A phase II trial to investigate the safety of early high dose methylprednisolone in acute leprous neuritis and leprosy type 1 reactions with neuritis in Nepal
| ISRCTN | ISRCTN31894035 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31894035 |
| Secondary identifying numbers | 4022 |
- Submission date
- 04/12/2005
- Registration date
- 04/04/2006
- Last edited
- 03/02/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
Leprosy is caused by a bacterium and is curable with a combination of antibiotics known as multi-drug therapy that patients take for 6 or 12 months. However, many leprosy patients experience inflammation in their skin and/or nerves, which may occur even after successful completion of multi-drug therapy. These episodes of inflammation are called leprosy Type 1 reactions. Type 1 reactions are an important complication of leprosy because they may result in nerve damage that leads to disability and deformity. Type 1 reactions require treatment with immunosuppressive agents such as corticosteroids. The best dose and duration of corticosteroid treatment is currently unclear. The aim of this study is to see if it would be safe to use a large dose of a corticosteroid called methylprednisolone for three days at the start of 16 weeks of treatment with the corticosteroid prednisolone.
Who can participate?
Patients age 16-65 with leprosy Type 1 reactions and nerve damage present for less than six months.
What does the study involve?
Participants are randomly allocated to one of two groups. One group is treated with methylprednisolone intravenously (given into a vein) and placebo (dummy) tablets for the first three days of treatment. The other group is treated with a placebo intravenous infusion and prednisolone tablets for the first three days of treatment. Both groups are then treated with prednisolone tablets for 16 weeks.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
London School of Hygiene and Tropical Medicine (UK)
When is the study starting and how long is it expected to run for?
December 2005 to December 2007
Who is funding the study?
LEPRA (UK), American Leprosy Mission (USA), Hospital for Tropical Diseases London (UK)
Who is the main contact?
Dr Diana Lockwood
diana.lockwood@lshtm.ac.uk
Contact information
Scientific
Clinical Research Unit
Department of Infectious Diseases
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| diana.lockwood@lshtm.ac.uk |
Study information
| Study design | Randomised double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A phase II trial to investigate the safety of early high dose methylprednisolone in acute leprous neuritis and leprosy type 1 reactions with neuritis in Nepal |
| Study acronym | MPSTUDY |
| Study hypothesis | Early high dose steroids will improve recovery of acute neuritis and prevent relapse |
| Ethics approval(s) | 1. London School of Hygiene and Tropical Medicine, 28/11/2005, ref: 4022 2. Nepal Medical Research Council |
| Condition | Leprosy |
| Intervention | Study arm receives intravenous (IV) methylprednisolone in the first three days of type 1 reaction or acute neuritis treatment. The control arm receives a standard treatment of 40 mg prednisolone plus a normal saline (placebo) infusion. Those receiving IV methylprednisolone are given placebo tablets to ensure complete blinding. The following sixteen weeks of treatment are identical for both groups. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Methylprednisolone, prednisolone |
| Primary outcome measure | Nerve function |
| Secondary outcome measures | Amount of additional steroid required |
| Overall study start date | 07/12/2005 |
| Overall study end date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Participant inclusion criteria | 1. Those with type 1 reaction with new nerve function impairment 2. Age 16-65 years |
| Participant exclusion criteria | 1. Type 1 reaction without new nerve function impairment 2. Systemic corticosteroids in the preceding three months 3. Contraindications to steroids 4. Pregnancy 5. Severe active infection 6. Severe intercurrent illness |
| Recruitment start date | 07/12/2005 |
| Recruitment end date | 31/12/2007 |
Locations
Countries of recruitment
- England
- Nepal
- United Kingdom
Study participating centre
WC1E 7HT
United Kingdom
Sponsor information
University/education
Keppel Street
London
WC1E 7HT
England
United Kingdom
| diana.lockwood@lshtm.ac.uk | |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Charity
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/04/2011 | Yes | No | |
| Results article | results | 01/04/2012 | Yes | No |
Editorial Notes
03/02/2016: Plain English summary added.
