NCT03324035.

Study name	Treatment of neuropathic pain in leprosy: a randomized double blind controlled study
Methods	Double‐blind, placebo‐controlled, parallel, 2‐arm RCT
Participants	Presence of spontaneous pain of medium intensity in the last 24 hours with a minimum value of 4 in 10 on a numerical scale, with a maximum of 10 points (summed pain questionnaire) Duration of pain of at least 6 months Presence of neuropathic pain "pure" or of clearly dominant character (no other pain, or pain associated unimportant) Pain due to leprosy confirmed by clinical examination and/or appropriate electrophysiological examination n = 102
Interventions	Amitriptyline, flexible doses varying from 25‐75 mg Placebo, flexible doses from 1‐3 capsules
Outcomes	30% pain relief Pain intensity Neuropathic pain symptoms Quality of life AEs
Starting date	01 March 2017
Contact information	Daniel Ciampi Araujo de Andrade, MD, PhD, Principal Investigator, Pain Center coordinator, Department of Neurology, University of Sao Paulo, São Paulo, Brazil, University of Sao Paulo
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