can be newly
diagnosed with a neurologic disease or condition, or have been
previously diagnosed with a neurologic disease or condition. In a
preferred embodiment, the patient has been previously diagnosed
with a neurologic disease or condition, has been taking medication
or has had a surgical treatment for the neurologic disease or
condition, and has still experienced signs or symptomatology or has
had unwanted side effects of the medication or surgery, such as
dyskinesias.
[0026] The patient is then administered one or more than one
effective dose of a phosphodiesterase inhibitor. In a preferred
embodiment, the phosphodiesterase inhibitor is selected from the
group consisting of caffeine, dipyridamole and theophylline. In a
particularly preferred embodiment, the phosphodiesterase inhibitor
is sildenafil (Viagra.RTM., available from Pfizer, Inc., New York,
N.Y. US).
[0027] In another preferred embodiment, the method includes
administering a plurality of doses of the phosphodiesterase
inhibitor. In a particularly preferred embodiment, the
phosphodiesterase inhibitor is sildenafil and the dose of
sildenafil administered is between about 10 mg per day and about
200 mg per day, and more preferably the dose is 25 mg per day.
However, as will be understood by those with skill in the art with
reference to this disclosure, the dose should be titrated for the
particular patient until the patient receives the smallest dose
that will maximally decrease the signs or symptomatology without
creating unwanted side effects that outweigh the benefits of the
phosphodiesterase inhibitor.
[0028] In another preferred embodiment, the phosphodiesterase
inhibitor is administered for between about one week and about
twenty years. In a particularly preferred embodiment, the
phosphodiesterase inhibitor is administered for between about one
year and about five years.
[0029] In a preferred embodiment, the phosphodiesterase inhibitor
is administered orally, though other routes of administration are
also within the scope of this invention, including administration
by skin patch, subcutaneous injection, inhaled preparations and
direct intravenous administration.
[0030] In a particularly preferred embodiment, the method of the
present invention comprises administering a plurality of doses of a
composition according to the present invention. The composition
comprises an effective dose of one or more than one
phosphodiesterase inhibitor, such as sildenafil, and an effective
dose of one or more than one other pharmaceutical agents that is
effective in decreasing neurologic signs or symptomatology. In a
particularly preferred embodiment, the one or more than one other
pharmaceutical agents is an agent know to decrease dyskinesias
associated with a neurologic disease or associated with the
exposure to an exogenous substance.
[0031] According to another embodiment of the present invention,
there is provided a composition for decreasing the signs or
symptomatology in a patient with a neurologic condition or disease,
such as Parkinson's Disease, or in a patient due to effects of
exposure to an exogenous substance, such as a pharmaceutical agent.
The composition comprises an effective dose of one or more than one
phosphodiesterase inhibitor combined with an effective dose of one
or more than one additional pharmaceutical agent known to decrease
signs or symptomatology in a patient with a neurologic condition or
disease. In a preferred embodiment, the additional pharmaceutical
agent is selected from the group consisting of an anticholinergic,
a carbidopa/levodopa combination, a dopamine agonist, a
catechol-o-methyl transferase inhibitor, levodopa, a monoamine
oxidase type B inhibitor and an NMDA receptor antagonist. Examples
of suitable anticholinergics are trihexyphenidyl (available as
Artane.RTM. from Lederle Pharmaceutical Division, Pearl River, N.Y.
US), and benztropine (available as Cogentin.RTM. from Merck and
Co., West Point, Pa. US). Examples of suitable carbidopa/levodopa
combinations are Sinemet.RTM. and Sinemet.RTM. CR, (both from Merck
and Co., West Point, Pa. US). Examples of suitable dopamine
agonists are pramipexole (available as Mirapex.RTM. from Pharmacia
and Upjohn Co., Kalamazoo Mich. US), ropinerole (available as
Requip.RTM. from SmithKline Beecham Pharmaceuticals, Philadelphia
Pa. US), pergolide (available as Permax.RTM. from Athena
Neurosciences Inc., San Francisco Calif. US) and bromocriptine
(available as Parlodel.RTM. from Novartis Pharmaceuticals, Inc.,
East Hanover, N.J. US). Examples of suitable catechol-o-methyl
transferase inhibitors are tolcapone (available as Tasmar.RTM. from
Roche Pharmaceuticals, Nutley, N.J. US) and entacapone (available
as Comtan.RTM. from Novartis Pharmaceuticals, Inc., East Hanover,
N.J. US). An example of a suitable monoamine oxidase type B
inhibitor is selegiline (available as Eldepryl.RTM. from Somerset
Pharmaceuticals, Inc., Tampa, Fla. US). An example of a suitable
NMDA receptor antagonist is amantadine (available as Symmetrel.RTM.
from Endo Pharmaceuticals Inc., Chadds Ford, Pa. US).
