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NCT Number: NCT05851781

Lacosamide Versus Propranolol in Migraine

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.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kafr Elsheikh University Hospital

Kafr ash Shaykh, 33511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacosamide tablet

Drug

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.

Propranolol

Drug

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.

Primary outcomes

  1. The change in migraine days per 28 days

    Time frame: 28 days

    The investigators will assess the change in migraine days per 28 days in each group.

Secondary outcomes

  1. The total number of migraine days after three months of treatment

    Time frame: 3 months

    The investigators will assess the total migraine days after three months of regular use of 50 mg lacosamide twice daily and or propranolol (160 mg once daily).

  2. The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency.

    Time frame: 3 months

    We will assess The percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency in each group

  3. HIT-6 score absolute reduction in each group after three months of treatment

    Time frame: 3 months

    The investigators assessed the absolute reduction in HIT6 score, the Headache Impact Test-6 (HIT-6) assessed the burden of headache in each group; the HIT-6 consists of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress, the patient answers each of the six related questions using one of the following five responses: "never", "rarely", "sometimes", "very often," or "always." These responses are summed to produce a total HIT-6 score that ranges from 36 to 78, where a higher score indicates a greater impact of headache on the daily life of the respondent. It has four impact grades: little-to-no impact (HIT-6 score: 36-49), moderate impact (HIT-6 score: 50-55), substantial impact (HIT-6 score: 56-59), and severe impact (HIT-6 score: 60-78)

  4. The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months.

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Safety and Efficacy of Lacosamide Versus Propranolol in Migraine

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 10, 2023
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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