No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
600 (estimated)
Sponsor
Kafrelsheikh University · Other
Who this trial is looking for
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Investigators aim to compare the effect of valproate versus propranolol in migraine by assessing the absolute reduction in MMD in each group and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.
Trial Locations
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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 dis…
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
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