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

This study has been terminated.
(Study medication expired)
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01170949
First received: January 12, 2010
Last updated: July 27, 2010
Last verified: October 2008
  Purpose

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).


Condition Intervention Phase
Chronic Urticaria
Drug: Miltefosine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Urticaria activity score [ Time Frame: 2,3,4 and 8 weeks ] [ Designated as safety issue: No ]
    Composite score of number of weals and itch


Estimated Enrollment: 101
Study Start Date: September 2008
Study Completion Date: April 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Miltefosine Drug: Miltefosine
50 or 100 or 150mg per day
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170949

Locations
Germany
Charité University
Berlin, Germany, 10179
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Markus Magerl, MD Charité University, Berlin
  More Information

No publications provided

Responsible Party: Marcus Maurer, MD, Allergie-Centrum-Charité
ClinicalTrials.gov Identifier: NCT01170949     History of Changes
Other Study ID Numbers: MIARCU 01/2008, EudraCT Number: 2007-007657-31
Study First Received: January 12, 2010
Last Updated: July 27, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
urticaria

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Histamine Antagonists
Miltefosine
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antineoplastic Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on April 21, 2014