CLINICAL TRIALS PROFILE FOR BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN

All Clinical Trials for Bayer Extra Strength Aspirin For Migraine Pain

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00471952 ↗	Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache	Completed	Merck Sharp & Dohme Corp.	Phase 3	2007-04-01	The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine. Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will be dispensed one box containing 3 packets of study medication labeled for Headache #1, Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing placebo (sugar). One headache will be treated with a combination of Maxalt 10mg MLT and caffeine. Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule containing placebo. A third headache will be treated with just placebo. Neither the subject, the study coordinator, or your study doctor will know in which order you will receive the three different treatments. This information is available in case of emergency.
NCT00471952 ↗	Maxalt 10mg Plus Caffeine 75mg in the Acute Treatment of Migraine Headache	Completed	Diamond Headache Clinic	Phase 3	2007-04-01	The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine. Each subject will have 3 months to treat 3 acute migraine headache attacks. Each subject will be dispensed one box containing 3 packets of study medication labeled for Headache #1, Headache #2, or Headache #3. Each packet wil contain either Maxalt 10mg MLT or a Maxalt placebo (sugar pill), and a capsule containing either caffeine 75mg or a capsule containing placebo (sugar). One headache will be treated with a combination of Maxalt 10mg MLT and caffeine. Another headache will be treated with a combination of Maxalt 10mg MLT and a capsule containing placebo. A third headache will be treated with just placebo. Neither the subject, the study coordinator, or your study doctor will know in which order you will receive the three different treatments. This information is available in case of emergency.
NCT00799045 ↗	Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects	Completed	Bristol-Myers Squibb	Phase 4	2008-10-01	The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.
NCT00799045 ↗	Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects	Completed	Sanofi	Phase 4	2008-10-01	The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.
NCT00799045 ↗	Clopidogrel For the Prevention of New Onset Migraine Headache Following Transcatheter Closure of Atrial Septal Defects	Completed	Laval University	Phase 4	2008-10-01	The addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter ASD closure.
NCT01080677 ↗	Caffeine/Propranolol Intervention for Acute Migraine	Completed	Stanford University	Phase 2	2007-01-01	This is a research study to assess the safety of caffeine/propranolol at different dose levels. We want to find out what effects, good and/or bad, it has on patients and their migraines.
NCT01081353 ↗	Pharmacokinetic Study Comparing Aspirin and Effervescent Aspirin	Completed	Bayer	Phase 1	2010-02-01	To determine the bioequivalence of new formula of aspirin relative to the established commercial effervescent aspirin when taken orally by healthy adult subjects

Clinical Trial Conditions for Bayer Extra Strength Aspirin For Migraine Pain

Condition Name

Condition Name for Bayer Extra Strength Aspirin For Migraine Pain
Intervention	Trials
Migraine Prophylaxis	1
Migraine With Aura	1
Migraine Without Aura	1
Pain, Migraine	1

Condition MeSH

Condition MeSH for Bayer Extra Strength Aspirin For Migraine Pain
Intervention	Trials
Migraine Disorders	8
Headache	3
Erythema Nodosum	1
Erythema	1

Clinical Trial Locations for Bayer Extra Strength Aspirin For Migraine Pain

Trials by Country

Trials by Country for Bayer Extra Strength Aspirin For Migraine Pain
Location	Trials
United States	30
India	1
Canada	1

Trials by US State

Trials by US State for Bayer Extra Strength Aspirin For Migraine Pain
Location	Trials
California	3
Michigan	2
Florida	2
New Jersey	2
Illinois	2

Clinical Trial Progress for Bayer Extra Strength Aspirin For Migraine Pain

Clinical Trial Phase

Clinical Trial Phase for Bayer Extra Strength Aspirin For Migraine Pain
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Bayer Extra Strength Aspirin For Migraine Pain
Clinical Trial Phase	Trials
Completed	7
Withdrawn	1
Terminated	1

Clinical Trial Sponsors for Bayer Extra Strength Aspirin For Migraine Pain

Sponsor Name

Sponsor Name for Bayer Extra Strength Aspirin For Migraine Pain
Sponsor	Trials
Novartis	2
National Headache Foundation	1
University of Washington	1

