Method of treating tremors

a tremor and tremor technology, applied in the field of tremor treatment methods, can solve the problems of high risk of complications, low treatment effect, and low safety of patients, and achieve the effect of reducing the symptoms of tremors

Inactive Publication Date: 2008-04-03
EISAI INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Current drug treatments of tremors do not offer long-term sustained efficacy and pose a high risk of complications with prolonged use.
These procedures, which involve stimulation or ablation of the thalamic region via surgical intervention, have a risk factor of aneurysm and death of about 2 to 3%.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Materials and Methods for Evaluating Zonisamide in Rodent Model

[0046] Test Animals Adult Sprague-Dawley female rats (Harlan Sprague Dawley, Inc., CA) at approximately 200-250 grams of body weight are used in this experiment. Animals are allowed free access to water and commercial rodent diet under standard laboratory conditions. The room temperature is maintained at 20-23° C. and illumination is on a 12 / 12-hour light dark cycle.

[0047] Based upon the design of the experiment, a total of sixty animals are used in the experiment (Tables 1, 2).

[0048] Drug Preparation: All solutions are prepared fresh for each day of experimental trial. The dose preparation procedures for the zonisamide are provided by the Sponsor.

[0049] Tremorigenic Agent: Harmaline (Sigma) is the most widely used experimental tremor-inducing agent, and numerous studies have been published using this agent in rodent model. Studies suggest that an olivocerebello-bulbospinal pathway mediates harmaline-induced tremor, ...

example 2

Harmaline-Induced Pilot Study

[0054] A prolonged harmaline tremor is needed in order to clearly see the effect of the zonisamide. Subcutaneous harmaline injections give a prolonged response to drugs in general, and are suitable for the zonisamide study. This pilot study determines an effective dose / delivery of harmaline that produces a prolonged 8-12 Hz tremor, ideally lasting at least three hours. Five animals are given 10 mg / kg i.p., or 10 mg / kg s.c. of harmaline (see Table 1). The successful dose / delivery is determined based on the following criteria: 80% or more of all the test animals, per each harmaline-dosing group, have tremor activity at 8-12 Hz lasting for at least 3 hours.

[0055] All animals are treated as described in Table 1.

TABLE 1Harmaline Pilot StudyGroupHarmaline DoseDose Volume (ml / kg)Number of Animals110mg / kg, i.p.1 ml / kg5210mg / kg, s.c.1 ml / kg5

[0056] Harmaline Pilot Study Protocol: (1) Place rat in tremor cage for 10 min.; (2) Record activity for 20 min. (baseli...

example 3

Effects of Harmaline on Inducing Tremor

[0057] Six female Sprague-Dawley rats were treated with i.p. saline and placed in a tremor monitoring cage for 30 minutes of baseline recording. They then received 10 mg / kg harmaline i.p. to induce tremor. Recording of the harmaline-induced tremor began 15 minutes after the harmaline injection and continued for up to 2½ hours.

[0058] A transducer connected to the cage floor recorded motion, which was processed by Fourier transform and spectral analysis. Motion at 8-12 Hz (the range in which the tremor occurs) was compared to the full spectrum of motion recorded (0-15 Hz). The results show that the effect of harmaline on inducing tremor in rates was stable for over two hours.

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Abstract

The invention is directed to the use of a pharmaceutical composition comprising an effective amount of zonisamide or a pharmaceutically acceptable salt thereof to treat tremors, such as rest tremors or action tremors. Tremors may include kinetic tremor, essential tremor, severe essential tremor, postural tremor, drug-induced tremor, toxic tremor, primary orthostatic tremor, dystonic tremor, neuropathic tremor, and cerebellar tremor. The use of zonisamide in the methods of the invention reduce adverse side effects of other drugs that are used to treat tremors. Zonisamide or a pharmaceutically acceptable salt thereof can also be used in conjunction with other therapeutic agents commonly used to treat tremors, thus enhancing the therapeutic effect of treating tremors.

Description

RELATED APPLICATIONS [0001] This application is a continuation under § 120 of U.S. application Ser. No. 10 / 663,187 filed Sep. 15, 2003, issued as U.S. Pat. No. 7,273,884 on Sep. 25, 2007, which claims priority under § 119 to U.S. Provisional Application No. 60 / 410,399, filed Sep. 13, 2002.FIELD OF THE INVENTION [0002] The present invention relates to methods of treating tremors, particularly essential tremor, with zonisamide (1,2-benzioxazole-3-methanesulfonamide). BACKGROUND OF THE INVENTION [0003] Tremor is defined as an involuntary, rhythmic oscillatory movement of a part or parts of the body, resulting from alternating or irregularly synchronous contractions of antagonist muscles. Tremor is the most common form of involuntary movement. Almost all individuals have experienced tremor at some point in their lives; however, only a small fraction of those with tremor seek medical attention. Tremors may result from normal (physiologic) or pathologic processes and may be characterized ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/42A61K31/425
CPCA61K31/425A61P25/10
Inventor SHELLENBERGER, M. KENT
Owner EISAI INC
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