Antineuralgic Effect of Lacosamide (Vimpat) in Trigeminal Neuralgia Patients

Phase 4

Recruiting

• Conditions: Trigeminal neuralgia (TN) is a rare neuropahic condition with symptoms as brief, abrupt onset electric shock-like pain in the area of trigeminal nerve innervation.; Trigeminal neuralgia; Neuropathic pain

• Registration Number: TCTR20210811002
• Lead Sponsor: eurosciences Research and Development Group, Khonkaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-11
• Study Completion: 2021-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Adult
2. Diagnosed as trigeminal neuralgia according to International Classification of Headache Disorder 3rd edition (ICHD-3)
3. Numeric rating scale of pain higher than 4
4. Never received any treatment or have not taken any drugs in last 4 weeks
5. Physical condition is categorized as American Society of Anesthesiologist (ASA classification) 1 or 2
6. Can communicate in Thai

Exclusion Criteria

1. History of microvascular decompression surgery without recurred symptom
2. Impaired physical condition or psychological problems
3. Pregnancy and lactation
4. History of suicide commitment
5. Impaired liver or kidney functions
6. History of experimental drug allergy
7. Unwilling to join the sudy
8. Could not come to follow up regularly

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity Baseline, 2weeks, 4 weeks and 8 weeks after numeric rating scale

Secondary Outcome Measures

Name	Time	Method
Physical function Baseline, 2weeks, 4 weeks and 8 weeks after BPI-facial questionnaire,Emotional function Baseline, 2weeks, 4 weeks and 8 weeks after Thai Hospital anxiety and depression scales questionnaire,Adverse effects Baseline, 2weeks, 4 weeks and 8 weeks after Blood investigation (complete blood count, liver function test, creatinine, electrolytes),Pain quality Baseline, 2weeks, 4 weeks and 8 weeks after Neuropathic Pain Symptoms Inventory (NPSI)