The effects of lacosamide and toptramate combination therapy on chronic migraine
Phase 3
Recruiting
- Conditions
- Migraine Headache.Migraine
- Registration Number
- IRCT20190804044429N9
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 74
Inclusion Criteria
Adults over 18 years old
migraine (with or without aura)
moderate to high intensity migraine headache (VAS=4)
Exclusion Criteria
Severe depression or suicidal thoughts
Thyroid disorders
Pregnancy
Lactation
History of ischemic cerebral disease or ischemic heart disease
Renal dysfunction (GFR less than 30 ml/min)
medication overuse headache
History of drug abuse and alcohol
History of hepatic failure
A history of cardiac arrhythmia or using drugs that affect heart rhythm
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of days that the individual has experienced headache. Timepoint: At the beginning of the study, in the 8th week (56 days after baseline) and in the 11th week (84 days after baseline). Method of measurement: History taking.;The number of headache attacks. Timepoint: weekly, up to 12 weeks. Method of measurement: Visual analogue scale (VAS).
- Secondary Outcome Measures
Name Time Method Disability improvement. Timepoint: Baseline and third month. Method of measurement: Migraine Disability Assessment.