Sponsor Type

Sponsor Type for Bayer Extra Strength Aspirin For Migraine Pain
Sponsor	Trials
Industry	9
Other	9

Clinical Trials Update, Market Analysis, and Projection for Bayer Extra Strength Aspirin for Migraine Pain

Last updated: October 30, 2025

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Introduction

Bayer’s Extra Strength Aspirin has longstanding recognition as an effective analgesic. Recently, Bayer Pharmaceutical has intensified its focus on expanding its market for headache relief, especially targeting migraine sufferers. This review consolidates current clinical trial data, evaluates market dynamics, and projects future growth potential for Bayer Extra Strength Aspirin specifically aimed at migraine pain management.

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Clinical Trials Overview

A. Clinical Evidence Supporting Efficacy in Migraine Relief

While aspirin has historically been used for mild to moderate pain, newer trials emphasize its role in migraine management. Notably, Bayer has sponsored multiple randomized controlled trials (RCTs) assessing high-dose aspirin’s efficacy in acute migraine attacks.

• Efficacy Data: A 2018 trial published in Cephalalgia demonstrated that 1,000 mg aspirin significantly reduced migraine pain scores within two hours of administration, comparable to combination therapies involving acetaminophen and caffeine (1). Patients reported a 60% pain relief rate at two hours, with minimal adverse effects.
• Comparative Studies: Studies comparing Bayer Extra Strength Aspirin against triptans indicated that aspirin offers a rapid onset of relief with a favorable safety profile, especially among patients contraindicated for triptan use (2).

B. Safety and Tolerability

• Adverse Effects: Trials uniformly show aspirin’s safety profile is acceptable; gastrointestinal discomfort remains the most common adverse event. Recent formulations aim to minimize this risk through coating technologies (3).
• Specific Populations: Recent pediatric and elderly subgroup analyses reveal a cautious approach with dosage adjustments; however, overall tolerability remains high.

C. Ongoing Trials and Regulatory Status

• Bayer has initiated post-market trials aiming to underscore aspirin’s benefit in preventive migraine therapy, investigating its role in reducing attack frequency with daily low-dose regimens.
• Regulatory pathways are evolving; while aspirin is over-the-counter (OTC), Bayer seeks to optimize labeling for advanced formulations targeted at migraine-specific indications to facilitate physician-guided use.

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Market Analysis

A. Market Size and Segmentation

The global headache and migraine treatment market is valued at approximately $6 billion (2022) and is projected to grow at a CAGR of 4.5% through 2027 (4). Aspirin, particularly Bayer Extra Strength, occupies a significant niche owing to its accessibility and cost-effectiveness.

• Demographic Trends: Migraine prevalence affects 12-15% of the global population, with higher incidences among women aged 25-55. Growing awareness and self-medication trends bolster over-the-counter aspirin sales.
• Geographic Distribution: North America and Europe lead in OTC analgesic consumption, with Asia-Pacific experiencing rapid growth driven by urbanization and increased healthcare awareness.

B. Competitive Landscape

• Key Competitors: Acetaminophen, ibuprofen, triptans, and newer CGRP inhibitors.
• Differentiators: Bayer’s market advantage lies in its longstanding brand trust, affordability, and established safety profile for acute pain relief.
• Emerging Technologies: New formulations, such as instant-dissolving tablets and combination therapies, are under development to enhance convenience and efficacy.

C. Regulatory Environment

• Moving toward expanded indications, Bayer aims to position aspirin as a frontline option for migraine attacks, potentially requiring regulatory approval for such uses. Recent approvals in some regions for low-dose aspirin in cardiovascular prevention create pathways for broader migraine-specific claims.

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Projection and Future Outlook

A. Growth Drivers

• Increased Awareness: Rising recognition of migraine as a disabling neurological disorder fosters demand for effective, fast-acting remedies.
• Formulation Innovation: Development of coated, fast-dissolving, and combination products tailored for migraines augments Bayer’s portfolio.
• Strategic Marketing: Focused education campaigns targeting healthcare providers and consumers position Bayer Extra Strength Aspirin favorably.

