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Treatment of restless leg syndrome and sleep disorders

A syndrome and restless technology, applied in the direction of drug combinations, active ingredients of heterocyclic compounds, biochemical equipment and methods, etc., can solve problems such as dependence, opiate and anticonvulsant absence, GI disorders, etc.

Inactive Publication Date: 2012-03-28
生物链接治疗股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Benzodiazepine Opiates and anticonvulsants are not as consistently effective as dopaminers and have adverse side effects including tolerance, dependence, and GI dysregulation

Method used

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  • Treatment of restless leg syndrome and sleep disorders
  • Treatment of restless leg syndrome and sleep disorders
  • Treatment of restless leg syndrome and sleep disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0113] Research design

[0114] The study was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study using two treatment arms, oral HPPD inhibitor (2-(2-nitro-4-trifluoromethylbenzoyl)-1, 3-cyclohexanedione) and placebo. Patients were randomly assigned in a 2:1 ratio to treatment with HPPD inhibitors or placebo. Patients were dosed with 4 mg on day 1 and 2 mg / day on days 2-14. For each patient, the total duration of treatment with study drug was 14 consecutive days, ending on the day of the last sleep laboratory measurement (Day 14), with follow-up testing 29 days after baseline.

[0115] The purpose of this exploratory study was to show proof of concept for treatment with an exemplary HPPD inhibitor in patients with moderate to severe congenital RLS. It was determined whether it was possible to demonstrate a reduction in motor symptoms and subjective severity of RLS under 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione treatment compare...

Embodiment 2

[0145] Improvement of sleep parameters

[0146] RLS patients received either placebo (7 patients) or an HPPD inhibitor (13 patients) at 4 mg on day 1, then 2 mg per day on days 2-14 of the trial. During treatment, various parameters related to RLS, especially the quality of sleep patterns, were monitored using a standard measurement scale (Medical Outcomes Study (MOS) Sleep Scale). Subjects were asked to complete a standard assessment of "normal" sleep experience again at the beginning of the trial (Baseline) and at the end of treatment (EoT), using various parameters scored according to the attached document. A trend towards a positive effect was seen in all parameters measured, reaching statistical significance for the parameter "sleep adequacy".

[0147] MOS sleep level

[0148] The MOS sleep scale is a comprehensive patient-completed sleep questionnaire consisting of 12 items (Hays and Stewart, 1992; Hays et al, 2005). Each item measures a unique aspect or characteristi...

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Abstract

Methods of preventing and / or treating at least one symptom of Restless Leg Syndrome (RLS) and its related disorders, including disorders such as periodic limb movements in sleep (PLMS) and periodic limb movement disorder (PLMD), are disclosed. The methods comprise identifying a host, afflicted with Restless Leg Syndrome (RLS) and its related disorders; and administering to the host a pharmaceutically effective amount of a 4-hydroxyphenylpyruvate dioxygenase. Also provided are methods and compositions for treating / preventing sleep disorders, and methods and compositions for improving sleep quantity and adequacy.

Description

field of invention [0001] The present invention relates to novel methods for treating or preventing restless legs syndrome (RLS) and related disorders, and the occurrence of unwanted limb movements. In an exemplary embodiment, the invention relates to the use of an inhibitor of 4-hydroxyphenylpyruvate dioxygenase (HPPD), and in an exemplary embodiment, to 2-(2-nitro-4 - Use of trifluoromethylbenzoyl)-1,3-cyclohexanedione for the treatment or prevention of RLS and / or related disorders. In exemplary embodiments, the present invention also provides methods and compositions for treating or preventing sleep disorders, improving sleep quality and sleep adequacy by administering an HPPD inhibitor to a patient. Background of the invention [0002] Restless legs syndrome (RLS) is a sensorimotor disorder in which individuals with RLS have an unpleasant sensation when the legs are at rest (or during periods of inactivity), causing what is often described as an overwhelming need to mov...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H21/04C12N9/00
CPCA61K31/485A61K31/198A61K31/197C12N9/0069A61K31/00A61K31/122A61K31/48A61K31/55A61P25/00A61P25/02A61P25/16A61P25/20A61P43/00A61K2300/00
Inventor L·皮克福德U·麦雅M·莫兰
Owner 生物链接治疗股份有限公司
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