Efficacy of lacosamide in patients with diabetic neuropathy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250211064704N1

Enrollment

Registered

2025-05-21

Start date

2025-03-01

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathy. Type 2 diabetes mellitus with diabetic neuropathy, unspecified

Interventions

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 d

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 w

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

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

Inclusion criteria: known case of Diabetes with equivalent or more than 5 years of diabetes Patients of either gender Age 20-60 years

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Pakistan

Contacts

Public ContactDr Awais Akram

Nishtar Medical University and Hospital Multan

awais.szmc@gmail.com+92 335 6025056

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026