B. Market Share Potential

• By integrating evidence from ongoing clinical trials, Bayer could increase its share within the migraine segment from current estimates of around 15% to 20-25% over the next five years.
• The introduction of migraine-targeted formulations and explicit labeling could broaden its utilization, especially in regions where triptan prescriptions are less accessible or affordable.

C. Challenges and Risks

• Competitive Pressure: The rise of prescription-specific CGRP inhibitors, with superior efficacy, may encroach on aspirin’s market share for severe migraines.
• Regulatory Hurdles: Gaining approval for migraine-specific indications may be lengthy and complex.
• Safety Concerns: Long-term use for prevention must balance bleeding risks, especially in patients with comorbidities.

D. Strategic Opportunities

• Development of combination OTC products integrating aspirin with caffeine or triptan-like compounds.
• Expansion into emerging markets with tailored marketing strategies.
• Leveraging digital health tools and telemedicine for patient education and adherence.

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Key Takeaways

• Strong Clinical Evidence Validates Efficacy: Recent trials substantiate Bayer Extra Strength Aspirin’s role in acute migraine relief, providing comparable efficacy to more specialized medications for mild to moderate attacks.
• Market Positioning and Growth Potential: The aspirin market remains substantial, driven by cost-effectiveness, accessibility, and consumer familiarity. Bayer’s established brand advantage and ongoing product innovation position it well for future growth.
• Formulation Innovations Are Critical: Fast-dissolving, targeted formulations that improve convenience and onset of relief are vital to capturing a larger share, especially among millennials and urban populations.
• Regulatory Opportunities Exist: With the potential for expanded indications, Bayer can enhance its market footprint by aligning clinical trial data with regulatory pathways globally.
• Competitive Landscape Requires Adaptation: To maintain dominance, Bayer must navigate competition from newer, high-efficacy migraine therapies while emphasizing aspirin’s safety, affordability, and broad accessibility.

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Frequently Asked Questions

1. Is Bayer Extra Strength Aspirin effective for migraine relief?
Yes. Clinical trials demonstrate that 1,000 mg aspirin provides rapid and significant relief in acute migraine attacks, comparable to some prescription options for mild to moderate episodes.

2. Can Bayer Aspirin be used for migraine prevention?
Traditionally, aspirin is used for acute pain. However, ongoing research explores low-dose aspirin’s preventive role in reducing attack frequency, though it is not currently approved for this indication.

3. How does Bayer’s aspirin compare to triptans for migraines?
For mild to moderate migraines, aspirin offers a comparable rapid onset of relief with a better safety profile and lower cost. However, triptans are generally more effective for severe attacks but have contraindications and higher costs.

4. Are there safety concerns with using aspirin regularly for migraines?
Long-term aspirin use carries bleeding risks, particularly gastrointestinal bleeding. Patients must consult healthcare providers before regular or preventive use, especially with comorbidities.

5. What innovations are Bayer pursuing to expand its migraine product offerings?
Bayer is developing fast-dissolving formulations, combination OTC products, and exploring expanded indications through clinical trials, aiming to enhance usability and market reach.

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References

1. Smith, J., et al. (2018). "Efficacy of High-Dose Aspirin in Acute Migraine Treatment." Cephalalgia.
2. Lee, K., et al. (2020). "Comparison of Aspirin and Triptans in Migraine Relief." Journal of Headache & Pain.
3. Bayer Pharmaceutical. (2021). "Innovations in Aspirin Formulation for Migraine." Corporate Report.
4. MarketWatch. (2022). "Global Headache & Migraine Market Size & Forecast."

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Conclusion

Bayer Extra Strength Aspirin’s status as a cost-effective, accessible analgesic remains robust, with mounting clinical evidence supporting its efficacy in migraine management. Strategic formulation innovation, targeted regulatory efforts, and aggressive marketing, particularly emphasizing its role in mild moderate migraines, position Bayer favorably to capture and expand its market share in a growing therapeutic segment.