A Phase 4 interventional study of Valproic Acid 500 MG and Propranolol in Migraine Disorders, sponsored by Kafrelsheikh University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Kafrelsheikh University · Phase 4, Interventional, and Treatment
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.
Investigators will enrol 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 500-1000 mg valproate 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. 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.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's planned enrollment of 600 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Naive migraine patients, according to the International Classification of Headache Disorders 3rd edition, aged 18-75 years,
Exclusion Criteria:
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive valproate 500-1000 mg daily for three months. 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. Treatment safety was evaluated by monitoring and documenting patients' treatment-emergent adverse events (TEAE) through regular follow-up procedures for three months.
Drug: Valproic Acid 500 MG
The arm will include 300 migraine patients diagnosed according to ICHD3-beta criteria. All patients will receive propranolol 160 mg once daily for 3 months. 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.
Drug: Propranolol
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 treatment safety was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
Also known as: group A
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 treatment safety was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
Also known as: group B
The change in migraine days per 28 days
The investigators will assess the change in migraine days per 28 days in each group.
Time frame: 28 days
The total number of migraine days after three months of treatment
The investigators will assess the total migraine days after three months of regular use of 500-1000 mg valproate daily or propranolol (160 mg once daily).
Time frame: 3 months
The percentage of patients who achieved ≥ 50% change in the monthly migraine days frequency compared to the baseline frequency.
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
Time frame: 3 months
HIT-6 score absolute change in each group after three months of treatment
The investigators assessed the absolute change in HIT6 score; the Headache Impact Test-6 (HIT-6) evaluated 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 more significant impact of headaches 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)
Time frame: 3 months
Incidence of Treatment-Emergent Adverse Events
The safety of treatment was evaluated by monitoring and documenting treatment-emergent adverse events (TEAE) in patients through regular follow-up procedures for three months.
Time frame: 3 months
Plan to share: No — The principal investigator, Mohamed G. Zeinhom, may provide all the data supporting this research's findings upon reasonable request.
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Kafrelsheikh University