Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria

NCT ID: NCT01170949

Last Updated: 2016-12-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-04-30

Brief Summary

Randomised, double-blind, placebo-controlled study evaluating the effects of miltefosine on skin lesions in patients with treatment resistant chronic urticaria. Treatment resistance is defined by insufficient treatment response after a minimum of 1 week therapy with the maximum labelled dose of a non-sedating antihistamine. Eligible subjects will be enrolled at baseline 8 (+/- 1) days after screening. 75 Patients will be randomised in a 2:1 ratio to one of the following treatment groups as add-on to the ongoing therapy with a non-sedating antihistamine for treatment period of 4 weeks: 25 placebo and 50 active drug Efficacy and safety evaluations are done at baseline day 7, 14, 21 safety, only) and 28 (or end of treatment) and at day 56 (28 days after end of treatment).

Conditions

Chronic Urticaria

Keywords

urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Miltefosine

Group Type: EXPERIMENTAL

Miltefosine

Intervention Type: DRUG

50 or 100 or 150mg per day

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Miltefosine

50 or 100 or 150mg per day

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

Pregnancy or lactation Participation in another clinical trial within the last 30 days Body weight ≤ 45 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 Retinal pathology Leishmaniasis 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 that interfere with the evaluation of study end-points 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 10 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, except treatment with tricyclics that is stable for at least 12 weeks prior to screening and throughout the trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: collaborator

Marcus Maurer

OTHER

Sponsor Role: lead

Responsible Party

Marcus Maurer

Professor Dr.Marcus Maurer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Markus Magerl, MD

Role: PRINCIPAL_INVESTIGATOR

Charité University, Berlin

Locations

Charité University

Berlin, , Germany

Countries

Germany

Other Identifiers

EudraCT Number: 2007-007657-31

Identifier Type: -

Identifier Source: secondary_id

MIARCU 01/2008

Identifier Type: -

Identifier Source: org_study_id