WO2000032178A2 - Use of siburamine for the treatment of disorders of the central nervous system secondary to organic impairments - Google Patents

Use of siburamine for the treatment of disorders of the central nervous system secondary to organic impairments Download PDF

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Publication number
WO2000032178A2
WO2000032178A2 PCT/US1999/028362 US9928362W WO0032178A2 WO 2000032178 A2 WO2000032178 A2 WO 2000032178A2 US 9928362 W US9928362 W US 9928362W WO 0032178 A2 WO0032178 A2 WO 0032178A2
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WO
WIPO (PCT)
Prior art keywords
disorder
disorders
sibutramine
symptoms
treatment
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Ceased
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PCT/US1999/028362
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English (en)
French (fr)
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WO2000032178A3 (en
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Peter Sterling Mueller
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Priority to JP2000584874A priority Critical patent/JP2003504303A/ja
Priority to AU17488/00A priority patent/AU764049B2/en
Priority to EP99960633A priority patent/EP1135115B1/en
Priority to CA002353133A priority patent/CA2353133C/en
Priority to DE69931957T priority patent/DE69931957T2/de
Publication of WO2000032178A2 publication Critical patent/WO2000032178A2/en
Publication of WO2000032178A3 publication Critical patent/WO2000032178A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/08—Antiepileptics; Anticonvulsants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system

Definitions

  • 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; and opiate narcotic addiction.
  • 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 THE INVENTION
  • 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.
  • Pharmacologic therapy has included low doses of dopamine-2 blockers and dopamine-antagonists including haloperidol, risperidone, or pimozide. T.M.
  • Violence or rage can also be categorized as an impulse control disorder. There is a loss of control grossly out of proportion to any precipitating psychosocial stresses. Disabling outbursts of rage and violent behavior can be related to chronic brain syndrome associated with irreversible CNS (central nervous system) lesions. Yudofsky et al., Am. J. Psychiatry 138:218-220, 1981. Disorders characterized by severe episodic dyscontrol can result from brain dysfunction, e.g., resulting from a failure of modulation of electrical disturbances in the limbic system (amygdala, hippocampus, hypothalamus), temporal lobe epilepsy (TLE), brain lesions or injuries which can have neurological side effects.
  • amygdala, hippocampus, hypothalamus central nervous system
  • TLE temporal lobe epilepsy
  • Temporal lobe epilepsy and other organic brain disorders may be associated with various sexual impairments. See, e.g., D.M.Bear, "Temporal Lobe
  • FM is differentiated from CFS by specific point pain spots in the muscles and CFS differs from FM by having a sore throat, tender cervical or axillary lymph nodes, variably elevated erythrocyte sedimentation rate, occasional low grade temperature, and a variety of immunologic or neuroendocrinologic test values (none of which are consistent or indicative of any known etiologic agent) See, e.g., K. Fukuda et al.. Ann. Intern. Med. 121 :953-959, 1994; A. L. Komaroff et al., Rev. Infect. Dis. 13(Suppl. 1):S8-11, 1991. Both are clearly different from a depressive diagnosis. A recent study by A. L. Komaroff et al, Am. J. Med. 101 :281-
  • sibutramine activates endo ⁇ hins or, at the very least, modifies the endo ⁇ hinergic opioid systems to promote serenity and lack of pain and stress, and to reduce craving for heroin.
  • Treatment had included phenytoin, phenobarbital, clonidine, carbamazepine, fenfluramine, magnesium penoline, valproic acid, hydroxyzine, methylphenidate, bromocriptine, clomipramine, desipramine, selegiline, propranolol, clozapine, felbamate, tacrine, gabapentin, risperidone, lamotrigine, olanzapine, donepezil, and quetiapine without any good results.
  • the patient was started on sibutramine 10 mg in the morning and was seen two days after a very severe thunderstorm with the threat of tornadoes. The patient reported she stayed up four hours of that night watching for tornadoes, completely oblivious of her former psychotic fear of thunder.
  • Intracerebral Porencephalic Cyst With Oscillopsia (Problem No. 5) Sibutramine Patient No. 111 A 58-year-old man suffered a severe head injury in 1976 with a fractured skull, coma, and an intracerebral (porencephalic) cyst caused by the traumatic blockage of his cerebral spinal fluid in his brain. This cyst was repaired surgically with a brain ventricular - jugular vein shunt. This had permitted him to work continuously with concomitant treatment with carbamazepine, valproic acid, and dextroamphetamine until early 1998 when he began to suffer severe attacks of seeminglyly altered vision, dizziness, ataxia, and confusion.
  • a 46-year-old married woman with a lifelong history of ADHD was treated for four years with multiple medications including methylphenidate, magnesium pemoline, dextroamphetamine, and long-acting amphetamine salts without success and negative side effects.
  • the amphetamines made her nervous, jittery, and unable to sleep.
  • the methylphenidate and magnesium pemoline on the other hand, made her sleepy.
  • These medications did not calm her hyperactivity without sedating her. She was started on sibutramine 10 mg every morning by mouth. Immediately she noted a calming and an alerting effect not seen with the dopamine agonist analeptics. After the first month, her dose was changed to 5 mg three times daily due to a five hour duration of effects. She has continued on the medication to date (over six months) as did her daughter who also failed to respond to all of the various analeptic dopaminergic drugs used for ADHD.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Epidemiology (AREA)
  • Addiction (AREA)
  • Psychiatry (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Virology (AREA)
  • Communicable Diseases (AREA)
  • Ophthalmology & Optometry (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Psychology (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Oncology (AREA)
  • Reproductive Health (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
PCT/US1999/028362 1998-12-02 1999-12-01 Use of siburamine for the treatment of disorders of the central nervous system secondary to organic impairments Ceased WO2000032178A2 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2000584874A JP2003504303A (ja) 1998-12-02 1999-12-01 器質性障害から派生する障害の治療
AU17488/00A AU764049B2 (en) 1998-12-02 1999-12-01 Treatment of disorders secondary to organic impairments
EP99960633A EP1135115B1 (en) 1998-12-02 1999-12-01 Use of sibutramine for the treatment of disorders of the central nervous system secondary to organic impairments
CA002353133A CA2353133C (en) 1998-12-02 1999-12-01 Treatment of disorders secondary to organic impairments
DE69931957T DE69931957T2 (de) 1998-12-02 1999-12-01 Verwendung von sibutramin zur behandlung von von organischen störungen verursachten zns-erkrankungen

