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Methods and compositions for reduction of side effects of therapeutic treatments

a technology of therapeutic treatment and side effects, applied in the direction of drug compositions, biocide, heterocyclic compound active ingredients, etc., can solve the problems of unsatisfactory side effects, motor abnormalities, affecting the majority of patients, etc., and achieve the effect of reducing or eliminating side effects of dopaminergic agents

Inactive Publication Date: 2010-02-04
THE PARKINSONS INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The patent describes methods, compositions, and kits for using a nicotinic receptor modulator to reduce or eliminate side effects caused by a dopaminergic agent. The nicotinic receptor modulator can be administered to an animal to decrease the likelihood of addiction to the nicotinic receptor modulator when used in combination with a dopaminergic agent. The methods, compositions, and kits can be used to treat side effects such as tremors, headaches, changes in motor function, changes in mental status, changes in sensory functions, seizures, insomnia, paresthesia, dizziness, coma, and dyskinesias. The use of the nicotinic receptor modulator can increase the therapeutic effect of the dopaminergic agent and decrease the likelihood of side effects."

Problems solved by technology

Many of the leading treatments for diseases lead to undesired side effects.
These motor abnormalities may occur after only a few months of treatment and affect the majority of patients within 5-10 years.
They can be quite incapacitating and represent a major complication in Parkinson's disease management.
Currently there are only limited therapeutic options for dyskinesias.

Method used

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  • Methods and compositions for reduction of side effects of therapeutic treatments
  • Methods and compositions for reduction of side effects of therapeutic treatments
  • Methods and compositions for reduction of side effects of therapeutic treatments

Examples

Experimental program
Comparison scheme
Effect test

example 1

Nicotine Reduced Levodopa-Induced Dyskinesias in Monkeys with Nigrostriatal Damage

Materials and Methods

[0242]Animals: Squirrel (Saimiri sciureus) monkeys (n=7) were purchased from World Wide Primates (Miami, Fla.). The animals weighed between 0.6-0.9 kg and were in mid to late adulthood as determined from their general appearance (dentition, fur, other). Female monkeys were used since older animals were available that may better model Parkinson's disease. The animals were placed in quarantine upon arrival, and maintained in a temperature-controlled room (27±3° C.) with a relative humidity>30%, under a 13 / 11-hour light / dark cycle. Monkey food chow and fruits / vegetables were provided once daily, with water provided ad libitum. The monkeys were housed in separate cages to allow for clear behavioral assessments. The animals were released from quarantine after 1 month and treatments initiated. All procedures conformed to the National Institutes of Health Guide for the Care and Use of Lab...

example 2

Nicotine Reduced Dyskinesias in Levodopa-Primed Monkeys

Materials and Methods

[0253]Materials and methods were the same as in example 1.

Results

[0254]Crossover study: The data depicted in FIG. 2-4 and Table 1 clearly showed that nicotine administration attenuated levodopa-induced dyskinesias. A crossover study, was then conducted, in which the animals originally receiving nicotine were given vehicle (n=3), while the vehicle-treated animals were now administered nicotine (n=4). Levodopa treatment was stopped. The concentration of nicotine was gradually increased in the drinking water (see FIG. 1) to 650 μg / ml, at which the animals were maintained for 4 weeks. Monkeys that had previously received nicotine were placed on vehicle drinking water for the same time period. All monkeys were then treated with levodopa (5 mg / kg, twice daily 3.5 hours apart) for a subsequent 8-week period. Since both groups of monkeys had previously received levodopa, they were termed levodopa-primed.

[0255]Nicoti...

example 3

Effect of continuous Delivery of Nicotine on its Antidyskinetic Effect

[0260]Animals: Two groups of experimental animals (see Table 3) are required for these experiments to determine the effectiveness of minipump administration in reducing dyskinesias in lesioned monkeys

TABLE 3Groups for experiments in example 3L-dopa treatmentGroupsnNicotine(5 mg / kg orally)(1) MPTP-lesioned8NoYes(2) MPTP-lesioned8YesYes

[0261]MPTP treatment. All animals are lesioned with an injection of MPTP (1.5-2.0 mg / kg, sc). The animals are rated for parkinsonism 3-4 weeks after lesioning according to methods described in example 1. If an animal is not parkinsonian, MPTP injection will be repeated up to 4 times. The lesioning process may therefore require up to 4 months to generate animals with parkinsonism. Eight animals are required per group as our objective is to obtain stably parkinsonian animals. In general 80% of the animals develop stable parkinsonism. The animals are then allowed to recover from the last...

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PUM

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Abstract

The invention provides compositions and methods utilizing a nicotinic receptor modulator, e.g., to reduce or eliminate a side effect associated with dopaminergic agent treatment. In some embodiments, the invention provides compositions and methods utilizing a combination of a dopaminergic agent and a nicotinic receptor modulator that reduces or eliminates a side effect associated with dopaminergic agent treatment.

Description

CROSS REFERENCE[0001]This application claims the benefit of provisional application 60 / 909,637 entitled Methods and Compositions for Reduction of Side Effects of Therapeutic Treatments filed Apr. 2, 2007; provisional application 60 / 956,296 entitled Methods and Compositions for Reduction of Side Effects of Therapeutic Treatments filed Aug. 16, 2007; and provisional application 60 / 956,657 entitled Methods and Compositions for Reduction of Side Effects of Therapeutic Treatments filed Aug 17, 2007.GOVERNMENT INTERESTS[0002]Certain embodiments of the present invention were made under research grant numbers NIH NS34886 and NS 42091 from the National Institute of Health, who may have certain rights thereto.BACKGROUND OF THE INVENTION[0003]Many of the leading treatments for diseases lead to undesired side effects. For instance, levodopa, the standard for Parkinson's disease treatment, is associated with debilitating abnormal involuntary movements or dyskinesias. These motor abnormalities ma...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/465A61P25/16
CPCA61K31/198A61K31/465A61K45/06A61K2300/00A61P25/14A61P25/16A61P25/28A61P43/00A61K31/197A61K31/5513A61K31/353A61K9/0053
Inventor QUIK, MARYKADI MONTE, DONATOLANGSTON, J. WILLIAM
Owner THE PARKINSONS INST
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