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WO2015200322A1 - Procédés de traitement ou de soulagement de la migraine - Google Patents

Procédés de traitement ou de soulagement de la migraine Download PDF

Info

Publication number
WO2015200322A1
WO2015200322A1 PCT/US2015/037177 US2015037177W WO2015200322A1 WO 2015200322 A1 WO2015200322 A1 WO 2015200322A1 US 2015037177 W US2015037177 W US 2015037177W WO 2015200322 A1 WO2015200322 A1 WO 2015200322A1
Authority
WO
WIPO (PCT)
Prior art keywords
migraine
patient
compound
administering
days
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2015/037177
Other languages
English (en)
Inventor
Joseph R. Moskal
Patric STANTON
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Northwestern University
Naurex Inc
Original Assignee
Northwestern University
Naurex Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Northwestern University, Naurex Inc filed Critical Northwestern University
Priority to CA2953170A priority Critical patent/CA2953170A1/fr
Priority to AU2015280108A priority patent/AU2015280108B2/en
Priority to CN201580033913.6A priority patent/CN106661085A/zh
Priority to BR112016030375A priority patent/BR112016030375A8/pt
Priority to KR1020177001848A priority patent/KR20170018072A/ko
Priority to EP15811633.5A priority patent/EP3157943A4/fr
Priority to JP2016575106A priority patent/JP6688748B2/ja
Priority to RU2017101410A priority patent/RU2721401C2/ru
Priority to MX2016017388A priority patent/MX2016017388A/es
Publication of WO2015200322A1 publication Critical patent/WO2015200322A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/07—Tetrapeptides
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401—Proline; Derivatives thereof, e.g. captopril
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • 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
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the central nervous system (CNS) of mammals employs many neuroactive peptides to effect specialized signaling within the brain and spinal cord including the neuroactive peptides somatostatin, choiecystokinm, VIP, Substance P, enkephalin, Neuropeptide Y (NPY), Neurotensin, TRH, CCK, and dynorphin.
  • somatostatin somatostatin
  • NPY Neuropeptide Y
  • Neurotensin TRH
  • CCK dynorphin
  • the disclosure relates to a method of treating, suppressing and/or preventing cortical spreading depression (SD), comprising administering to a patient in need thereof a pharmaceutically effective amount of a GL YX peptide, in certain embodiments, the disclosure relates to treating or ameliorating long-term post migraine sequelae in a patient in need thereof, comprising administering to the patien a pharmaceutic lly effective amount of a GLYX peptide,
  • the invention relates to a method of treating, suppressing, and/or preventing cortical spreading depression in a patient in need thereof, comprising administering to said patient a pharmaceutically effective amount of a compound represented by:
  • FIG. 1 shows focal, high [K r ]-indueed spreading depression (SD) in field CA1 of hippoeampai slices resulting in a change in luminance reflecting the spreading wave of mass depolarization of neurons and glia.
  • Figures 11A-11B show rescue of blast-induced learning deficits by rapastinel (3 mg/kg IV; 1 hour post-blast) in PEL tests 24 hours post-blast.
  • Figure 11A shows blast recovery time (latency to normal ambulation) data.
  • Figure 1 I B shows the results of a single 3 min Positive Emotional Learning (PEL) test session conducted 24 hours post-blast using a between subjects design.
  • N 4-6 per group. * P ⁇ 0.05 ( Figure 11A) A OVA, or ( Figure 1 IB) fisher's PLSD post hoc test, rapastinel ⁇ TBI vs. vehicle + TBI.
  • Probable migraine describes conditions that have some characteristics of migraines, but where there is not enough evidence to diagnose it as a migraine with certainty (in the presence of concurrent medication overuse).
  • Chronic migraine is a complication of migraines, and is a headache that fulfills diagnostic criteria for migraine headache and occurs for a greater time interval. Specifically, greater or equal to 15 days/month for longer than 3 months.
  • GLYX peptide refers to a peptide haying NMDAR glycine-site partial agonist/antagonist activity. GLYX peptides may be obtained by well-known recombinant or synthetic methods such as those described in US Patents 5,763,393 and 4,086,196 herein incorporated by reference. In some embodiments, GLYX refers to a tetrape tide having the amino acid sequence Thr-Pro-Pro-Thr, or L-threonyl-L-prolyl-L-prolyl- L-ihreonine amide.
  • GLYX-13 may act predominantly at NR2B-containing MDARs, and may not display the classic side effects of known NMDAR modulators such as CPC- 101,606 and ketamine.
  • an anti-migraine or other therapeutic effect with essentially no sedation may be produced by GLYX-13 when administered to a subject in therapeutically effective amounts.
  • GLYX-13 may not have abuse potential (e.g., may not be habit-forming).
  • GLYX-13 may increase AMPA GluRl serine-845 phosphorylation.
  • glycogen synthase kinase 3 ⁇ (GSK- ⁇ ) may be activated by GLYX-13.
  • levels of ⁇ -catentn may be altered after administration of GLYX-13.