[0032] In a preferred embodiment, the composition comprises
effective doses of a plurality of phosphodiesterase inhibitors, or
effective doses of a plurality of other pharmaceutical agents, or
both effective doses of a plurality phosphodiesterase inhibitors
and effective doses of a plurality of other pharmaceutical
agents.
[0033] In another preferred embodiment, the effective dose of the
one or more than one other pharmaceutical agents is the same as the
dose that would be given if the pharmaceutical agent was not
combined with the phosphodiesterase inhibitor. In a particularly
preferred embodiment, the effective dose of the one or more than
one other pharmaceutical agent is between about one tenth and about
ninth tenths of the dose that would be given if the pharmaceutical
agent was not combined with the phosphodiesterase inhibitor. In
another particularly preferred embodiment, the effective dose of
the one or more than one other pharmaceutical agent is about one
half of the dose that would be given if the pharmaceutical agent
was not combined with the phosphodiesterase inhibitor.
[0034] As will be understood by those with skill in the art with
reference to this disclosure, the composition of the present
invention can also comprise one or more than one additional
substances, such a binding agent, a coloring agent, an enteric
coating and a flavoring agent. The composition is preferably
configured to be administered orally. However, it can also be
configured to be administered by skin patch, subcutaneous
injection, inhaled preparations or direct intravenous
administration, among other routes, as will be understood by those
with skill in the art with reference to this disclosure.
EXAMPLE I
[0035] Method for Decreasing Neurologic Symptomatology
[0036] A 60 year old, Caucasian, male patient who had Parkinson's
Disease for twelve years and who suffered from severe dyskinesia
affecting all his extremities and his head and neck for five years
was treated with the method for decreasing neurologic
symptomatology according to the present invention. Before beginning
treatment according to the present method, the patient was taking
700 mg of levodopa per day. The patient was initially treated with
50 mg of sildenafil per day. During treatment, his dyskinesias were
significantly reduced and his dose of sildenafil was decreased to
25 mg of sildenafil and his dose of levodopa was reduced to between
300 and 400 mg per day. The patient's signs and symptoms of
Parkinson's Disease remain significantly improved after more than
one year of treatment according to the present method.
EXAMPLE II
[0037] Method for Decreasing Neurologic Symptomatology
[0038] A 55 year old, Caucasian, male patient who had Parkinson's
Disease for fifteen years and who suffered from tremor at rest and
gait disturbance was treated with the method for decreasing
neurologic symptomatology according to the present invention.
Before beginning treatment according to the present method, the
patient was taking levodopa 500 mg per day. The patient was
initially treated with 25 mg of sildenafil per day. After five
months of treatment, his tremor had ceased and his gait disturbance
had improved significantly and his dose of sildenafil was increased
to 25 mg three times per day and his dose of levodopa was decreased
to 250 mg per day. The patient's signs and symptoms of Parkinson's
Disease remain significantly improved after more than seven months
of treatment.
EXAMPLE III
[0039] Method for Decreasing Neurologic Symptomatology
[0040] Seven additional patients with Parkinson's Disease and
dyskinesias were treated with sildenafil at a dose of 25 mg per day
in addition to their usual Parkinson's Disease medications. The
patents were all Caucasian and ranged in age from between 55 to 70
years. Four of the patients were men and three were women. Five of
the seven patients had significant improvement in their dyskinesias
using a dose the 25 mg per day. None of the patients demonstrated
any significant side effects of sildenafil treatment or any
worsening of their Parkinson's Disease symptoms, though one did
report facial flushing.
[0041] Although the present invention has been discussed in
considerable detail with reference to certain preferred
embodiments, other embodiments are possible. Therefore, the scope
of the appended claims should not be limited to the description of
preferred embodiments contained herein.
* * * * *