Chronic UrticariaPhase 2MIARCUNCT01170949
Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria
A Phase 2 study testing Miltefosine in people with Chronic Urticaria, run by Marcus Maurer at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- Miltefosine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Apr 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-blind, Placebo-controlled Study
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
- Being tested
- Miltefosine, Placebo
- Keywords
- urticaria
- Medical subject headings
- Chronic Urticaria, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiltefosineDrug
50 or 100 or 150mg per day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Miltefosine | Experimental | Not described Receives: Drug: Miltefosine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2008
- Study completionApr 2010
Why it stopped: Study medication expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcus Maurer
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Responsible party
- Sponsor-investigator, Marcus Maurer, Charite University, Berlin, Germany
- Investigators
- Markus Magerl, MD, Principal investigator, Charité University, Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170949
- Sponsor's protocol ID
- MIARCU 01/2008
- Other IDs
- EudraCT Number: 2007-007657-31
- Acronym
- MIARCU
- Status last verified
- Nov 2016
- First submitted
- 12 Jan 2010
- Last updated
- 26 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01170949
- Acronym / sponsor ID
- MIARCU / MIARCU 01/2008
- Conditions
- Chronic Urticaria
- Keywords
- urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study medication expired
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Marcus MaurerUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany
- Study start
- Sep 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Posted 26 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miltefosine | Experimental | Drug: Miltefosine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miltefosine50 or 100 or 150mg per day | Drug | Miltefosine |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Urticaria Activity Score (% Change From Baseline)
Time frame: Day 28
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Chronic Urticaria
Not yet recruitingObservational study
Remibrutinib in Real-world Clinical Practice - a South Korea Sub-Study
Chronic Spontaneous Urticaria
RecruitingPhase 3
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Chronic Inducible Urticaria, Cold Urticaria
Enrolling by invitationPhase 3
Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of THB335 in Adults With Chronic Spontaneous Urticaria (CSU)
Chronic Spontaneous Urticaria (CSU), Chronic Idiopathic Urticaria
RecruitingPhase 1
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
Healthy Subjects, Cold Urticaria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Magerl, MD principal investigator
Charité University, Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Miltefosine in people with Chronic Urticaria, run by Marcus Maurer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urticaria Activity Score (% Change From Baseline) (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2016.