- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05846373
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
Study Overview
Status
Conditions
Detailed Description
Migraine is "a common episodic neurological disorder with complex pathophysiology that manifests as recurrent attacks of typically throbbing and unilateral, often severe headache with certain associated features such as nausea, phonophobia, and photophobia". Worldwide, estimated prevalence was 13.8% to 15%. Quality of life of a migraine patient is extremely low and migraine badly hampers one's physical, emotional, and social efficiency and disrupt familial, social and professional relationships. Diagnosis is solely clinical depending on characteristics of headache and associated symptoms. Neuroimaging can be done only when exclusion of another cause of headache is needed.
Exact etiology and pathophysiology of migraine is unknown and multifactorial. There are several hypotheses of migraine pain generation. Local dilatation of intracranial and extracerebral vessels activate trigeminal nerve surrounding cerebral and meningeal vasculature. Migraine pain starts from the activation of trigeminovascular system. Afferent fibers innervating cerebral and meningeal vessels project to central nervous system and releases vasoactive peptides and inflammatory mediators. Some important mediators like Calcitonin gene related peptide (CGRP), NO, Substance P play role in inflammation and vasodilatation. Then sensitization and discharge of thalamic neuron and subsequent projection to sensory cortical neurons occurs. Thus, pain perception is received in migraine.
In studies, elevated levels of C reactive protein (CRP) and Transforming growth factor β (TGF-β) provides evidence of neuroinflammation. In migraine, impairment of cerebral mitochondrial energy metabolism and oxidative stress occurs. As a result, abnormalities in cerebral vasculature results in Cortical Spreading Depression (CSD).
Niacin, which is known as nicotinic acid or Vitamin B3 is the precursor of Nicotinamide Adenine Dinucleotide (NAD) or Nicotinamide Adenine Dinucleotide Phosphate (NADP). From dietary tryptophan, through kynurenine pathway, NAD is produced, and rest 1% tryptophan is catabolized to form serotonin (5- hydroxytryptamine/ 5-HT). Migraine is a serotonin deficient condition. It has been estimated that, dietary intake of Niacin is low in migraine patients.
Niacin supplementation provides enough NAD to inhibit Kynurenine pathway and accelerate production of 5-HT from tryptophan. Serotonin acting on 5-HT1 receptor, causes vasoconstriction. It may activate nerve endings in cerebral microcirculation and sensitize them to vasodilatory kinins. Serotonin also inhibits synthesis, release of NO, glutamate, Calcitonin gene-related peptide (CGRP). As a result, inhibition of afferent pain transmission and prevention of neuroinflammation occurs. Niacin also reduces inflammation evidenced by decrease level of pro inflammatory cytokines like IL-6, IL-1β, TNF α, high-sensitivity C-reactive protein (hs-CRP). Increasing level of Niacin also improves brain energy deficiency, and has potent antioxidant properties, which may be helpful in migraine prevention. However, more prospective investigations are necessary to validate niacin's preventive effect on migraine.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Prof. Md. Sayedur Rahman, FCPS, Mphil
- Phone Number: +8801712205305
- Email: srkhasru@bsmmu.edu.bd
Study Contact Backup
- Name: Hudia Ta-din, MBBS
- Phone Number: +8801770755901
- Email: hudiatadin@gmail.com
Study Locations
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Dhaka, Bangladesh, 1000
- Recruiting
- BSMMU
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Contact:
- Registrar
- Phone Number: +88029661064
- Email: hudiatadin@gmail.com
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Principal Investigator:
- Hudia Ta-din, MBBS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nicotinic Acid Extended-release tablet 500 mg arm
This arm includes 22 Migraine patients receiving beta blocker
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Nicotinic acid 500 mg for 12 weeks
Other Names:
|
Active Comparator: Nicotinic Acid Extended-release tablet 1000 mg arm
This arm includes 22 Migraine patients receiving beta blocker
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Nicotinic acid 1000 mg per day for 11 weeks, titrated from 500 mg/day for 1 week
Other Names:
|
Placebo Comparator: Control arm
This arm includes 22 Migraine patients receiving beta blocker
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Placebo 1000 mg per day for 11 weeks, titrated from 500 mg/day for 1 week
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Migraine days/4 weeks
Time Frame: Baseline to week 12
|
Mean change from baseline in migraine days/4 weeks from baseline to weeks 9-12
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Baseline to week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hs-CRP
Time Frame: Baseline to week 12
|
Change in hs-CRP level from baseline to week 12
|
Baseline to week 12
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Visual Analogue Scale (VAS) Score
Time Frame: Baseline to week 12
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Changes of mean VAS Score from baseline to weeks 9 - 12.
The average migraine attack severity will be calculated using the sum of the severity of migraine attacks, divided by the number of qualified migraine attacks.
The scale of severity for each migraine attack ranges from 0 to 10, with higher scores indicating increased migraine severity.
|
Baseline to week 12
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Frequency of use of acute migraine specific medications in the last 4 weeks
Time Frame: Baseline to week 12
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Changes in number of days receiving migraine aborting medication/(s) from baseline to weeks 9-12
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Baseline to week 12
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Migraine Specific Quality of Life questionnaire version 2.1 (MSQ V. 2.1)
Time Frame: Baseline to week 12
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Changes of mean MSQ V. 2.1 score from baseline to weeks 9 -12.
The MSQ V. 2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks.
It is divided into 3 domains; Role function restrictive (RR), Role function preventive (RP), Emotional function (EF) consist of 7, 4 and 3 items respectively.
Score ranges from 0 - 100 in each domain.
The higher scores indicate better outcome.
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Baseline to week 12
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Headache Disorders, Primary
- Headache Disorders
- Migraine Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Antimetabolites
- Micronutrients
- Hypolipidemic Agents
- Lipid Regulating Agents
- Vitamins
- Vitamin B Complex
- Nicotinic Acids
- Niacinamide
- Niacin
Other Study ID Numbers
- BSMMU/2022/11548
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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