EP1940398A1 - Utilisation de pramipexol pour traiter le syndrome des jambes sans repos (rls) modere a severe - Google Patents

Utilisation de pramipexol pour traiter le syndrome des jambes sans repos (rls) modere a severe

Info

Publication number
EP1940398A1
EP1940398A1 EP06807270A EP06807270A EP1940398A1 EP 1940398 A1 EP1940398 A1 EP 1940398A1 EP 06807270 A EP06807270 A EP 06807270A EP 06807270 A EP06807270 A EP 06807270A EP 1940398 A1 EP1940398 A1 EP 1940398A1
Authority
EP
European Patent Office
Prior art keywords
rls
severe
moderate
use according
active ingredient
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Withdrawn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
EP06807270A
Other languages
German (de)
English (en)
Inventor
Juergen Reess
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 International GmbH
Boehringer Ingelheim Pharma GmbH and Co KG
Original Assignee
Boehringer Ingelheim International GmbH
Boehringer Ingelheim Pharma GmbH and Co KG
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 International GmbH, Boehringer Ingelheim Pharma GmbH and Co KG filed Critical Boehringer Ingelheim International GmbH
Publication of EP1940398A1 publication Critical patent/EP1940398A1/fr
Withdrawn legal-status Critical Current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
    • 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
    • A61P25/14—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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs

Definitions

  • the invention relates to the use of 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzo-thiazole, its (+) - or (-) - enantiomer or its pharmacologically acceptable salts for the treatment of moderate to severe Restless Legs Syndrome (RLS).
  • RLS Restless Legs Syndrome
  • Pramipexole - the 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzo-thiazole dihydrochloride - is a dopamine D2 / D3 agonist whose synthesis is described in European Patent 186,087.
  • Pramipexole is primarily for the treatment of idiopathic Parkinson's, known as monotherapy or in combination with levodopa. From German patent application DE 38 43 227 it is known that pramipexole lowers the prolactin serum level, furthermore it is known from German patent application DE 39 33 738 to use pramipexole to lower high TSH levels.
  • Restless Legs Syndrome (synonyms: RLS, Anxietas tibiarum, Restless Legs Syndrome, Wittmaack-Ekbom Syndrome) is a neurological disorder characterized by an uncontrolled urge to move the legs. Usually, unpleasant and sometimes painful sensations in the legs, such as tingling, pulling, tearing, itching, burning, cramps, etc. are accompanying symptoms of the disease. RLS is estimated to affect up to ten percent of those aged 30 to 79 years old. The symptoms worsen towards evening and at night, so that those affected often additionally suffer from sleep disorders. The consequences are fatigue and irritability during the day with the corresponding consequences for daily work and the shaping of social life.
  • L-DOPA levodopa
  • the term improvements in the symptoms of RLS is understood to mean that pramipexole increases the score on the RLSRS scale after 3 weeks of treatment by at least 10 points, preferably by at least 12 points, more preferably by at least 14, and even more preferably by can reduce at least 15 points and this value continues beyond that.
  • pramipexole in single doses in the form of tablets containing 0.1 to 1.5 mg, preferably 0.1 to 1 mg, more preferably 0.125 mg, to 0.75 mg of active ingredient taken once a day, extremely efficient and well tolerated. With continuous administration of pramipexole Remains the symptom improvement in RLS patients for at least 6 months or more (sustained effect).
  • Preferred daily dosages are between 0.08 and 1 mg.
  • the following daily dosages and all intermediate values are: 0.088 mg, 0.18 mg, 0.125 mg, 0.25 mg; 0.35 mg, 0.5 mg; 0.7 mg, 0.75 mg.
  • Pramipexole is preferably added as free base, 2-amino-6-n-propylamino-4, 5,6,7-tetrahydrobenzothiazoline or in the form of a pharmacologically acceptable salt. Particular preference is given to salts with hydrochloric acid, in particular the dihydrochloride.
  • the severity of RLS symptoms increased significantly more significantly over the study period in the placebo group than in the pramipexole group.
  • the adjusted mean deviation (SE) from the baseline according to the international RLS scale was +14.86 for the placebo group and +2.03 for the pramipexole group.
  • SE mean deviation