  • a migraine sufferer that has, or is at risk of, any of these conditions may take medications to treat or to manage these diseases, and these medications may adversely interact with currently used medications for the treatment of migraine with aura.
  • some of these conditions are contraindications for triptan therapy (e.g., stroke and sumatriptan therapy).
  • the FDA issued a public health advisory in 2006 regarding serotonin syndrome, a life-threatening condition that may occur whe a triptan is used together with certain anti-depressants that are serotonin reuptake inhibitors (SSRls) or selective serotonin/norepinephrine reuptake inhibitors (SNRls). Accordingly, the methods described herein may be useful for the treatment of patients who have depression or patients who have suffered, or are at risk of, stroke.
  • SSRls serotonin reuptake inhibitors
  • SNRls selective serotonin/norepinephrine reuptake inhibitors
  • any compositions of the disclosure will vary depending on the symptoms, age and body weight of the patient, the nature and severity of the disorder to be treated or prevented, the route of administration, and the form of the subject composition. Any of the subject formulations may be administered in a single dose or in divided doses. Dosages for the compositions of the disclosure may be readily determined by techniques known to those of skill in the art or as taught herein. In general, satisfactory results can be obtained when the compound is administered to a human at a daily dosage of, for example, between 0.05 nig and 3000 mg (measured as the solid form), e.g. about 10 mg to about 500 nig, or e.g., about 1 to about 200mg/kg.
  • the effectiveness of any subject composition and method of treatment or prevention may be assessed by administering the composition and assessing the effect of the administration by measuring one or more applicable indices, and comparing the post-treatment values of these indices to the values of the same indices prior to treatment.
  • Treatment may be initiated with smaller dosages which are less than the optimum dose of the compound. Thereafter, the dosage may be increased by small increments until the optimum therapeutic effect is attained.
  • compositions may be prepared by conventional means, and, if desired, the compositions may be mixed with any conventional additive, such as an exeipient, a binder, a disintegrating agent, a lubricant, a corrigent, a solubilizing agent, a suspension aid, an emulsifying agent or a coating agent.
  • any conventional additive such as an exeipient, a binder, a disintegrating agent, a lubricant, a corrigent, a solubilizing agent, a suspension aid, an emulsifying agent or a coating agent.
  • wetting agents such as sodium lauryl sulfate and magnesium stearate, as well as coloring agents, release agents, coating agents, sweetening, flavoring and perfuming agents, preservatives and antioxidants may be present in the formulated agents.
  • Suspensions in addition to the subject composition, may contain suspending agents as, for example, ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, macrocrystalline cellulose, aluminum metahydroxide, bentonite, agar-agar and tragacanth, and mixtures thereof,
  • suspending agents as, for example, ethoxylated isostearyl alcohols, polyoxyethylene sorbitol and sorbitan esters, macrocrystalline cellulose, aluminum metahydroxide, bentonite, agar-agar and tragacanth, and mixtures thereof,
  • Exemplary drags that may be used in combination with a GLYX peptide include Anafranil, Adapin, Aventyl, Elavil, Norpramin, Pamelor, Pertofrane, Sinequan, Surmontil, Tofranil, Vivactil, Parnate, Nardil, Marplan, Celexa, Lexapro, Luvox, Paxil, Prozac, Zoloft, Welibutrin, Effexor, Remeron, Cymbalta, Desyrel (trazodone), and Ludiomiil.
  • GLYX-13 was bath- applied at 1, 10, or 50 ⁇ to hippocampal slices for 30 niin prior to brief ejection of high [K+] (1 fflM in patch pipette) into stratum radiatum of the C Al region and attempted to ehcit SD.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Dans certains modes de réalisation, l'invention concerne des procédés pour traiter la migraine (par exemple la migraine épisodique, la migraine chronique, la migraine d'origine rétinienne, la migraine ophtalmologique, la migraine acéphalgique, le trouble migraineux, la migraine menstruelle, la migraine abdominale, les syndromes périodiques de l'enfant ou la céphalée vasculaire de Horton) par l'administration d'un agoniste partiel de NMDAR peptidique. Dans certains modes de réalisation, l'invention concerne également des procédés de traitement ou d'amélioration à long terme des séquelles postmigraine chez un patient par l'administration d'un agoniste partiel de NMDAR peptidique. Dans certains autres modes de réalisation, l'invention concerne des procédés pour traiter, supprimer, ou prévenir la dépression corticale envahissante ou une maladie ou une affection provoquée par une dépression corticale envahissante chez un patient en ayant besoin, comprenant l'administration d'un agoniste partiel de NMDAR peptidique. Par exemple, la présente invention concerne des procédés de traitement de l'épilepsie, d'une lésion cérébrale traumatique, et/ou d'un accident cérébrovasculaire.
PCT/US2015/037177 2014-06-23 2015-06-23 Procédés de traitement ou de soulagement de la migraine Ceased WO2015200322A1 (fr)

