LeprosyPhase 2NCT00919542
Ciclosporin in the Management of New Erythema Nodosum Leprosum
A Phase 2 study testing Ciclosporin and prednisolone in people with Leprosy, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
Trial summary
Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Leprosy
- What is being tested?
- Ciclosporin and prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEthiopia
- Study dates
- Jul 2010to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with clinical evidence of new ENL
- Aged 18-65
- Weigh more than 30Kg
Who cannot join
- Unwillingness to give informed consent
- Patients with severe active infections such as tuberculosis
- Pregnant or breastfeeding women (see Appendix II)
- Those with renal failure, abnormal renal function, hypertensive
- Patients taking thalidomide currently or within the last 3 months
- Patients not willing to return for follow-up
- Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
- HIV positive patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.
Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum
Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
Read the detailed description
A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
- Conditions
- Leprosy
- Being tested
- Ciclosporin, prednisolone
- Keywords
- Leprosy, ENL, Erythema Nodosum Leprosum, Prednisolone, Ciclosporin
- Medical subject headings
- Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclosporinDrug
Also called cyclosporin, Cyclosporin A
Ciclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks)
prednisoloneDrug
Also called corticosteroids
prednisolone 40mg daily then reducing regimen over 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| prednisolone | Active comparator | standard course of prednisolone given in a reducing regimen over 16 weeks Receives: Drug: prednisolone |
| Ciclosporin | Experimental | ciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks) Receives: Drug: Ciclosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ENL recurrence episodes per patient
Measured: up to 32 weeks
Secondary outcomes (4)
Mean time to ENL recurrence after initial control
Measured: up to 32 weeks
Amount of additional prednisolone required by patients
Measured: up to 32 weeks
Frequency of adverse events for patients in each treatment arm
Measured: up to 32 weeks
Difference in score in Quality of Life assessment between start and end for patients in each treatment arm
Measured: up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeprosyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia
- Responsible party
- Principal investigator, Saba Lambert, London School of Hygiene and Tropical Medicine
- Investigators
- Diana NJ Lockwood, MBchB, Study director, London SHTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919542
- Sponsor's protocol ID
- ITCRBY24-ENLA
- Status last verified
- Mar 2015
- First submitted
- 11 Jun 2009
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot (Double Blind Controlled) Study Randomizing Patients With New Acute ENL to Treatment Either With Ciclosporin or Prednisolone.
- ClinicalTrials.gov ID
- NCT00919542
- Acronym / sponsor ID
- ITCRBY24-ENLA
- Conditions
- Leprosy
- Keywords
- Leprosy, ENL, Erythema Nodosum Leprosum, Prednisolone, Ciclosporin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Homes and Hospitals of St Giles, Alert Hospital, Ethiopia, Armauer Hansen Research Institute, Ethiopia
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study 2A: Ciclosporin in the management of new Erythema Nodosum Leprosum
Objective: A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
Detailed description
A pilot (double blind controlled) study randomizing patients to treatment either with Ciclosporin or Prednisolone to assess the safety, tolerability and efficacy of Ciclosporin in the treatment of patients with new acute Type 2 reactions (ENL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prednisolone | Active comparator | Drug: prednisolonestandard course of prednisolone given in a reducing regimen over 16 weeks |
| Ciclosporin | Experimental | Drug: Ciclosporinciclosporin reducing regimen lasting 16 weeks (additional prednisolone given for the first four weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with clinical evidence of new ENL
- Aged 18-65
- Weigh more than 30Kg
Key exclusion criteria (8 listed)
- Unwillingness to give informed consent
- Patients with severe active infections such as tuberculosis
- Pregnant or breastfeeding women (see Appendix II)
- Those with renal failure, abnormal renal function, hypertensive
- Patients taking thalidomide currently or within the last 3 months
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 |
|---|---|---|
| CiclosporinAlso: cyclosporin, Cyclosporin ACiclosporin 7.5mg/kg - reducing regimen over 16 weeks (additional prednisolone given for the first four weeks) | Drug | Ciclosporin |
| prednisoloneAlso: corticosteroidsprednisolone 40mg daily then reducing regimen over 16 weeks | Drug | prednisolone |
Primary outcome
Number of ENL recurrence episodes per patient
Time frame: up to 32 weeks
4 secondary outcomes
Mean time to ENL recurrence after initial control
Time frame: up to 32 weeks
Amount of additional prednisolone required by patients
Time frame: up to 32 weeks
Frequency of adverse events for patients in each treatment arm
Time frame: up to 32 weeks
Difference in score in Quality of Life assessment between start and end for patients in each treatment arm
Time frame: up to 32 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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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.
Diana NJ Lockwood, MBchB study director
London SHTM
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 Ciclosporin and prednisolone in people with Leprosy, run by London School of Hygiene and Tropical Medicine at 1 site in Ethiopia.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 24 Mar 2015. 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 Ethiopia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of ENL recurrence episodes per patient (time frame: up to 32 weeks). 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 24 Mar 2015.