Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria

Chronic Urticaria Clinical Trial

— MIARCU  

Official title:

Randomised, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01170949
• Other study ID #: MIARCU 01/2008
• Secondary ID: EudraCT Number:
• Status: Terminated
• Phase: Phase 2
• First received: January 12, 2010
• Last updated: July 27, 2010
• Start date: September 2008
• Est. completion date: April 2010

Study information

• Verified date: October 2008
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: April 2010
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Urticaria
• Urticaria

Intervention

Drug:
• Miltefosine
50 or 100 or 150mg per day
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Charité University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urticaria activity score	Composite score of number of weals and itch	2,3,4 and 8 weeks	No