Ciclosporin in the Management of New Type 1 Reactions in Leprosy

Phase 2

Completed

• Conditions: Leprosy
• Interventions: Drug: Ciclosporin; Drug: Prednisolone

• Registration Number: NCT00919815
• Lead Sponsor: London School of Hygiene and Tropical Medicine

Brief Summary

Study 1A: Ciclosporin in the management of new Type 1 Reactions in Leprosy

Objective: A randomised double blind controlled trial comparing Ciclosporin and Prednisolone,to determine whether treatment with Ciclosporin gives the same outcome in the treatment of new Type 1 Reactions as Prednisolone.

Detailed Description

We tested our hypothesis that ciclosporin would be as effective as prednisolone in the treatment of patients with leprosy reactions and nerve function impairment and that patients treated with ciclosporin would have fewer side effects than patients treated with prednisolone. A randomised controlled trial comparing ciclosporin and prednisolone in the treatment of acute leprosy T1R was conducted.

Study Timeline

• Study First Submitted: 2009-06-11
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Study Start: 2010-08
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-21
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

• Individuals with clinical evidence of T1R with new nerve function impairment (NFI).
• Aged 18-65
• Weigh more than 30Kg

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ciclosporin arm	Ciclosporin	ciclosporin reducing regimen lasting 24 weeks (additional prednisolone given for the first four weeks)
prednisolone	Prednisolone	standard course of prednisolone given in a reducing regimen over 24 weeks

Primary Outcome Measures

Name	Time	Method
improvement in nerve function and Clinical Severity Score	at week 4, 20, 28

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	up to 36 weeks
Number of T1R recurrence episodes per patient in each treatment arm	up to 36 weeks
Severity of T1R recurrence for patients in each treatment arm	up to 36 weeks
extra prednisolone needed to control reaction	up to 36 weeks
6. Difference in score in Quality of Life assessment between start and end of treatment for patients in each treatment arm	36 weeks
Mean time to recurrence of T1R for patients in each treatment arm	up to 36 weeks

Trial Locations

Locations (1)

Alert Hospital; 🇪🇹 Addis Abeba, Ethiopia