EP1416930A1 - Pramipexol zur behandlung von adhd - Google Patents

Pramipexol zur behandlung von adhd

Info

Publication number
EP1416930A1
EP1416930A1 EP02762417A EP02762417A EP1416930A1 EP 1416930 A1 EP1416930 A1 EP 1416930A1 EP 02762417 A EP02762417 A EP 02762417A EP 02762417 A EP02762417 A EP 02762417A EP 1416930 A1 EP1416930 A1 EP 1416930A1
Authority
EP
European Patent Office
Prior art keywords
acid
pramipexole
use according
treatment
prevention
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.)
Withdrawn
Application number
EP02762417A
Other languages
German (de)
English (en)
French (fr)
Inventor
Jürgen REESS
Franco Borsini
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.)
Boehringer Ingelheim Pharma GmbH and Co KG
Boehringer Ingelheim Pharmaceuticals Inc
Original Assignee
Boehringer Ingelheim Pharma GmbH and Co KG
Boehringer Ingelheim Pharmaceuticals 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 Boehringer Ingelheim Pharma GmbH and Co KG, Boehringer Ingelheim Pharmaceuticals Inc filed Critical Boehringer Ingelheim Pharma GmbH and Co KG
Publication of EP1416930A1 publication Critical patent/EP1416930A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/428—Thiazoles condensed with carbocyclic rings
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • 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 invention relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, its (+) or (-) enantiomer, its pharmacologically acceptable acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of ADHD.
  • the 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzo-thiazole is a dopamine agonist which is also known in the art as pramipexole.
  • Pramipexole and processes for its production are known for example from EP-A-186 087 and US 4,886,812.
  • the utility of pramipexole for the treatment of schizophrenia and in particular for the treatment of Parkinson's is known.
  • the prior art also discloses, for example, that pramipexole lowers the prolactin serum level (DE 38 43 227).
  • pramipexole can be used in therapeutically effective doses for the prevention and / or treatment of ADHD.
  • the present invention relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, optionally in the form of its (+) or its (-) enantiomer, optionally in the form of the pharmacologically acceptable one Acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of ADHD.
  • ADHD stands for "attention deficit hyperactivity disorder”. It describes a disorder that occurs in both children and adults in the form of an attention deficit. ADHD is also understood to be a hyperactivity disorder that can also be observed in both children and adults. Depending on which of the above-mentioned disorders dominates, ADHD can be observed in different forms. There is the mixed type, in which both a deficit in attention and a hyperactivity disorder can be observed, the predominantly inattentive type and the predominantly hyperactive-impulsive type.
  • the mixed type occurs when at least six out of nine symptoms of attention deficit disorder and hyperactivity / impulsivity persist for at least six months. Have at least six symptoms of Attention deficit, but less than six of the hyperactivity / impulsivity persisted for at least six months is the predominantly inattentive type.
  • the predominantly hyperactive-impulsive type is when at least six symptoms from the area of hyperactivity / impulsivity but less than six from the area of inattentiveness have been present over a period of at least six months.
  • Inattentiveness a) often disregards details or makes careless mistakes in school work, work or other activities; (b) often has difficulty keeping attention on tasks or playing for long periods of time; c) often does not seem to listen when others address him / her; d) often does not fully complete instructions from others and cannot complete schoolwork, other work or duties at the workplace; e) often has difficulty organizing tasks and activities; f) often avoids, dislike, or is reluctant to undertake tasks that require prolonged mental effort; (g) often loses items that he / she needs for tasks or activities; h) can easily be distracted by external stimuli; i) is often forgetful in everyday activities;
  • Hyperactivity a) often fidgets with hands or feet or slips around on the chair; b) stands up frequently in class or in other situations where sitting is expected; c) often runs around or climbs excessively in situations where it is inappropriate (in adolescents or adults this can be limited to a subjective feeling of restlessness); d) often has difficulty playing quietly or engaging in leisure activities; e) is often "on the move” or often acts as if he / she was “driven”; (f) often talks excessively; Impulsiveness;
