Comparing valproate and propranolol for migraine treatment
Valproate Versus Propranolol in Migraine, a Randomized Controlled Trial
PHASE4 · Kafrelsheikh University · NCT06485726
This study is testing whether valproate or propranolol is better at reducing the number of migraine days for people who suffer from migraines.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University (other) |
| Locations | 1 site (Kafr ash Shaykh) |
| Trial ID | NCT06485726 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of valproate and propranolol in reducing the frequency of migraine days in patients diagnosed with migraine disorders. A total of 600 participants will be enrolled and divided into two groups, with one group receiving valproate and the other receiving propranolol for three months. The primary outcomes will include the absolute reduction in monthly migraine days and the percentage of patients achieving a 50% or greater reduction in headache frequency. Safety will be monitored through regular follow-ups to document any treatment-emergent adverse events.
Who should consider this trial
Good fit: Ideal candidates are naive migraine patients aged 18-75 who meet the ICHD3-beta criteria.
Not a fit: Patients with major neurological or systemic diseases, cardiovascular conditions, or those who have previously received prophylactic migraine treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into more effective treatment options for migraine patients.
How similar studies have performed: Previous studies have shown varying success with both valproate and propranolol in migraine treatment, but this specific comparative approach is less common.
Eligibility criteria
Show full inclusion / exclusion 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 tumours, 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
Where this trial is running
Kafr ash Shaykh
- Kafr Elsheikh University Hospital — Kafr ash Shaykh, Egypt (RECRUITING)
Study contacts
- Study coordinator: mohamed G. Zeinhom, MD
- Email: mohamed_gomaa@med.kfs.edu.eg
- Phone: 2001009606828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Migraine Disorders, propranolol, valproate, migraine