Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
2002-03-06
2004-02-24
Jones, Dwayne C. (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
active
06696495
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to the pharmacological treatment of various secondary neurological, behavioral and cognitive symptoms or disorders emanating out of brain or systemic impairments, i.e., primary impairments.
The secondary symptoms and disorders include as non-limiting examples, tic and behavioral disorders including Tourette's syndrome and severe non-Tourette's motor or vocal tics; Posttraumatic Stress Disorder (PTSD); atypical attention deficit disorder with or without hyperactivity; frontal lobe defects of executive function; oscillopsia; self-mutilation; violence or rage such as in intermittent explosive disorder; asocial behavior; sexual disorders (including gender choice difficulties or hyposexuality); psychological (psychosis, violence, and confusion) and motor symptoms of Huntington's Disease (Huntington's Chorea); fatigue, exhaustion, sleep problems, and pain of Chronic Fatigue Syndrome with or without Fibromyalgia; psychosis with multiple hallucinations and delusions secondary to brain injury; opiate narcotic addiction; Sick Building Syndrome (SBS); Gulf War Syndrome (GWS); Reflex Sympathetic Dystophy Syndrome (RSDS), also known as Complex Regional Pain Syndrome (CRPS); Retinitis Pigmentosa (RP); Cerebral Palsy; Torticollis; Dystonia; Dyskinesia; Institutionalization Syndrome, also known as Concentration Camp Syndrome or Survivor Syndrome; and Dementia, Alzheimer's dementia or non-Alzheimer's dementia. It should be noted that a symptom is a single manifestation while a disorder involves more than one symptom or a cluster of symptoms.
The symptoms and disorders are secondary to the primary impairments and emanate from neurological diseases or brain lesions including Tourette's Disease, non-Tourette's tic disorders, Asperger's Syndrome, temporal lobe or other focal epilepsy, Huntington's Disease, brain tumors or cysts, systemic lupus erythematosus, viral infections and their resulting neurological injuries, and various psychological disorders such as multiple personality disorder, borderline personality, organic psychosis, and severe traumatic experiences.
BACKGROUND OF RELATED TECHNOLOGY
Gilles De La Tourette's syndrome is characterized by motor and vocal tics, i.e., involuntary, sudden, rapid, recurrent, nonrhythmic, stereotyped motor movement or vocalization. Some researchers hypothesize that there is a dysregulation in presynaptic dopamine function in Tourette's disorder (T.D.) and tics can be exacerbated by drugs that enhance synaptic dopamine function. R. T. Madison et al.,
Am. J. Psychiatry
152(9):1359-1361, 1995. Pharmacologic therapy has included low doses of dopamine-2 blockers and dopamine-antagonists including haloperidol, risperidone, or pimozide. T. M. Hyde et al.,
JAMA
273: 498-501, 1995. A problem with this dopamine-2 blockade is that this may often produce decreased attention, hyperactivity, dysphoria, and extrapyramidal symptoms in T.D. patients. Furthermore, if T.D. patients are treated with dopamine-2 stimulating analeptics (such as methylphenidate, dextroamphetamine, or pemoline) for their cognitive, attention, and hyperactivity problems, their motor and vocal tics are intensified. Non-Tourette's tic disorder most commonly arises out of previous analeptic treatment and persists after such treatment.
Dystonia is a neurological movement disorder characterized by involuntary muscle contractions which force certain parts of the body into abnormal, sometimes painful, movements or postures. Dystonia can affect any part of the body including the arms and legs, trunk, neck, eyelids, face or vocal cords. Dystonia is the third most common movement disorder after Parkinson's Disease and Tremor, affecting more than 300,000 people in North America. Currently, no medication or therapy can prevent progression of Dystonia from happening. Dystonia will usually stabilize within five years of onset, but symptoms may fluctuate and stressful situations, anxiety or depression may make symptoms temporarily worse. Treatments currently available not only fail to cure this disorder but only moderately abate the symptoms of Dystonia.
One form of Dystonia is Torticollis which is a neurological movement disorder in which the muscles controlling the neck undergo repetitive or sustained contraction, causing the neck to involuntarily jerk, twist or rotate. The abdominal posture caused by Torticollis is often debilitating and painful. Torticollis most commonly begins between age 30-60, and it affects 83,000 people in the United States. There are three types of torticollis: tonic, sustained abnormal posture; clonic, jerky head movements; and mixed, a combination of tonic and clonic movements. Symptoms progress over two to five years and then remain steady, but may worsen during stressful times. There is no cure for Torticollis. The current treatment provides only temporary relief of symptoms for a short time period before new treatment is needed. Torticollis is also referred to as spasmodic wryneck, idiopathic cervical Dystonia, ICD, cervical Dystonia and spasmodic Torticollis.
Dyskinesia is the impairment of muscle movement, or lack of control over ordinary muscle movement. Typical dyskinetic movements are Chorea, rapid movements; or Dystonia, twisting movements, muscle cramps and unusual posturing. Lingual, facial and tardive dyskinesia is characterized by twitching of the face and tongue, and involuntary movements of the body and limbs. Dyskinesia tends to occur more in people with early onset of Parkinson's disease (before 50 years old). There is no known cure for dyskenesia.
Posttraumatic Stress Disorder (PTSD) follows exposure to a traumatic experience involving actual or threatened death or injury or threat to the physical integrity of oneself or others. PTSD includes characteristic symptoms of reexperience, avoidance of stimuli associated with the trauma, and numbing of general responsiveness or hyperarousal (sleep difficulty, anger, difficulty concentrating, hypervigilance or exaggerated startle response) with clinically significant distress or impairment. Studies in the United States demonstrate that 5 to 6 percent of men and 10 to 14 percent of women had had PTSD at some time in their lives, making it the fourth most common psychiatric disorder. It has been established that PTSD is associated with organic changes in the limbic system. It has also been suggested that a kindling model or a model of a paroxysmal disorder is applicable to PTSD (S. Liper et al.,
Psychosomatics
27 (12): 849-854, 1986). In the kindling model (R. M. Post et al,
Clin. Neuropharmacol.
2:25-42, 1977), cumulative bioelectric changes, especially in the limbic area and secondary to repeated biochemical or psychological stress, can result in abnormal limbic or neuronal sensitization and major psychiatric disturbances. Recent neuroanatomical studies have identified alterations in two major brain structures—the amygdala and hippocampus—in patients with PTSD. The reactivity of the amygdala and anterior paralimbic region to trauma-related stimuli is increased, and the reactivity of the anterior cingulate and orbitofrontal areas decreased. These areas of the brain are involved in fear responses. Differences in hippocampal function and in memory processes presumed to be dependent on the hippocampus have been found, suggesting a neuroanatomical substrate for the intrusive recollections and other cognitive problems that characterize PTSD (R. Yehuda,
N Engl J Med
346 (2): 108-113, 2002). The finding of shrinkage in the hippocampus suggests a loss of cell mass. The loss is not yet known, but may be due to the effects of heightened levels of cortisol, a steriod hormone secreted by the brain in response to emergencies, some researchers believe. Cortisol is a major means the body uses, with adrenaline, to arouse itself so quickly, but it can be toxic and damaging to the hippocampus (D. Goleman,
Science,
C3, Aug. 1, 1995). Pharmacologic therapy for stress disorders has included benzodiazepines (e
Hoffmann & Baron , LLP
Jones Dwayne C.
Snowden Pharmaceuticals, LLC
LandOfFree
Treatment of disorders secondary to organic impairments does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Treatment of disorders secondary to organic impairments, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Treatment of disorders secondary to organic impairments will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3325044