Image

Zonisamide Versus Propranolol in Migraine

Zonisamide Versus Propranolol in Migraine

Recruiting
10-55 years
All
Phase 3

Powered by AI

Overview

Investigators aim to compare the effect of zonisamide 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

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 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. 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

Inclusion Criteria:

  • Naive 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 malignancy, collagen, liver, and renal diseases. patients with cardiovascular
        diseases like hypertension and diabetes 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

Study details
    Migraine

NCT06361446

Kafrelsheikh University

1 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.