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Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria (MIARCU)

Primary Purpose

Chronic Urticaria

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Miltefosine
Placebo
Sponsored by
Marcus Maurer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Urticaria focused on measuring urticaria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria Informed consent signed and dated 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 (levocetirizine, cetirizine, fexofenadine, desloratadine, loratadine, ebastine, mizolastine Aged more than 18 years Reliable method of contraception for both women of childbearing potential as well as men during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.

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

Sites / Locations

  • Charité University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Miltefosine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Urticaria Activity Score (% Change From Baseline)
The weekly UAS was calculated by adding the daily scores over one week. During the whole course of the study patients recorded the amount of wheals and the intensity of itching as well as the occurrence of swelling in ranges between 0 and 3. These daily scores were used to calculate urticaria activity scores (UAS) as follows: Daily UAS are calculated by adding the score points obtained for the symptom categories "number of wheals" and "intensity of pruritus". "Number of wheals" is scored as 0 = no wheals, 1 = some wheals (<20), 2 = moderate number of wheals (20-50), 3 = more than 50 wheals. "Intensity of pruritus" is scored as 0 = no itching; 1 = mild itching, not irritating; 2 = moderate itching, normal daily activity and sleep is possible; and 3 = severe itching, normal daily activity and sleep is impaired. The maximum score is 42.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2010
Last Updated
November 1, 2016
Sponsor
Marcus Maurer
Collaborators
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01170949
Brief Title
Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria
Acronym
MIARCU
Official Title
Randomised, Double-blind, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Study medication expired
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marcus Maurer
Collaborators
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria
Keywords
urticaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Miltefosine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Miltefosine
Intervention Description
50 or 100 or 150mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Urticaria Activity Score (% Change From Baseline)
Description
The weekly UAS was calculated by adding the daily scores over one week. During the whole course of the study patients recorded the amount of wheals and the intensity of itching as well as the occurrence of swelling in ranges between 0 and 3. These daily scores were used to calculate urticaria activity scores (UAS) as follows: Daily UAS are calculated by adding the score points obtained for the symptom categories "number of wheals" and "intensity of pruritus". "Number of wheals" is scored as 0 = no wheals, 1 = some wheals (<20), 2 = moderate number of wheals (20-50), 3 = more than 50 wheals. "Intensity of pruritus" is scored as 0 = no itching; 1 = mild itching, not irritating; 2 = moderate itching, normal daily activity and sleep is possible; and 3 = severe itching, normal daily activity and sleep is impaired. The maximum score is 42.
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Informed consent signed and dated 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 (levocetirizine, cetirizine, fexofenadine, desloratadine, loratadine, ebastine, mizolastine Aged more than 18 years Reliable method of contraception for both women of childbearing potential as well as men during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Magerl, MD
Organizational Affiliation
Charité University, Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité University
City
Berlin
ZIP/Postal Code
10179
Country
Germany

12. IPD Sharing Statement

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Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria

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