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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190804044429N8
Enrollment
56
Registered
2022-09-04
Start date
2022-09-23
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Pain caused by MS. Multiple sclerosis

Interventions

Intervention 1: Intervention group: Half of the patients in the lacosamide group received lacosamide tablets 100 mg twice a day in the first week, and from the second week, the dose was prescribed as

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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,...)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Ghazaeian

Mazandaran University of Medical Sciences

Ghazaeianm@gmail.com+98 33343011

Outcome results

None listed

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