  • the present invention further relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, optionally in the form of its (+) or its (-) enantiomer, optionally in the form of the pharmacological one compatible acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of attention deficits.
  • the present invention further relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, optionally in the form of its (+) or its (-) enantiomer, optionally in the form of the pharmacologically acceptable one Acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of hyperactivity disorders.
  • Another aspect of the present invention relates to the use of 2-amino-4,5,6,7-tetrahydro-6-n-propylamino-benzothiazole, optionally in the form of its (+) or (-) enantiomer, optionally in the form of the pharmacologically acceptable acid addition salts and hydrates and solvates for the manufacture of a medicament for the prevention and / or treatment of hyperactivity disorders associated with attention deficits.
  • a combination therapy of pramipexole with one or more, preferably another, pharmaceutically active compound can alternatively be carried out.
  • the combination with active substances selected from the group consisting of ⁇ -sympatomimetics and antidepressants, preferably tricyclic antidepressants, antidepressants of the SSRI or MAO type can prove to be effective.
  • pramipexole in a sensible manner for the treatment of the aforementioned conditions, preferably with one or more, preferably one of the following substances: Methylphenidate, amphethamine, amphetaminil, metamphetamine, pemoline, tomoxetine, desipramine, imipramine, bupropion and modafinil, methylphenidate, amphetamine, pemolin, tomoxetine and modafinil being particularly preferred.
  • pramipexole can be used as a racemate, in the form of its (+) - or in the form of its (-) - enantiomer. Pramipexole can also be used in the form of its pharmaceutically acceptable acid addition salts and, if appropriate, in the form of its hydrates and / or solvates.
  • pharmaceutically acceptable acid addition salts are understood to be those salts which are selected from the salts of hydrochloric acid, hydrobromic acid, sulfuric acid, phosphoric acid, methanesulfonic acid, acetic acid, fumaric acid, succinic acid, lactic acid, citric acid, tartaric acid and maleic acid, the salts of hydrochloric acid, hydrobromic acid, sulfuric acid , Phosphoric acid, and acetic acid are particularly preferred.
  • the salts of hydrochloric acid are of particular importance here. Accordingly, the hydrochlorides of pramipexole are particularly preferably used in the context of the present invention, the pramipexole dihydrochloride being of particular importance. Of the hydrates of the pramipexole, the pramipexole dihydrochloride monohydrate is particularly preferred.
  • Pramipexole is naturally very dependent on the clinical picture.
  • pramipexole can be used in doses of about 0.05 to 7.5 mg, preferably 0.1 to 5 mg, per day. These dosages are based on pramipexole in the form of its free base. Based on the preferred salt form pramipexole dihydrochloride monohydrate, the above-mentioned dosages correspond to about 0.07 to 10 t 65 mg, preferably 0.14 to 7.1 mg pramipexole dihydrochloride monohydrate per day.
  • Pramipexole can be administered orally, transdermally, intrathecally, by inhalation or parenterally in the context of the use according to the invention. Suitable forms of use are, for example, tablets, capsules, suppositories, solutions, juices, emulsions, dispersible powders or plasters. With regard to possible embodiments of a transdermal one which can be used according to the invention
  • Corresponding tablets can be mixed, for example, by mixing the active ingredient (s) with known auxiliaries, for example inert diluents such as calcium carbonate, calcium phosphate or milk sugar, and disintegrants
  • the tablets can also consist of several layers.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Epidemiology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Thiazole And Isothizaole Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
EP02762417A 2001-08-03 2002-07-31 Pramipexol zur behandlung von adhd Withdrawn EP1416930A1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10137633A DE10137633A1 (de) 2001-08-03 2001-08-03 Pramipexol zur Behandlung von ADHD
DE10137633 2001-08-03
PCT/EP2002/008500 WO2003013520A1 (de) 2001-08-03 2002-07-31 Pramipexol zur behandlung von adhd

