WO2007045620A1 - Verwendung von pramipexol zur behandlung des moderaten bis schweren restless legs syndroms (rls) - Google Patents
Verwendung von pramipexol zur behandlung des moderaten bis schweren restless legs syndroms (rls) Download PDFInfo
- Publication number
- WO2007045620A1 WO2007045620A1 PCT/EP2006/067408 EP2006067408W WO2007045620A1 WO 2007045620 A1 WO2007045620 A1 WO 2007045620A1 EP 2006067408 W EP2006067408 W EP 2006067408W WO 2007045620 A1 WO2007045620 A1 WO 2007045620A1
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- WIPO (PCT)
- Prior art keywords
- rls
- severe
- moderate
- use according
- active ingredient
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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
- 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
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- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Neurosurgery (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Psychology (AREA)
- Epidemiology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Thiazole And Isothizaole Compounds (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/090,428 US20080262053A1 (en) | 2005-10-18 | 2006-10-16 | Use of Pramipexole for Treating Moderate to Severe Restless Legs Syndrome (Rls) |
EP06807270A EP1940398A1 (de) | 2005-10-18 | 2006-10-16 | Verwendung von pramipexol zur behandlung des moderaten bis schweren restless legs syndroms (rls) |
JP2008536031A JP2009511618A (ja) | 2005-10-18 | 2006-10-16 | 中度から重度のむずむず脚症候群(rls)を治療するためのプラミペキソールの使用 |
CA002626249A CA2626249A1 (en) | 2005-10-18 | 2006-10-16 | Use of pramipexol for treating moderate to severe restless legs syndrome (rls) |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US72798505P | 2005-10-18 | 2005-10-18 | |
US60/727,985 | 2005-10-18 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2007045620A1 true WO2007045620A1 (de) | 2007-04-26 |
Family
ID=37671401
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2006/067408 WO2007045620A1 (de) | 2005-10-18 | 2006-10-16 | Verwendung von pramipexol zur behandlung des moderaten bis schweren restless legs syndroms (rls) |
Country Status (5)
Country | Link |
---|---|
US (1) | US20080262053A1 (de) |
EP (1) | EP1940398A1 (de) |
JP (1) | JP2009511618A (de) |
CA (1) | CA2626249A1 (de) |
WO (1) | WO2007045620A1 (de) |
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WO2008145252A1 (en) * | 2007-05-25 | 2008-12-04 | Boehringer Ingelheim International Gmbh | Pharmaceutical formulation comprising pramipexole |
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US9512096B2 (en) | 2011-12-22 | 2016-12-06 | Knopp Biosciences, LLP | Synthesis of amine substituted 4,5,6,7-tetrahydrobenzothiazole compounds |
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US10179774B2 (en) | 2007-03-14 | 2019-01-15 | Knopp Biosciences Llc | Synthesis of chirally purified substituted benzothiazole diamines |
US10383857B2 (en) | 2013-07-12 | 2019-08-20 | Knopp Biosciences Llc | Compositions and methods for treating conditions related to elevated levels of eosinophils and/or basophils |
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Citations (2)
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WO1998031362A1 (en) * | 1997-01-17 | 1998-07-23 | Pharmacia & Upjohn Company | Use of pramipexole in the treatment of restless legs syndrome |
WO2003049705A2 (en) * | 2001-12-11 | 2003-06-19 | University Of Virginia Patent Foundation | Use of pramipexole to treat amyotrophic lateral sclerosis |
Family Cites Families (5)
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DE3572485D1 (en) * | 1984-12-22 | 1989-09-28 | Thomae Gmbh Dr K | Tetrahydro-benzothiazoles, their production and their use as intermediates or drugs |
DE3937271A1 (de) * | 1989-11-09 | 1991-05-16 | Boehringer Ingelheim Kg | Transdermale applikation von 2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazol |
DE4241013A1 (de) * | 1992-12-05 | 1994-06-09 | Boehringer Ingelheim Kg | Verwendung von 2-Amino-6-n-propyl-amino-4,5,6,7-tetrahydrobenzothiazol als Arzneimittel mit antidepressiver Wirkung |
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-
2006
- 2006-10-16 EP EP06807270A patent/EP1940398A1/de not_active Withdrawn
- 2006-10-16 WO PCT/EP2006/067408 patent/WO2007045620A1/de active Application Filing
- 2006-10-16 JP JP2008536031A patent/JP2009511618A/ja active Pending
- 2006-10-16 US US12/090,428 patent/US20080262053A1/en not_active Abandoned
- 2006-10-16 CA CA002626249A patent/CA2626249A1/en not_active Abandoned
Patent Citations (2)
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WO1998031362A1 (en) * | 1997-01-17 | 1998-07-23 | Pharmacia & Upjohn Company | Use of pramipexole in the treatment of restless legs syndrome |
WO2003049705A2 (en) * | 2001-12-11 | 2003-06-19 | University Of Virginia Patent Foundation | Use of pramipexole to treat amyotrophic lateral sclerosis |
Non-Patent Citations (8)
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Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2008074033A1 (en) * | 2006-12-14 | 2008-06-19 | Knopp Neurosciences, Inc. | Compositions and methods of using (r)-pramipexole |
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JP2010527946A (ja) * | 2007-05-25 | 2010-08-19 | ベーリンガー インゲルハイム インターナショナル ゲゼルシャフト ミット ベシュレンクテル ハフツング | プラミペキソールを含有する医薬製剤 |
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US10456381B2 (en) | 2013-08-13 | 2019-10-29 | Knopp Biosciences Llc | Compositions and methods for treating plasma cell disorders and B-cell prolymphocytic disorders |
US10195183B2 (en) | 2013-08-13 | 2019-02-05 | Knopp Biosciences Llc | Compositions and methods for treating chronic urticaria |
US10028940B2 (en) | 2013-08-13 | 2018-07-24 | Knopp Biosciences Llc | Compositions and methods for treating plasma cell disorders and B-cell prolymphocytic disorders |
US9763918B2 (en) | 2013-08-13 | 2017-09-19 | Knopp Biosciences Llc | Compositions and methods for treating chronic urticaria |
Also Published As
Publication number | Publication date |
---|---|
EP1940398A1 (de) | 2008-07-09 |
US20080262053A1 (en) | 2008-10-23 |
CA2626249A1 (en) | 2007-04-26 |
JP2009511618A (ja) | 2009-03-19 |
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