Effect of Nicotinic Acid as Add on Therapy in Patients Receiving β Blocker for Prophylaxis of Moderate to Severe Migraine

Launched by BANGABANDHU SHEIKH MUJIB MEDICAL UNIVERSITY, DHAKA, BANGLADESH · Apr 26, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Nicotinic Acid, also known as niacin, as an additional treatment for people who experience moderate to severe migraines and are already taking a β Blocker to help prevent their headaches. The trial will involve patients who have had migraines for at least a year and experience 4 to 15 migraine attacks each month. Participants must be between the ages of 18 and 75 and should have their migraines starting before age 50.

During the trial, participants will be randomly assigned to take either a 500 mg or a 1000 mg Nicotinic Acid tablet or a placebo (a pill that looks like the medication but has no active ingredients) for 12 weeks. The researchers will check how well the treatment works and if it is safe by comparing the results at the start and after 12 weeks. It’s important to note that certain people, such as those who are pregnant, have specific medical conditions, or are taking certain medications, may not be eligible to participate. If you or someone you know experiences frequent migraines, this trial might be a potential option to explore.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients suffering from migraine with or without aura according to International ICHD 3 criteria
• • 2. Patients with 4-15 qualified migraine attacks per month during the four weeks of the Baseline Phase
• • 3. History of headache for at least 1 year
• • 4. Age at onset of migraine should be less than 50 years
• • 5. Headache intensity: Moderate to severe (Visual analogue scale score at least 3)
• • 6. Consuming one β Blocker as prophylaxis
• Exclusion Criteria:
• • 1. Pregnancy and lactation
• • 2. Known case of any hepatic, psychiatric diseases except depression, diabetes mellitus (DM), gout, peptic ulcer disease
• • 3. Known hypersensitivity to niacin
• • 4. Consumption of certain drugs Lipid lowering agents Antiplatelet and Anticoagulants Antihypertensive medications Alcohol or other abusive drugs
• • 5. Plasma Nicotinic acid level \> 8.45 µg/mL