Publications (1)

Publication Number Publication Date
EP1416930A1 true EP1416930A1 (de) 2004-05-12

Family

ID=7693957

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02762417A Withdrawn EP1416930A1 (de) 2001-08-03 2002-07-31 Pramipexol zur behandlung von adhd

Country Status (8)

Country Link
EP (1) EP1416930A1 (https=)
JP (1) JP2005500368A (https=)
AR (1) AR035273A1 (https=)
CA (1) CA2453485A1 (https=)
DE (1) DE10137633A1 (https=)
MX (1) MXPA04001001A (https=)
UY (1) UY27408A1 (https=)
WO (1) WO2003013520A1 (https=)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2295040A1 (en) 2009-09-11 2011-03-16 Sanovel Ilac Sanayi ve Ticaret A.S. Pharmaceutical compositions of pramipexole
EP2308464A1 (en) 2009-10-06 2011-04-13 Sanovel Ilac Sanayi ve Ticaret A.S. Orally disintegrating compositions of pramipexole

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5621133A (en) * 1989-05-31 1997-04-15 Deninno; Michael P. Dopamine agonists
US7049337B2 (en) * 2000-05-19 2006-05-23 Wayne State University Derivatives of 2-aminotetralins and pharmaceutical analogs thereof exhibiting differential CNS receptor activity and behavior
US20020016334A1 (en) * 2000-07-31 2002-02-07 Coe Jotham Wadsworth Pharmaceutical composition for the treatment of attention deficit hyperactivity disorder (ADHD)
US6613308B2 (en) * 2000-09-19 2003-09-02 Advanced Inhalation Research, Inc. Pulmonary delivery in treating disorders of the central nervous system

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
LAGOS P. ET AL: "Effects of the D3 preferring dopamine agonist pramipexole on sleep and waking, locomotor activity and striatal dopamine release in rats", EUROPEAN NEUROPSYCHOPHARMACOLOGY, vol. 8, no. 2, 1 May 1998 (1998-05-01), pages 113 - 120, XP007906317, DOI: doi:10.1016/S0924-977X(97)00054-0 *
See also references of WO03013520A1 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2295040A1 (en) 2009-09-11 2011-03-16 Sanovel Ilac Sanayi ve Ticaret A.S. Pharmaceutical compositions of pramipexole
EP2308464A1 (en) 2009-10-06 2011-04-13 Sanovel Ilac Sanayi ve Ticaret A.S. Orally disintegrating compositions of pramipexole

Also Published As

Publication number Publication date
AR035273A1 (es) 2004-05-05
DE10137633A1 (de) 2003-02-20
CA2453485A1 (en) 2003-02-20
JP2005500368A (ja) 2005-01-06
MXPA04001001A (es) 2004-04-20
WO2003013520A1 (de) 2003-02-20
UY27408A1 (es) 2003-02-28

Similar Documents

Publication Publication Date Title
DE69623141T2 (de) Verwendung von Tomoxetin zur Behandlung von Hyperaktivität mit Aufmerksamkeitsstörungen
DE60026627T2 (de) Reboxetin zur Behandlung von Fibromyalgie und anderen somatoformen Störungen
HUE026484T2 (en) Alpha-aminoamide derivatives useful in the treatment of cognitive disorders
JP7436524B2 (ja) ハンチントン病及びその症状を治療するためのプリドピジン及びその類似体を含む組成物
AU2000255966B2 (en) Treating smooth muscle hyperactivity with (r)-oxybutynin and (r)- desethyloxybutynin
DE60221670T2 (de) Carbamatverbindungen zur vorbeugung und behandlung von bewegungsstörungen
DE60122015T2 (de) Behandlung affektiver störungen durch kombinierte wirkung eines nikotinischen rezeptoragonisten und einer monoaminergischen substanz
DE10148233A1 (de) Verbindungen zur Reduzierung übermäßiger Nahrungsaufnahme
DE69607904T2 (de) Potenzierung von Serotonin-Wirkstoffresponz
EP1928451B1 (en) Methods for treating substance-related disorders
DE60216457T2 (de) Carbamate verbindungen zur behandlung oder verhutung von psychotischen krankheiten
DE69923081T2 (de) Desmethylolanzapine enthaltende zusammensetzungen und verfahren
US20080146628A1 (en) Pramipexole for the treatment of adhd
EP1416930A1 (de) Pramipexol zur behandlung von adhd
DE69907220T2 (de) Verwendung von substanz p antagonisten zur behandlung des chronischen ermüdungssyndroms und/oder der fibromyalgie
CN104623671B (zh) 含有乙酰胆碱酯酶抑制剂和二甲双胍的复方药用组合物
EP1418908B1 (de) Verbindungen zur beseitigung und/oder linderung der anhedonie
DE10312809A1 (de) Pramipexol zur Reduzierung übermäßiger Nahrungsaufnahme bei Kindern
DE60112750T2 (de) Pharmazeutische zusammensetzung enthaltend famotidine für die behandlung von depressionen
EP1414446B1 (de) Pramipexol als antikonvulsivum
CA3084623C (en) The use of 3-(2-(4-(2-methoxyphenyl)piperazin-1-yl)ethyl)quinazolin-4(3h)- one in the treatment of post-traumatic stress disorder
DE3686538T2 (de) Verwendung von dibenz(cd,f)indol-derivaten zur praevention vom alkoholmissbrauch.
WO2003061654A9 (de) Pramipexol zur behandlung von hiv demenz
HK40065904A (en) Composition comprising pridopidine and analog thereof for treating huntington disease and symptoms thereof
HK40065904B (en) Composition comprising pridopidine and analog thereof for treating huntington disease and symptoms thereof

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20040303

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR IE IT LI LU MC NL PT SE SK TR

AX Request for extension of the european patent

Extension state: AL LT LV MK RO SI

17Q First examination report despatched

Effective date: 20071227

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20090421