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/204,124 1998-12-02
US09/204,124 US6323242B1 (en) 1998-12-02 1998-12-02 Treatment of disorders secondary to organic impairments

Publications (2)

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WO2000032178A2 true WO2000032178A2 (en) 2000-06-08
WO2000032178A3 WO2000032178A3 (en) 2000-10-05

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PCT/US1999/028362 Ceased WO2000032178A2 (en) 1998-12-02 1999-12-01 Use of siburamine for the treatment of disorders of the central nervous system secondary to organic impairments

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US (2) US6323242B1 (https=)
EP (1) EP1135115B1 (https=)
JP (1) JP2003504303A (https=)
AT (1) ATE329588T1 (https=)
AU (1) AU764049B2 (https=)
CA (1) CA2353133C (https=)
DE (1) DE69931957T2 (https=)
WO (1) WO2000032178A2 (https=)

Cited By (10)

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WO2003039598A1 (en) * 2001-11-05 2003-05-15 Cypress Bioscience, Inc. Selective norepinephrine serotonin reuptake inhibitors for treating fibromyalgia syndrome, chronic fatique syndrome and pain
EP1320360A1 (en) * 2000-09-14 2003-06-25 Sepracor Inc. Methods and compositions for the treatment and prevention of sexual dysfunction
JP2005523334A (ja) * 2002-04-24 2005-08-04 サイプレス バイオサイエンス， インコーポレイテッド ストレス関連障害を含む機能的身体障害の予防および処置
JP2005531594A (ja) 2002-05-30 2005-10-20 ニューロサーチ、アクティーゼルスカブ 慢性苦痛の治療用トリプルモノアミン再取り込み阻害剤
US6992110B2 (en) 2001-11-05 2006-01-31 Cypress Bioscience, Inc. Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain
EP1404308A4 (en) * 2001-04-17 2007-05-02 Snowden Pharmaceuticals Llc TREATMENT OF SECONDARY DISORDERS CAUSED BY ORGANIC DEFICIENCIES
WO2008042773A3 (en) * 2006-09-29 2008-08-28 Pdxrx Inc Unitary pharmaceutical composition, method, and kit for the treatment or prevention of metabolic or endocrine disorders
US7989500B2 (en) 2006-09-15 2011-08-02 Reviva Pharmaceuticals, Inc. Synthesis, methods of using, and compositions of cycloalkylmethylamines
WO2013102195A1 (en) 2011-12-30 2013-07-04 Reviva Pharmaceuticals, Inc. Compositions, synthesis, and methods of using phenylcycloalkylmethylamine derivatives
US8604244B2 (en) 2010-07-02 2013-12-10 Reviva Pharmaceuticals, Inc. Compositions, synthesis, and methods of using cycloalkylmethylamine derivatives

