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The effects of lacosamide and toptramate combination therapy on chronic migraine

The effects of lacosamide and topiramate versus topiramate and placebo combination therapy on headache in patients with chronic migraine: A randomized double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190804044429N9
Enrollment
74
Registered
2022-09-20
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

Migraine Headache. Migraine

Interventions

Intervention 1: Intervention group: In the first week, all patients will receive lacosamide 100 mg twice a day, and from the second week, they will also receive 150 mg every 12 hours, and in the third

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adults over 18 years old migraine (with or without aura) moderate to high intensity migraine headache (VAS=4)

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Disability improvement. Timepoint: Baseline and third month. Method of measurement: Migraine Disability Assessment.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMonireh Ghazaeian

Mazandaran University of Medical Sciences

ghazaeianm@gmail.com+98 21 8863 6864

Outcome results

None listed

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