Efficacy and safety of Miltefosine in antihistamine resistant chronic urticaria - MIARC

• Conditions: rticaria characterized by mast cell and histamine-dependent wheal and flair type-skin responses associated with severe pruritus. The disease is very common and not always easy to treat. Mainstay therapeutics are antihistamines, which show poor response rates (about 20%-50%) when used in standard dosage. The up-dosing of antihistamines to four-times daily dose does improve the response rate. However, a significant percentage of patients still do not reach sufficient symptom control.

• Registration Number: EUCTR2007-007657-31-DE
• Lead Sponsor: Charité-University Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-26
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Outpatients with moderate to severe spontaneous CU defined by UAS of =15 (under the maximum labelled dose of a non-sedating antihistamine.
Resistant to standard treatment with antihistamines after a minimum of 7 days therapy with the maximum labelled dose of a non-sedating antihistamine (levocetrizine, cetiricine, fexofenadine, desloratidine, loratidine, ebastine, mizolastine
Aged over 18 years
Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year) during the study and 3 months thereafter

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy or lactation
Participation in another clinical trial within the last 30 days
Body weight < 47 kg
Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
Skin symptoms caused primarily by physical urticaria
Urticaria vasculitis
Known hypersensitivity to miltefosine
Gastrointestinal disturbances which may influence oral resorption (e.g. chronic diarrhoea diseases, congenital malformations or major surgical resection of gastrointestinal tract).
History within 5 years or presence of myocardial infarction or any other major cardiac disorder.
Serum-creatinine and/or BUN 1.5 times above the upper reference value)
GOT and/or GPT and/or alkaline phosphatase 3 times above the upper reference value).
Sjögren-Larsson-Syndrome.
Malignancy within the last 5 years requiring chemotherapy or radiation therapy.
Mental disorders
Drug or alcohol dependency
Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study in the 4 weeks before start of treatment and during the study (investigator’s decision).
Immunodeficiency including HIV
During the past 7 days before start of treatment and during the study
Topical steroids
H2 antihistamines
Leukotriene antagonists
H1 antihistamine other then basic therapy
During the past 2 weeks before start of treatment and during the study
Ketotifen
Doxepin
During the past 4 weeks before start of treatment and during the study
Systemic corticosteroids
UV therapy including PUVA
Systemic immunosuppressives including corticosteroids, immunomodulators, immunostimulants
During the past 12 weeks before start of treatment and during the study
Astemizole
Tranquilizers, antidepressants, sedatives, hypnotics, antiepileptics and other CNS active agents

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of dosages of up to 150 mg miltefosine compared to placebo;Secondary Objective: To evaluate the safety of dosages of up to 150 mg miltefosine compared to placebo ;Primary end point(s): Primary Efficacy:<br>Urticaria symptoms (wheel and itching) as assessed by the urticaria activity score (UAS).<br>Secondary Efficacy:<br>Global assessment by a visual analogue scale (VAS)<br>