NCT05846373CompletedPhase 2
Effect of Nicotinic Acid as Add on Therapy in Patients Receiving β Blocker for Prophylaxis of Moderate to Severe Migraine
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
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
This is a prospective single center, randomized, double-blind, 3 arm placebo-controlled study in subjects with migraine headache requiring prophylactic treatment. The patients will be randomized to receive Nicotinic Acid Extended-release tablet 500 mg or 1000 mg or placebo for 12 weeks. The safety and efficacy outcome measures will be assessed at baseline and 12 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 26 Apr 2023
- Start date
- 25 Nov 2022
- Primary completion date
- 10 Jan 2024
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Diseases
- Migraine
- NCT number
- NCT05846373
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 58
- From 25 Nov 2022 to the primary completion date, 10 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Consumption of certain drugs Lipid lowering agents Antiplatelet and Anticoagulants Antihypertensive medications Alcohol or other abusive drugs
Other illness
- Known case of any hepatic, psychiatric diseases except depression, diabetes mellitus (DM), gout, peptic ulcer disease
- Known hypersensitivity to niacin
Other
- Pregnancy and lactation
- Plasma Nicotinic acid level \> 8.45 µg/mL
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BSMMU Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.