Effect of Nicotinic Acid as Add on Therapy in Patients Receiving β Blocker for Prophylaxis of Moderate to Severe Migraine
Migraine Prophylaxis
About this trial
This is an interventional prevention trial for Migraine Prophylaxis
Eligibility Criteria
Inclusion Criteria: Patients suffering from migraine with or without aura according to International ICHD 3 criteria Patients with 4-15 qualified migraine attacks per month during the four weeks of the Baseline Phase History of headache for at least 1 year Age at onset of migraine should be less than 50 years Headache intensity: Moderate to severe (Visual analogue scale score at least 3) Consuming one β Blocker as prophylaxis Exclusion Criteria: Pregnancy and lactation Known case of any hepatic, psychiatric diseases except depression, diabetes mellitus (DM), gout, peptic ulcer disease Known hypersensitivity to niacin Consumption of certain drugs Lipid lowering agents Antiplatelet and Anticoagulants Antihypertensive medications Alcohol or other abusive drugs Plasma Nicotinic acid level > 8.45 ⴗg/ml
Sites / Locations
- BSMMURecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Nicotinic Acid Extended-release tablet 500 mg arm
Nicotinic Acid Extended-release tablet 1000 mg arm
Control arm
During the Titration Phase, Nicotinic acid will be initiated at a dose of 500 mg/day for the first 1 week, continuing into the 11 weeks Maintenance Phase
During the Titration Phase, Nicotinic acid will be initiated at a dose of 500 mg/day for the first 1 week, increased to 1000 mg/day, continuing into the 11 weeks Maintenance Phase
During the Titration Phase, Placebo will be initiated at a dose of 500 mg/day for the first 1 week, increased to 1000 mg/day, continuing into the 11 weeks Maintenance Phase