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

NCT05846373 | Completed Phase 2

• 1 other identifier: BSMMU/2022/11548
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Migraine days/4 weeks

  Mean change from baseline in migraine days/4 weeks from baseline to weeks 9-12

  Baseline to week 12

Secondary Outcomes (4)

• Visual Analogue Scale (VAS) Score

  Baseline to week 12

• Migraine Specific Quality of Life questionnaire version 2.1 (MSQ V. 2.1)

  Baseline to week 12

• Frequency of use of acute migraine specific medications in the last 4 weeks

  Baseline to week 12

• hs-CRP

  Baseline to week 12

Study Arms (3)

Nicotinic Acid Extended-release tablet 500 mg arm

ACTIVE COMPARATOR

This arm includes 22 Migraine patients receiving beta blocker

Drug: Nicotinic Acid 500 MG Extended Release Oral Tablet

Nicotinic Acid Extended-release tablet 1000 mg arm

ACTIVE COMPARATOR

This arm includes 22 Migraine patients receiving beta blocker

Drug: Nicotinic Acid 1000 MG Extended Release Oral Tablet

Control arm

PLACEBO COMPARATOR

This arm includes 22 Migraine patients receiving beta blocker

Other: Placebo

Interventions

Nicotinic Acid 500 MG Extended Release Oral Tablet DRUG

Nicotinic acid 500 mg for 12 weeks

Also known as: Niacin

Nicotinic Acid Extended-release tablet 500 mg arm

Nicotinic Acid 1000 MG Extended Release Oral Tablet DRUG

Nicotinic acid 1000 mg per day for 11 weeks, titrated from 500 mg/day for 1 week

Also known as: Niacin

Nicotinic Acid Extended-release tablet 1000 mg arm

Placebo OTHER

Placebo 1000 mg per day for 11 weeks, titrated from 500 mg/day for 1 week

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 µg/mL

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Interventions

Niacin

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 6, 2023
• Study Start: November 25, 2022
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: November 18, 2025

Record last verified: 2024-01

Locations

BA (1)