Lacosamide Versus Propranolol in Migraine
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigators aim to compare the effect of lacosamide versus propranolol 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.
    

Detailed description: 
      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 propranolol 160 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.
    

Intervention name(s): Lacosamide tablet; Propranolol
Intervention type(s): Drug; Drug
Intervention description(s): The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess The change in migraine days per 28 days, 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.; The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. We will assess The change in migraine days per 28 days, 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.
Intervention MeSH terms: Propranolol; Lacosamide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We 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.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lacosamide; migraine; Propranolol