Treatment of Neuropathic Pain in Leprosy

• Status: Recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborator: Cristália Produtos Químicos Farmacêuticos Ltda.
• Treatments: Amitriptyline; Amitriptyline, perphenazine drug combination; Tramadol

Criteria

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 least 4 scores in 7 days);

• Patients who can't be followed on a regular basis or that miss the appointments (we will give a 7 day tolerance for each appointment);

• Documented abuse of psychoactive drugs or alcohol;

• History of past or actual psychosis;

• Actual diagnosis of major depression following the DSM-IV criteria;

• Language and cognitive deficits that are capable of interfering with the understanding of the study;

• Patients not affiliated with a social security scheme (beneficiary or recipient);

• Patients who refuses to sign or are unable to understand the informed consent, under guardianship;

• Participation in other research protocol involving the use of any medication during the 30 days preceding the inclusion in the project.