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Cladribine regimen for treating multiple sclerosis

A multiple sclerosis, the most technology, applied in the direction of pharmaceutical formulations, organic active ingredients, medical preparations containing active ingredients, etc., can solve problems such as insufficient severity

Inactive Publication Date: 2007-12-19
MERCK SERONO SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The side effects observed with the above regimens were reported to be less severe than those observed in studies of intravenous cladribine in patients with chronic progressive multiple sclerosis (Sipe et al., 1994, Lancet, 344, 9-13) , but still appears

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0174] Example 1: Oral Cladribine Treatment of Relapsed Forms of MS

[0175]60 patients with clinically confirmed relapsed forms of multiple sclerosis were studied. First check to make sure that each patient's liver, kidney, and bone marrow functions are normal to establish a baseline value.

[0176] Select male and female patients aged 18-55 who have had one or more relapses in the previous 12 months. Female patients are non-pregnant women.

[0177] The patients were randomly assigned to one of the treatment groups listed in Table 1 below:

[0178] Table 1:

[0179] Group

2-CdA

1

-

2

1.75mg / kg

3

3.5mg / kg

[0180] Each patient in groups 2 and 3 received 3 mg or 10 mg 2-CdA per day (1, 2 or 3 doses, depending on the weight of the patient), combined with the cyclodextrin formulation described in Example 3 of WO2004 / 087101 medicine. Table 2 below lists the components of the Cladribine formulation in 3 mg or 10 mg 2-CdA tablet...

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Abstract

The present invention is related to the use of Cladribine for the preparation of a pharmaceutical formulation for the treatment of multiple sclerosis, especially relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis, wherein the preparation is to be the orally administered and wherein re-treatments are possible.

Description

Invention field [0001] The present invention relates to the use of multiple doses of cladribine to treat multiple sclerosis, especially to relieve relapsing multiple sclerosis or progressive multiple sclerosis after early recurrence. Background of the invention [0002] Multiple sclerosis (MS) is the most common chronic inflammatory demyelinating disease in the central nervous system of the human body. The disease occurs more than 20-40 years, and the incidence of women is about twice that of men. [0003] MS can cause the accumulation of multiple neurological dysfunctions. The clinical dysfunction of MS is considered to be the result of repeated inflammatory injury and subsequent loss of myelin and axon, which leads to tissue atrophy. [0004] MS manifests as physical symptoms (progressive recurrent attacks and dysfunction), central nervous system (CNS) inflammation, brain atrophy and cognitive impairment. The symptoms include: local sensory loss, local weakness, visual disturba...

Claims

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Application Information

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IPC IPC(8): A61K31/7076A61K38/21A61P25/00
Inventor G・德鲁卡
Owner MERCK SERONO SA
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