Landscapes

  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Psychology (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Thiazole And Isothizaole Compounds (AREA)

Abstract

La présente invention concerne l'utilisation de 2-amino-6-n-propylamino-4,5,6,7-tétrahydrobenzo-thiazol, de ses énantiomères (+) ou (-) ou de sels de celui-ci, pharmacologiquement compatibles, pour traiter le syndrome des jambes sans repos (RLS) modéré à sévère.
EP06807270A 2005-10-18 2006-10-16 Utilisation de pramipexol pour traiter le syndrome des jambes sans repos (rls) modere a severe Withdrawn EP1940398A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US72798505P 2005-10-18 2005-10-18
PCT/EP2006/067408 WO2007045620A1 (fr) 2005-10-18 2006-10-16 Utilisation de pramipexol pour traiter le syndrome des jambes sans repos (rls) modere a severe

Publications (1)

Publication Number Publication Date
EP1940398A1 true EP1940398A1 (fr) 2008-07-09

Family

ID=37671401

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06807270A Withdrawn EP1940398A1 (fr) 2005-10-18 2006-10-16 Utilisation de pramipexol pour traiter le syndrome des jambes sans repos (rls) modere a severe

Country Status (5)

Country Link
US (1) US20080262053A1 (fr)
EP (1) EP1940398A1 (fr)
JP (1) JP2009511618A (fr)
CA (1) CA2626249A1 (fr)
WO (1) WO2007045620A1 (fr)

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EP2308464A1 (fr) 2009-10-06 2011-04-13 Sanovel Ilac Sanayi ve Ticaret A.S. Compositions orales désintégrables de pramipexole

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US9468630B2 (en) 2013-07-12 2016-10-18 Knopp Biosciences Llc Compositions and methods for treating conditions related to increased eosinophils
CN105764507B (zh) 2013-07-12 2019-07-19 诺普生物科学有限责任公司 治疗升高的嗜酸性粒细胞和/或嗜碱性粒细胞的水平
ES2871556T3 (es) 2013-08-13 2021-10-29 Knopp Biosciences Llc Composiciones y métodos para el tratamiento de la urticaria crónica
ES2813674T3 (es) 2013-08-13 2021-03-24 Knopp Biosciences Llc Composiciones y métodos para el tratamiento de trastornos de células plasmáticas y trastornos prolinfocíticos de células b
US9096537B1 (en) 2014-12-31 2015-08-04 Mahesh Kandula Compositions and methods for the treatment of mucositis
WO2016110865A1 (fr) 2015-01-06 2016-07-14 Cellix Bio Private Limited Compositions et méthodes pour le traitement d'une inflammation et de la douleur
WO2016046835A1 (fr) 2014-09-26 2016-03-31 Cellix Bio Private Limited Compositions et méthodes de traitement de l'épilepsie et de troubles neurologiques
CN107207403A (zh) 2014-09-29 2017-09-26 塞尔利克斯生物私人有限公司 用于治疗多发性硬化的组合物和方法
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US9284287B1 (en) 2014-11-05 2016-03-15 Cellix Bio Private Limited Compositions and methods for the suppression of carbonic anhydrase activity
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Cited By (1)

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Publication number Priority date Publication date Assignee Title
EP2308464A1 (fr) 2009-10-06 2011-04-13 Sanovel Ilac Sanayi ve Ticaret A.S. Compositions orales désintégrables de pramipexole

Also Published As

Publication number Publication date
CA2626249A1 (fr) 2007-04-26
US20080262053A1 (en) 2008-10-23
JP2009511618A (ja) 2009-03-19
WO2007045620A1 (fr) 2007-04-26

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