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

Primary Purpose

Migraine Prophylaxis

Status
Recruiting
Phase
Phase 2
Locations
Bangladesh
Study Type
Interventional
Intervention
Nicotinic Acid 500 MG Extended Release Oral Tablet
Nicotinic Acid 1000 MG Extended Release Oral Tablet
Placebo
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine Prophylaxis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ⴗg/ml

Sites / Locations

  • BSMMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Nicotinic Acid Extended-release tablet 500 mg arm

Nicotinic Acid Extended-release tablet 1000 mg arm

Control arm

Arm Description

During the Titration Phase, Nicotinic acid will be initiated at a dose of 500 mg/day for the first 1 week, continuing into the 11 weeks Maintenance Phase

During the Titration Phase, Nicotinic acid will be initiated at a dose of 500 mg/day for the first 1 week, increased to 1000 mg/day, continuing into the 11 weeks Maintenance Phase

During the Titration Phase, Placebo will be initiated at a dose of 500 mg/day for the first 1 week, increased to 1000 mg/day, continuing into the 11 weeks Maintenance Phase

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analogue Scale (VAS) Score
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.
Migraine Specific Quality of Life questionnaire version 2.1 (MSQ V. 2.1)
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 20 - 120 in each domain. The higher scores indicate better outcome.
Frequency of use of acute migraine specific medications in the last 4 weeks
Changes in number of days receiving migraine aborting medication/(s) from baseline to weeks 9-12
hs-CRP
Change in hs-CRP level from baseline to week 12

Full Information

First Posted
April 26, 2023
Last Updated
May 5, 2023
Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT05846373
Brief Title
Effect of Nicotinic Acid as Add on Therapy in Patients Receiving β Blocker for Prophylaxis of Moderate to Severe Migraine
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
January 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nicotinic Acid Extended-release tablet 500 mg arm
Arm Type
Active Comparator
Arm Description
During the Titration Phase, Nicotinic acid will be initiated at a dose of 500 mg/day for the first 1 week, continuing into the 11 weeks Maintenance Phase
Arm Title
Nicotinic Acid Extended-release tablet 1000 mg arm
Arm Type
Active Comparator
Arm Description
During the Titration Phase, Nicotinic acid will be initiated at a dose of 500 mg/day for the first 1 week, increased to 1000 mg/day, continuing into the 11 weeks Maintenance Phase
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
During the Titration Phase, Placebo will be initiated at a dose of 500 mg/day for the first 1 week, increased to 1000 mg/day, continuing into the 11 weeks Maintenance Phase
Intervention Type
Drug
Intervention Name(s)
Nicotinic Acid 500 MG Extended Release Oral Tablet
Other Intervention Name(s)
Niacin
Intervention Description
Nicotinic acid 500 mg at bedtime
Intervention Type
Drug
Intervention Name(s)
Nicotinic Acid 1000 MG Extended Release Oral Tablet
Other Intervention Name(s)
Niacin
Intervention Description
Nicotinic acid 1000 mg at bedtime
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo 1000 mg at bedtime
Primary Outcome Measure Information:
Title
Migraine days/4 weeks
Description
Mean change from baseline in migraine days/4 weeks from baseline to weeks 9-12
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) Score
Description
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.
Time Frame
Baseline to week 12
Title
Migraine Specific Quality of Life questionnaire version 2.1 (MSQ V. 2.1)
Description
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 20 - 120 in each domain. The higher scores indicate better outcome.
Time Frame
Baseline to week 12
Title
Frequency of use of acute migraine specific medications in the last 4 weeks
Description
Changes in number of days receiving migraine aborting medication/(s) from baseline to weeks 9-12
Time Frame
Baseline to week 12
Title
hs-CRP
Description
Change in hs-CRP level from baseline to week 12
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ⴗg/ml
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hudia Ta-din, MBBS
Phone
+8801770755901
Email
hudiatadin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Md. Sayedur Rahman, FCPS, Mphil
Phone
+8801712205305
Email
srkhasru@bsmmu.edu.bd
Facility Information:
Facility Name
BSMMU
City
Dhaka
ZIP/Postal Code
1000
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Registrar
Phone
+88029661064
Email
hudiatadin@gmail.com
First Name & Middle Initial & Last Name & Degree
Hudia Ta-din, MBBS

12. IPD Sharing Statement

Learn more about this trial

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

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