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

NCT05846373 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2025-11-18

No results posted yet for this study

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

Interventions

DRUG

Nicotinic Acid 500 MG Extended Release Oral Tablet

Nicotinic acid 500 mg for 12 weeks

DRUG

Nicotinic Acid 1000 MG Extended Release Oral Tablet

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-25
Primary Completion
2024-01-10
Completion
2024-01-10

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05846373 on ClinicalTrials.gov