Kafrelsheikh University
Mohamed G. zeinhom, MD
Investigators aim to compare the effect of lacosamide versus topiramate in migraine by assessing the absolute reduction in MMD in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.
Migraine Disorders
Lacosamide 50 MG
Topiramate 50Mg Tab
PHASE3
Investigators will enroll 600 migraine patients who are diagnosed according to ICHD3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 50 mg lacosamide twice daily and Acetaminophen 500-1000 mg in acute attack, and the second group will receive topiramate100 mg per day and Acetaminophen 500-1000 mg in acute attack for at least three months. Investigators will assess The number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency (14).. HIT-6 score reduction in each group after three months of treatment. The safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 600 participants |
| Masking : | DOUBLE |
| Masking Description : | An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either lacosamide or topiramate from a specially trained and qualified nurse. We prepared Sequentially numbered opaque sealed envelopes and 600 labels for each drug labeled Drug A or B. According to the randomization chart, put them into envelopes numbered 1 to 600. Envelopes were attached to the patient's files. Patients were recruited sequentially and were given enrolment numbers starting from 1, which were mentioned on their files. Files with the same number as the patient enrolment number were opened and the patients were assigned to receive drugs A or B. Drug A included lacosamide, and Drug B included propranolol. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B. Both groups received open-label 500-1000mg acetaminophen during acute attack. |
| Primary Purpose : | TREATMENT |
| Official Title : | Lacosamide Versus Topiramate in Migraine, a Ranodmized Trial |
| Actual Study Start Date : | 2024-02-01 |
| Estimated Primary Completion Date : | 2025-02-02 |
| Estimated Study Completion Date : | 2025-02-25 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 10 Years to 55 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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RECRUITING
Kafr Elsheikh University Hospital
Kafr Ash Shaikh, Egypt, 33511