Clinical trial NCT05851781: Lacosamide Versus Propranolol in Migraine
Official title: Safety and Efficacy of Lacosamide Versus Propranolol in Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine Disorders
Keywords: lacosamide
migraine
Propranolol
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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 the second group will receive propranolol 160 mg per day. 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.

Eligibility criteria: Inclusion Criteria:

* Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 18-75 years,

Exclusion Criteria:

* Patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors.
* patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases.
* patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/Hg on at least three different occasions, diabetes (fasting plasma glucose level \>126 mg/dl and/or a casual plasma glucose \>200 mg/dl and/or HbA1C more than 6.5.
* patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure
* patients who received prophylactic treatment for migraine,
* patients with any contraindications to drugs used in the study
* patients with bronchial asthma, chronic obstructive pulmonary disease

Primary outcomes:
measure: The change in migraine days per 28 days
timeFrame: 28 days
Secondary outcomes:
measure: The total number of migraine days after three months of treatment
timeFrame: 3 months
measure: The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency.
timeFrame: 3 months
measure: HIT-6 score absolute reduction in each group after three months of treatment
timeFrame: 3 months
measure: The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months.
timeFrame: 3 months
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr Elsheikh University Hospital
Study officials:
affiliation: neurology department kafr el-sheikh university
name: mohamed G. Zeinhom, MD
role: STUDY_DIRECTOR
affiliation: neurology department kafr el-sheikh university
name: sherihan R. Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mushet GR, Miller D, Clements B, Pait G, Gutterman DL. Impact of sumatriptan on workplace productivity, nonwork activities, and health-related quality of life among hospital employees with migraine. Headache. 1996 Mar;36(3):137-43. doi: 10.1046/j.1526-4610.1996.3603137.x.
citation: Lipton RB, Scher AI, Kolodner K, Liberman J, Steiner TJ, Stewart WF. Migraine in the United States: epidemiology and patterns of health care use. Neurology. 2002 Mar 26;58(6):885-94. doi: 10.1212/wnl.58.6.885.
citation: Lipton RB, Liberman JN, Kolodner KB, Bigal ME, Dowson A, Stewart WF. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia. 2003 Jul;23(6):441-50. doi: 10.1046/j.1468-2982.2003.00546.x.