Nicotinic Acid for Migraine Prevention in Patients on β Blockers
Effect of Nicotinic Acid as add-on Therapy in Patients Receiving β Blocker for Prophylaxis of Moderate to Severe Migraine: A Randomized, Double-blind, Placebo-controlled Trial
This study is testing if adding Nicotinic Acid to the treatment of people with moderate to severe migraines who are already taking β Blockers can help reduce their migraine frequency and intensity.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Academic / other |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT05846373 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Nicotinic Acid as an additional therapy for patients experiencing moderate to severe migraines who are already receiving β Blocker prophylaxis. It is a prospective, single-center, randomized, double-blind, placebo-controlled study that will involve three groups: one receiving 500 mg of Nicotinic Acid, another receiving 1000 mg, and a placebo group. Participants will be monitored over a 12-week period to assess safety and efficacy outcomes based on their migraine frequency and intensity. The study aims to provide insights into the potential benefits of Nicotinic Acid in migraine management.
Who should consider this trial
Good fit: Ideal candidates are individuals aged under 50 with a history of migraine and currently taking β Blockers for prophylaxis.
Not a fit: Patients with certain medical conditions, such as hepatic or psychiatric diseases, or those who are pregnant or lactating, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new adjunctive treatment option for patients struggling with migraine prevention.
How similar studies have performed: While the specific use of Nicotinic Acid in this context is novel, other studies have explored various adjunctive therapies for migraine prevention with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dhaka
- Bsmmu — Dhaka, Bangladesh (Recruiting)
Study contacts
- Study coordinator: Hudia Ta-din, MBBS
- Email: hudiatadin@gmail.com
- Phone: +8801770755901
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.