acosamide efficasy and safety on pain in patients with multiple sclerosis: A randomized double_blind clinical trial

Phase 3

Recruiting

Conditions: Pain caused by MS.
Multiple sclerosis

Registration Number: IRCT20190804044429N8

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 56

Inclusion Criteria

Adults over the age of 18 and suffering from MS with moderate to high MS pain complaint

Exclusion Criteria

Severe depression or suicidal thoughts
Thyroid disorders
Severe anemia (Hb<9g/dl)
Breast feeding or pregnancy
History of cerebral ischemia or cardiovascular disease
Having kidney failure (creatinine clearance less than 30 ml/min)
Existence of an MS attack during the past month
Concomitant use of drugs effective in pain control during the last month
History of abuse of drugs, psychotropic substances and alcohol
History of liver failure
History of cardiac arrhythmia or simultaneous use of drugs affecting heart rhythm
Failure to receive corticosteroid pulse within a month before the starting of study
Absence of a history of structural disorder affecting the occurrence of pain such as discopathy and other disease affecting the occurrence of neuropathic pain( diabetes, trigeminal neuralgia,...)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intensity of pain caused by MS. Timepoint: Weeks 0-4-8-12. Method of measurement: Brief pain index (BPI).;Intensity of pain caused by MS. Timepoint: Weeks 0-4-8-12. Method of measurement: NPSI (Neuropathic Pain Symptom Inventory ).;The overall improvement rate of MS patients after taking lacosamide. Timepoint: Weeks 0-4-8-12. Method of measurement: Patient Global Impression of Change (PGIC).;The safety of lacosamide in improving pain caused by MS. Timepoint: Weekly. Method of measurement: Patient tolerability.

Secondary Outcome Measures

Name	Time	Method
Determining the improvement in function and quality of life of patients with MS following the use of lacosamide. Timepoint: Weeks 0-8-12. Method of measurement: Item Short Form Survey (SF-36).