Priority Applications (9)

Application Number Priority Date Filing Date Title
CA2953170A CA2953170A1 (fr) 2014-06-23 2015-06-23 Procedes de traitement ou de soulagement de la migraine
AU2015280108A AU2015280108B2 (en) 2014-06-23 2015-06-23 Methods of treating or ameliorating migraine
CN201580033913.6A CN106661085A (zh) 2014-06-23 2015-06-23 治疗或改善偏头痛的方法
BR112016030375A BR112016030375A8 (pt) 2014-06-23 2015-06-23 uso de um composto no tratamento ou melhora da enxaqueca, no tratamento, supressão e/ou prevenção da depressão cortical e no tratamento ou melhora de uma lesão cerebral traumática
KR1020177001848A KR20170018072A (ko) 2014-06-23 2015-06-23 편두통을 치료 또는 경감시키는 방법
EP15811633.5A EP3157943A4 (fr) 2014-06-23 2015-06-23 Procédés de traitement ou de soulagement de la migraine
JP2016575106A JP6688748B2 (ja) 2014-06-23 2015-06-23 片頭痛の治療または改善方法
RU2017101410A RU2721401C2 (ru) 2014-06-23 2015-06-23 Способы лечения или облегчения мигрени
MX2016017388A MX2016017388A (es) 2014-06-23 2015-06-23 Metodos para tratar o aliviar la migraña.

