Urticaria 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.
Conditions
Interventions
Trade Name: Impavido
Product Name: Impavido
Pharmaceutical Form: Capsule*
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use
Sponsors
Charité-University Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: Urticaria symptoms (wheel and itching) as assessed by the urticaria activity score (UAS). Secondary Efficacy: Global assessment by a visual analogue scale (VAS) | — |
Countries
Germany
Outcome results
None listed