Treatment of Neuropathic Pain in Leprosy (NCT03324035) | Clinical Trial Compass
UnknownPhase 3
Treatment of Neuropathic Pain in Leprosy
Brazil102 participantsStarted 2017-03-01
Plain-language summary
Despite large efforts to eradicate leprosy, this curable mycobacterial infection still affects 250,000 new individuals annually. Half of the globe's leprosy patients live in Brazil and India. In 2013, 33,033 new leprosy cases diagnosed in Brazil, with an average incidence of 1.05 cases / 10 000 inhabitants. Recently a new concept of care after cure has called attention for severe pain in previously treated patients, particularly, neuropathic pain. Even so, until now no single drug has been studied for the treatment of pain in this patients, and the use of drugs is based on the study of other diseases. We designed the first placebo-controlled, double blinded randomized trial in the use of flexible-dose amitriptyline (tricyclic antidepressant) for the treatment of neuropathic pain related to leprosy
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Ability to properly understand the Portuguese language, being able to understand the methodology of the study and questionnaires
* Having provided their consent in writing of their participation in the study
Exclusion Criteria:
* Linked to the disease in study:
* Neuropathic pain from other causes that not Hansen's disease (Diabetes, HIV, and after chemotherapy);
* Linked to the treatment:
* Hypersensitivity to amitriptyline and tramadol;
* Ongoing treatment with monoamine oxidase inhibitors (MAOIs);
* Cardiac and ophthalmologic disorders that contraindicate the use of amitryptiline;
* Pregnant or nursing women, or even women of childbearing age without the use of contraceptives.
* General
* Other pain with intensity higher then the neuropathic one;
* Ant other condition that may interfere with the evaluation of the study;
* Patients who have not given or signed the informed consent form;
* Incorrectly completion of the self-assessment of pain notebook in the period between inclusion and randomization (at lea…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in pain intensity of 30% from baseline measured by verbal analog scale (VAS)