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IRCT20090613002027N21 IRCT 2023-05-09 Mazandaran University of Medical Sciences Evaluation of the efficacy and safety of lacosamide to duloxetine in the treatment of taxanes- induced peripheral neuropathy Evaluation of the efficacy and safety of the addition of lacosamide to duloxetine in the treatment of taxanes- induced peripheral neuropathy: a randomized double-blind placebo-controlled trial 2023-05-05 anticipated 60 Complete https://irct.ir/trial/58496 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples will be selected by continuous sampling and the patients will be placed in two control and test groups by Block Balanced Randomization (BBR) method. Using the free web system http://www.randomization.com/, the allocation sequence will be done. In this way, the number of subjects in each block is determined to be 4 and the letter A will be considered for the control group and the letter B will be considered for the test group, and the allocation sequence will be created for 60 samples in 15 blocks of 4 with the combination of letters A and B. became. In order to hide the allocation (Allocation Concealment) using the random number table, a random 4-digit number will be determined as the unique code of each patient so that the grouping status of the patient (A or B) remains hidden. The information about the blocks and the specific code of each patient will be available only for the head of the research, Blinding description: This study will be double-blind and the patient and the doctor will not know about the drug used (lacosamide or placebo). 2-3 Taxane-induced neuropathy. Intervention 1: Intervention group who suffers from taxane-induced neuropathy, the standard treatment is duloxetine 30 mg daily in the first week and then 60 mg daily with lacosamide drug of Abidi Pharmaceutical Company (UNIMIDE®) 100 mg tablet every 12 hours and from the second week if tolerated to 300 mg daily. From the third week to 400 mg daily (200 mg every 12 hours), continue until the end of the third month, and then reduce the weekly dose of 100 mg per day until discontinuation of the drug at the end of the fourth month. At the end of three months, duloxetine is first reduced to 30 mg daily for one week and then discontinued. Intervention 2: Control group who suffers from taxane-induced neuropathy: The standard treatment is duloxetine 30 mg daily for the first week and then 60 mg daily with placebo of lacosamide tablets (made in Abidi Pharmaceutical Company) every 12 hours for one week, from the second week 2 in the morning one night and from the third week two every 12 hours and continue until the end. The third month and then reduce the weekly dose of one placebo pill per day until the drug is stopped at the end of the fourth month. At the end of the third month, duloxetine is first reduced to 30 mg daily for one week and then discontinued. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no plan for publishing the protocol of the study because it is accessible in IRCT.
public Ebrahim Salehifar
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
Sari Iran (Islamic Republic of) 4818893716 +98 11 3354 3083 esalehifar52@gmail.com Mazandaran University of Medical Sciences scientific Ebrahim Salehifar
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar square, Sari, Mazandaran Province
Sari Iran (Islamic Republic of) 4818893716 +98 11 3354 3083 esalehifar52@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) People aged 18 years and older Patients with taxane-induced peripheral neuropathy Existence of moderate to severe neuropathic pain with PI-NRS score ≥4 Normal baseline ECG 18 years no limit Both Patients with a history of neurological diseases such as hereditary or acquired neuropathies Patients with neuropathic pain due to conditions such as post-herpes neuralgia, uncontrolled diabetes with neuropathy, trigeminal neuralgia, spinal cord injury or other neurological diseases, known vitamin B12 deficiency, amyloidosis, neuromuscular diseases and connective tissue diseases Creatinine clearance less than 30 ml / min Severe liver failure History of allergy to lacosamide or duloxetine History of duloxetine or lacosamide use Evidence of severe systemic disease patients with epilepsy Drugs that interact with the study drugs including tricyclic antidepressants (TCAs), norepinephrine-specific serotonin reuptake inhibitors (SNRIs), and sodium channel blockers in the past three months Use of monoamine oxidase inhibitors (MAOIs) in the last fourteen days or simultaneously Drugs that interact with the study drugs including atazanavir, siponimod, carbamazepine, phenobarbital, phenytoin, amiodarone, sotalol, antiarrhythmic drugs that increase QT interval, including class IA and IC, beta-blockers and non-dihydropyridine calcium channel blockers, lidocaine, and mexiletine Pregnant or lactating women Dissatisfaction with participating in the study Treatment - Drugs Placebo Intervention group who suffers from taxane-induced neuropathy, the standard treatment is duloxetine 30 mg daily in the first week and then 60 mg daily with lacosamide drug of Abidi Pharmaceutical Company (UNIMIDE®) 100 mg tablet every 12 hours and from the second week if tolerated to 300 mg daily. From the third week to 400 mg daily (200 mg every 12 hours), continue until the end of the third month, and then reduce the weekly dose of 100 mg per day until discontinuation of the drug at the end of the fourth month. At the end of three months, duloxetine is first reduced to 30 mg daily for one week and then discontinued. Control group who suffers from taxane-induced neuropathy: The standard treatment is duloxetine 30 mg daily for the first week and then 60 mg daily with placebo of lacosamide tablets (made in Abidi Pharmaceutical Company) every 12 hours for one week, from the second week 2 in the morning one night and from the third week two every 12 hours and continue until the end. The third month and then reduce the weekly dose of one placebo pill per day until the drug is stopped at the end of the fourth month. At the end of the third month, duloxetine is first reduced to 30 mg daily for one week and then discontinued. The severity of neuropathy based on CTCAE. Timepoint: Measurement of severity of neuropathy based on CTCAE at baseline and end of week 6 and end of week 12 of Lacosamide / placebo use. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Pain rate based on Numeric pain rating scale. Timepoint: Measurement of pain rate based on Numeric pain rating scale at baseline and end of week 6 and end of week 12 of Lacosamide/placebo use. Method of measurement: Using Numeric pain rating scale. The severity of neuropathy based on FACT/GOG-Ntx. Timepoint: Measurement of severity of neuropathy based on FACT/GOG-Ntx at baseline and end of week 6 and end of week 12 of Lacosamide / placebo use. Method of measurement: Using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group – Neurotoxicity (FACT/GOG-Ntx). The severity of neuropathy based on Neuropathy pain scale. Timepoint: Measurement of severity of neuropathy based on Neuropathy pain scale at baseline and end of week 6 and end of week 12 of Lacosamide/placebo use. Method of measurement: Using Neuropathy pain scale. Quality of life based on EORTC QLQ-C30. Timepoint: Measurement of Quality of life-based on EORTC QLQ-C30 at baseline and end of week 6 and end of week 12 of Lacosamide/placebo use. Method of measurement: Using EORTC Quality of Life Study Group version 3. Averse effects. Timepoint: Record adverse effects at any time during the study. Method of measurement: With monitoring the patient. Mazandaran University of Medical Sciences Approved 2022-04-12 Ethics Committee of Mazandaran University of Medical Sciences Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar Square, Sari, Mazandaran Province Sari Mazandaran Iran (Islamic Republic of)