Method for treatment of movement disorders

A technology for dyskinesia and dystonia, applied in the direction of anhydride/acid/halide active ingredients, nervous system diseases, neuromuscular system diseases, etc., which can solve problems such as rebound, gastroesophageal erosion, and increased risk of liver toxicity.

Inactive Publication Date: 2008-01-02
THE TRUSTEES OF COLUMBIA UNIV IN THE CITY OF NEW YORK
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Other disadvantages of treatment with alcohol include gastroesophageal erosions with long-term use, increased risk of hepatotoxicity, including the possibility of cirrhosis, caloric and sugar intake (which may be contraindicated in obese and diabetic patients), and Health Concerns Among Heart Patients
Finally, continued use of alcohol to treat dyskinesias may lead to a rebound effect, in which dyskinesia symptoms return to a more severe condition when the alcohol is tapered off

Method used

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  • Method for treatment of movement disorders
  • Method for treatment of movement disorders
  • Method for treatment of movement disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Xyrem  A single-patient clinical trial for myoclonus after severe hypoxia. The patient was a 37-year-old woman who suffered an accidental anesthesia. After remaining in a coma, she woke up and recovered gradually, however, she was completely disabled due to severe myoclonic spasms that affected her voice, head, proximal arms , legs and torso. On clinical examination, she had positive myoclonus (active spasm) and negative myoclonus (postural deviation). Her myoclonus had been treated with phenobarbital, zonisamide, clonazepam, and levetiracetam without significant improvement. Before the trial, she was treated with clonazepam and levetiracetam. She is allergic to penicillin, has no other known drug allergies, and is otherwise in good general health.

[0077] Case Reports

[0078] Open-label GHB in a single patient with severe debilitating alcohol-responsive posthypoxic myoclonus that is refractory to treatment with standard antimyoclonus agents , Blind grading ...

Embodiment 2

[0097] In this prophetic example, approximately 20 patients will undergo a short-term double-blind, placebo-controlled regimen followed by an open-label extension. The protocol will require dose adjustments of up to 6.125 gm / day during the double-blind period and up to 9 gm / day of options during the open-label period.

[0098] experimental design

[0099] This study is a double-blind, randomized, placebo-controlled, parallel-group, dose-variation trial of dystonic GHB. The study population included patients with clinically apparent myoclonus-dystonia.

[0100] The primary goals include: 1) assessing the safety and tolerability of GHB in dystonic patients, and 2) assessing the efficacy of GHB in the treatment of dystonia. Secondary objectives were: 1) To assess the effect of GHB dose on dystonia.

[0101] The duration of the double-blind portion of the study was 8 weeks. The duration of the fixed-dose portion of the study was 8 weeks. The duration of the dose change port...

Embodiment 3

[0110] patients and methods

[0111] Five patients participated in the trial in the Movement Disorders Division of Columbia University Medical Center in the fall of 2004. All patients had hyperkinetic dyskinesia (defined as a marked change in the patient) responsive to ethanol, and all were refractory to treatment with conventional drugs or could not tolerate them. The Medical Center's Institutional Review Board approved the trial, and written and oral informed consent was obtained from all patients prior to participation in the trial. Prominent clinical features appear below and are summarized in Table 1.

[0112] Table 1: Clinical characteristics of patients with alcohol-responsive dyskinesia

[0113]

Pt #

M / F

age

Dx

t(year)

Current Rx

Past Rx

1

F

37

PHM

6

Levetiracetam 2,5...

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Abstract

The invention is directed to methods of treating movement disorders by administering an effective amount of the compound of formula (I) to patients in need thereof. More particularly, the invention is directed to a method for treating myoclonus including administering to a patient a compound of formula (I), wherein the myoclonus is not alcohol responsive essential myoclonus with dystonia. In some embodiments, the myoclonus is posthypoxic myoclonus. The invention is also directed to a method for treating dystonia, essential tremor cerebellar tremor, a tic, or chorea, including administering to a patient a compound of formula (I).

Description

[0001] This application claims priority to US Provisional Patent Application Serial No. 60 / 626,645, filed on November 10, 2004, which is incorporated herein by reference in its entirety. [0002] All patents, patent applications and publications cited herein are incorporated by reference in their entirety. The disclosures of these publications in their entireties are hereby incorporated by reference into this application in order to more fully describe the state of the art known to those skilled in the art prior to the filing date of the invention described herein. [0003] This patent disclosure contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the US Patent and Trademark Office patent file or docket, but reserves any and all copyrights. [0004] The present invention relates to movement disorders such as hyperkinetic movement d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/47
CPCA61K31/19A61P21/00A61P21/02A61P25/08A61P25/14A61K31/47
Inventor S·弗鲁奇特
Owner THE TRUSTEES OF COLUMBIA UNIV IN THE CITY OF NEW YORK
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