neuropathy, neuritis, leprosy
Conditions
Interventions
Trial 1:
Patients receiving prednisolone will start at a dose of 1 mg/kg/day, taken in the morning. To allow better comparison of treatment outcomes, two weight groups are discerned, one less than 50
Sponsors
Royal Tropical Institute
Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Trial 1: General: All newly diagnosed leprosy patients who can be followed will be eligible for inclusion in the trials. The following groups of patients can be included in trial 1: 1. Any patient who has signs of sub-clinical sensory or motor impairment (see Annex); 2. Optional, if there is sufficient time available for testing at 1, 2 or 3 months after starting MDT: Patients who on initial tests have normal nerves, but who may develop subclinical NFI within the first 3 months following diagnosis. Trial 2: All diagnosed leprosy patients, irrespective of MDT duration/status, who can be followed-up, will be eligible for inclusion in the trials. The following groups of patients can be included in trial 2: 1. Any among the above who have signs of clinical sensory or motor impairment of recent onset (= < 6 months duration) (see diagnostic criteria); 2. Patients from trial 1 who had a clinical outcome in the first 3 months (and only those who have been in the placebo arm, as demonstrated by later decoding, will be taken into the analysis of trial 2).
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Any patient refusing informed consent; 2. Any patient with a single skin lesion on the trunk as the only sign of leprosy; 3. Any patient over 60 or under 15; 4. Women with known pregnancy at the time of diagnosis; 5. People with known other conditions that may affect the peripheral nervous system (e.g. diabetes, alcohol abuse, HIV/AIDS, carpal tunnel syndrome, peripheral nerve injuries); 6. Any patients for whom steroids would be indicated for reasons other than a recent nerve function impairment. Trial 1, specific exclusion criteria: 1. Any patients with sensory or motor impairment by MFT or VMT in any nerve tested; 2. Any patient requiring steroid treatment for skin-only reversal reaction or ENL. Trial 2, specific exclusion criteria: 1. Any patients with old (> 6 months duration) sensory or motor impairment by MFT or VMT in any nerve tested, and not having any recent nerve function impairment (MFT or VMT); 2. Patients with skin-only reactions or ENL; 3. Patients previously enrolled in Trial 1, who have been in the treatment arm of Trial 1 (this will become clear at the moment of analysis at the end of the trials).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trial 1: Proportion of patients developing clinical neuropathy as defined by MFT/VMT change. Trial 2: Proportion of patients with restored nerve function as measured by MFT/VMT (all nerves). | — |
Secondary
| Measure | Time frame |
|---|---|
| Trial 1: 1. Proportion of patients with recovered nerve function (all nerves, absence of SC-NFI); 2. Proportions of patients with improved, unchanged or deteriorated SC NFI scores respectively (not back to normal WDT and/ or NCV); 3. Proportions of patients with recovered, improved, unchanged or deteriorated score of a given nerve; 4. Proportion of patients with serious adverse events/ other complications leaving the trial; 5. Spontaneous recovery of nerve function as assessed by nerve conduction or thermal testing (placebo group). Trial 2: 1. Proportion of patients with adverse effects or other complications, prompting removal from the trial; 2. Proportion of patients with ‘recovered’ improved, ‘unchanged’ or deteriorated function of a given nerve (e.g ulnar nerve); 3. Proportion of patients with changed (improved, unchanged, deteriorated) composite nerve scores; 4. Proportion of patients with changed reaction severity scores; 5. Proportion of patients with ‘changed’ SALSA and PP scale scores. | — |
Contacts
Public ContactErik Post
Wibautstraat 137J
Outcome results
None listed