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201462015727P 2014-06-23 2014-06-23
US62/015,727 2014-06-23
US201562109386P 2015-01-29 2015-01-29
US62/109,386 2015-01-29

Publications (1)

Publication Number Publication Date
WO2015200322A1 true WO2015200322A1 (fr) 2015-12-30

Family

ID=54938737

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/037177 Ceased WO2015200322A1 (fr) 2014-06-23 2015-06-23 Procédés de traitement ou de soulagement de la migraine

Country Status (10)

Country Link
EP (1) EP3157943A4 (fr)
JP (2) JP6688748B2 (fr)
KR (1) KR20170018072A (fr)
CN (1) CN106661085A (fr)
AU (1) AU2015280108B2 (fr)
BR (1) BR112016030375A8 (fr)
CA (1) CA2953170A1 (fr)
MX (1) MX2016017388A (fr)
RU (1) RU2721401C2 (fr)
WO (1) WO2015200322A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2972282T3 (es) * 2019-04-15 2024-06-12 Vistagen Therapeutics Inc Tratamiento de la migraña

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040053835A1 (en) * 2000-11-17 2004-03-18 Sophia Kossida Regulation of human nmda receptor
US20120295852A1 (en) * 2009-10-05 2012-11-22 Joseph Moskal Methods of treating depression and other related diseases
US20130053325A1 (en) * 2010-02-11 2013-02-28 Joseph Moskal Secondary Structure Stabilized NMDA Receptor Modulators and Uses Thereof

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995006468A1 (fr) * 1993-09-01 1995-03-09 Smithkline Beecham Corporation Procede de traitement de la migraine
AU2001286763C1 (en) * 2000-08-25 2006-03-02 Research Corporation Technologies, Inc. New uses for amino acid anticonvulsants for treatment of pain
AU2004216904B2 (en) * 2003-03-06 2009-12-24 Botulinum Toxin Research Associates, Inc. Treatment of sinusitis related chronic facial pain and headache with botulinum toxin
WO2010010908A1 (fr) * 2008-07-23 2010-01-28 協和発酵キリン株式会社 Agent thérapeutique antimigraineux
WO2011003064A2 (fr) * 2009-07-02 2011-01-06 Naurex, Inc. Procédés de traitement d'une douleur neuropathique
HRP20140784T1 (hr) * 2009-10-05 2014-10-10 Northwestern University Glyx-13 za uporabu u postupku tretiranja refraktornih depresija
BR112013027554A2 (pt) * 2011-04-27 2016-09-06 Univ Northwestern "usos de compostos no tratamento de mal de alzheimer, doença de huntington, autismo e outros distúrbios"
EP2906722A4 (fr) * 2012-10-12 2016-07-20 Univ Northwestern Procédés d'identification de composés pour traiter la dépression et d'autres maladies associées

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040053835A1 (en) * 2000-11-17 2004-03-18 Sophia Kossida Regulation of human nmda receptor
US20120295852A1 (en) * 2009-10-05 2012-11-22 Joseph Moskal Methods of treating depression and other related diseases
US20130053325A1 (en) * 2010-02-11 2013-02-28 Joseph Moskal Secondary Structure Stabilized NMDA Receptor Modulators and Uses Thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
See also references of EP3157943A4 *
WANG ET AL.: "Effects of NMDA receptor antagonists with different subtype selectivities on retinal spreading depression", BRITISH JOURNAL OF PHARMACOLOGY, vol. 165, 2012, pages 235 - 244, XP055375646 *

Also Published As

Publication number Publication date
EP3157943A1 (fr) 2017-04-26
JP6688748B2 (ja) 2020-04-28
CA2953170A1 (fr) 2015-12-30
CN106661085A (zh) 2017-05-10
BR112016030375A2 (pt) 2017-08-15
RU2017101410A (ru) 2018-07-24
AU2015280108B2 (en) 2019-11-28
MX2016017388A (es) 2018-02-19
EP3157943A4 (fr) 2018-01-24
KR20170018072A (ko) 2017-02-15
BR112016030375A8 (pt) 2021-07-13
JP2020114863A (ja) 2020-07-30
RU2721401C2 (ru) 2020-05-19
RU2017101410A3 (fr) 2019-01-21
JP2017519778A (ja) 2017-07-20
AU2015280108A1 (en) 2017-01-19

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