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IRCT20250211064704N1 IRCT 2025-05-21 Nishtar Medical University and Hospital Multan Efficacy of lacosamide in patients with diabetic neuropathy Efficacy of lacosamide in patients with diabetic neuropathy 2025-03-01 anticipated 60 Complete https://irct.ir/trial/81853 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomized individually into two groups (Group A: Lacosamide, Group B: Placebo) using a simple randomization method. A computer-generated random number sequence will be prepared in advance using randomization software (e.g., www.randomizer.org). The sequence will be generated by a person not involved in participant enrollment. Allocation will be concealed using sequentially numbered, sealed, opaque envelopes (SNOSE) containing the group assignment. Each envelope will be opened only after the patient has been enrolled and consented. The envelopes will be identical and opaque to prevent selection bias, ensuring allocation concealment. This process guarantees that the assignment remains unpredictable and unbiased, Blinding description: This will be a double-blinded study in which both the participants and the investigator assessing outcomes will be blinded to the treatment allocation. Lacosamide and placebo tablets will be identical in appearance, packaging, color, and size, and will be labeled with coded identifiers (e.g., A or B) by a third party not involved in participant recruitment or outcome assessment. The medication codes will be kept confidential and secured until the completion of data analysis. The investigator responsible for enrolling participants and recording outcomes will not have access to the allocation code. The blinding will be maintained throughout the study to minimize performance and assessment bias. Unblinding will only occur in case of medical emergency or serious adverse event where knowledge of the treatment is necessary for clinical decision-making. 2 Diabetic Neuropathy. Intervention 1: Intervention group: Participants will receive Lacosamide tablets (C13H18N2O3), manufactured by Zakfas Pharmaceuticals (Pvt.) Ltd, Pakistan. Treatment will begin at 100 mg orally once daily, increasing weekly in 100 mg increments to a maximum of 400 mg/day (200 mg twice daily): Week 1: 100 mg once daily; Week 2: 100 mg twice daily; Week 3: 200 mg morning, 100 mg evening (300 mg/day); Week 4–12: 200 mg twice daily. Treatment will continue for 12 weeks. Medication will be administered orally. Tablets will be identical in appearance to placebo. Participants will be assessed every 4 weeks for adherence, side effects, and outcomes. Intervention 2: Control group: Participants will receive placebo tablets, identical in size, shape, and color to the Lacosamide tablets, manufactured by Zakfas Pharmaceuticals (Pvt.) Ltd, Pakistan. The placebo will be administered orally for 12 weeks, following the same titration schedule as the intervention group: Week 1: 1 tablet once daily; Week 2: 1 tablet twice daily; Week 3: 2 tablets in the morning, 1 in the evening (to mimic 300 mg/day dosing); Week 4–12: 2 tablets twice daily. The placebo dosing schedule will simulate the active drug regimen to maintain blinding. Participants will be monitored every 4 weeks for adherence, side effects, and outcome assessments. Yes - There is a plan to make this available What will be shared: Study Protocol (methods, randomization details). Statistical Analysis Plan (how data will be analyzed). Summary Results (aggregate data, no personal identifiers). De-identified Participant Data (only if ethically approved). When: After publication of primary results, typically 6–12 months post-study completion. Data will be available for at least 5 years after publication. To whom: Researchers; Healthcare providers . Conditions: Ethical & Confidentiality Considerations. De-identification: All participant data will be anonymized to prevent identification. Ethical Approval: Data sharing will comply with institutional IRB guidelines. Patient Consent: Informed consent forms will include a clause about potential data sharing. Where to obtain: Institutional Repository: Nishtar Medical University database (if available). Public Repositories: WHO ICTRP, ClinicalTrials.gov, Dryad, or Figshare. Journal Supplementary Files: If required by the journal where the study is published. How to obtain: Researchers must submit a formal request via email to the principal investigator. Requests should include: Purpose of data use, Ethical approval (if applicable), Data security measures. Access will be granted only for non-commercial, research purposes. Comments:
public Dr Awais Akram
No 1 , Nishtar street, Nishtar Hospital Road, Gilani Colony Nishtar Multan
Multan Pakistan 66000 +92 335 6025056 awais.szmc@gmail.com Nishtar Medical University and Hospital Multan scientific Dr Awais Akram
House number 08, Adjacent To PATTAN Development organisation, Awais Street, Yummy ice cream Road, Bahadarpur
Multan Pakistan 60700 +92 335 6025056 awais.szmc@gmail.com Nishtar Medical University and Hospital Multan Pakistan known case of Diabetes with equivalent or more than 5 years of diabetes Patients of either gender Age 20-60 years 20 years 60 years Both Patient taking other medicine for pain (TCA, lidocaine patch, mexiletine hydrochloride, tramadol, opioids, AEDs and NSAIDS) Patients with cardio-vascular disease pregnant / breastfeeding women Patient with renal impairment Patients with liver functioning enzymes greater than twice of normal E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified Treatment - Drugs Placebo Intervention group: Participants will receive Lacosamide tablets (C13H18N2O3), manufactured by Zakfas Pharmaceuticals (Pvt.) Ltd, Pakistan. Treatment will begin at 100 mg orally once daily, increasing weekly in 100 mg increments to a maximum of 400 mg/day (200 mg twice daily): Week 1: 100 mg once daily; Week 2: 100 mg twice daily; Week 3: 200 mg morning, 100 mg evening (300 mg/day); Week 4–12: 200 mg twice daily. Treatment will continue for 12 weeks. Medication will be administered orally. Tablets will be identical in appearance to placebo. Participants will be assessed every 4 weeks for adherence, side effects, and outcomes. Control group: Participants will receive placebo tablets, identical in size, shape, and color to the Lacosamide tablets, manufactured by Zakfas Pharmaceuticals (Pvt.) Ltd, Pakistan. The placebo will be administered orally for 12 weeks, following the same titration schedule as the intervention group: Week 1: 1 tablet once daily; Week 2: 1 tablet twice daily; Week 3: 2 tablets in the morning, 1 in the evening (to mimic 300 mg/day dosing); Week 4–12: 2 tablets twice daily. The placebo dosing schedule will simulate the active drug regimen to maintain blinding. Participants will be monitored every 4 weeks for adherence, side effects, and outcome assessments. Mean post-treatment pain score in patients with diabetic neuropathy after receiving either Lacosamide or placebo for 12 weeks. Timepoint: 12 weeks (at the end of the treatment period). Method of measurement: Pain intensity will be measured using the Visual Analogue Scale (VAS), where 0 indicates no pain and 10 indicates worst possible pain. The outcome will be assessed by a blinded assessor who is unaware of the group allocation. Nishtar Medical University and Hospital Multan Approved 2025-03-10 Ethical Review Board/committee Nishtar Medical University, Multan No 1 , Nishtar street, Nishtar Hospital Road, Gilani Colony Nishtar Multan Multan Punjab Pakistan