Migraine
Conditions
Keywords
zonisamide, topiramate, migraine
Brief summary
Investigators aim to compare the effect of zonisamide 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
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 100mg zonisamide 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. 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.
Interventions
DRUGZonisamide 50 MG
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 zonisamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
DRUGTopiramate 50 MG
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 topiramate was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
An independent statistician generated a blocked randomization sequence using computer-generated random numbers; participants received either zonisamide and acetaminophen or topiramate and acetaminophen 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 enrollment numbers starting from 1, which were mentioned in 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 zonisamide and acetaminophen, and Drug B included topiramate and acetaminophen. The statistical analysis was performed by an independent statistician who did not know the treatment protocol of groups A or B
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. 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
Sex/Gender
ALL
Age
10 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* migraine patients, according to the International Classification of Headache Disorders 3rd edition, * age from 10 to 55 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, such as 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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in migraine days per 28 days | 28 days | The investigators will assess the change in migraine days per 28 days in each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The total number of migraine days after three months of treatment | 3 months | The investigators will assess the total migraine days after three months of regular use of 100 mg zonisamide twice daily and Acetaminophen 500-1000 mg in acute attack or topiramate (100 mg once daily) and Acetaminophen 500-1000 mg in acute attack alone. |
| The percentage of patients who achieved ≥ 50% reduction in the monthly migraine days frequency compared to the baseline frequency. | 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 |
| HIT-6 score absolute reduction in each group after three months of treatment | 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) |
| The safety of lacosamide was evaluated by monitoring treatment-emergent adverse events (TEAE) for three months. | 3 months | The safety of zonisamide was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months. |
Countries
Egypt
Outcome results
None listed