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WO2017168174A1 (en) 2016-04-02 2017-10-05 N4 Pharma Uk Limited New pharmaceutical forms of sildenafil
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EP1320360A1 (en) * 2000-09-14 2003-06-25 Sepracor Inc. Methods and compositions for the treatment and prevention of sexual dysfunction
JP2004529850A (ja) * 2000-09-14 2004-09-30 セプラコア インコーポレーテッド 性機能不全の処置および防止のための方法および組成物
EP1404308A4 (en) * 2001-04-17 2007-05-02 Snowden Pharmaceuticals Llc TREATMENT OF SECONDARY DISORDERS CAUSED BY ORGANIC DEFICIENCIES
US7820643B2 (en) * 2001-11-05 2010-10-26 Cypress Bioscience, Inc. Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain
WO2003039598A1 (en) * 2001-11-05 2003-05-15 Cypress Bioscience, Inc. Selective norepinephrine serotonin reuptake inhibitors for treating fibromyalgia syndrome, chronic fatique syndrome and pain
US6992110B2 (en) 2001-11-05 2006-01-31 Cypress Bioscience, Inc. Methods of treating fibromyalgia syndrome, chronic fatigue syndrome and pain
EP2322225A1 (en) * 2001-11-05 2011-05-18 Cypress Bioscience, Inc. Selective norepinephrine serotonin reuptake inhibitors for treating fibromyalgia syndrome, chronic fatigue syndrome and pain
EP1499309A4 (en) * 2002-04-24 2008-05-28 Cypress Bioscience Inc PREVENTION AND TREATMENT OF FUNCTIONAL SOMATIC DISEASES, INCLUDING STRESS-BASED DISEASES
JP2010070573A (ja) * 2002-04-24 2010-04-02 Cypress Bioscience Inc ストレス関連障害を含む機能的身体障害の予防および処置
JP2005523334A (ja) * 2002-04-24 2005-08-04 サイプレス バイオサイエンス， インコーポレイテッド ストレス関連障害を含む機能的身体障害の予防および処置
JP2005531594A (ja) 2002-05-30 2005-10-20 ニューロサーチ、アクティーゼルスカブ 慢性苦痛の治療用トリプルモノアミン再取り込み阻害剤
US9296681B2 (en) 2006-09-15 2016-03-29 Reviva Pharmaceuticals, Inc. Cycloalkylmethylamines
US7989500B2 (en) 2006-09-15 2011-08-02 Reviva Pharmaceuticals, Inc. Synthesis, methods of using, and compositions of cycloalkylmethylamines
US8338632B2 (en) 2006-09-15 2012-12-25 Reviva Pharmaceuticals, Inc. Cycloalkylmethylamines
US8372883B2 (en) 2006-09-15 2013-02-12 Reviva Pharmaceuticals, Inc. Methods of using cycloalkylmethylamines
US8445714B2 (en) 2006-09-15 2013-05-21 Reviva Pharmaceuticals, Inc. Cycloalkylmethylamines
US9302981B2 (en) 2006-09-15 2016-04-05 Reviva Pharmaceuticals, Inc. Synthesis, methods of using, and compositions of cycloalkylmethylamines
WO2008042773A3 (en) * 2006-09-29 2008-08-28 Pdxrx Inc Unitary pharmaceutical composition, method, and kit for the treatment or prevention of metabolic or endocrine disorders
US9096515B2 (en) 2010-07-02 2015-08-04 Reviva Pharmaceuticals, Inc. Methods of using cycloalkylmethylamine derivatives
US8604244B2 (en) 2010-07-02 2013-12-10 Reviva Pharmaceuticals, Inc. Compositions, synthesis, and methods of using cycloalkylmethylamine derivatives
WO2013102195A1 (en) 2011-12-30 2013-07-04 Reviva Pharmaceuticals, Inc. Compositions, synthesis, and methods of using phenylcycloalkylmethylamine derivatives

Also Published As

Publication number Publication date
AU764049B2 (en) 2003-08-07
DE69931957T2 (de) 2007-01-25
JP2003504303A (ja) 2003-02-04
AU1748800A (en) 2000-06-19
DE69931957D1 (de) 2006-07-27
CA2353133A1 (en) 2000-06-08
US6323242B1 (en) 2001-11-27
US20030207943A1 (en) 2003-11-06
WO2000032178A3 (en) 2000-10-05
EP1135115B1 (en) 2006-06-14
EP1135115A2 (en) 2001-09-26
ATE329588T1 (de) 2006-07-15
CA2353133C (en) 2009-11-03

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