CLINICAL TRIALS PROFILE FOR MAXALT

All Clinical Trials for Maxalt

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00360282 ↗	Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?	Completed	Merck Sharp & Dohme Corp.	N/A	2006-08-01	The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.
NCT00360282 ↗	Does a Migraine Medication Decrease Rotational Motion Sickness in People Suffering From Migraines?	Completed	University of Pittsburgh	N/A	2006-08-01	The purpose of this study is to determine if Rizatriptan, a migraine medication, lowers motion sickness in migraine sufferers.
NCT00397254 ↗	Two Rizatriptan Prescribing Portions for Treatment of Migraine	Completed	Merck Sharp & Dohme Corp.	Phase 4	2006-12-01	The primary objective of this study is to evaluate a clinical limit (CL) of rizatriptan (9 rizatriptan 10mg Orally Disintegrating Tablet (ODT) per month) versus (vs.) a formulary limit (FL) of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of migraine per month.
NCT00397254 ↗	Two Rizatriptan Prescribing Portions for Treatment of Migraine	Completed	Clinvest	Phase 4	2006-12-01	The primary objective of this study is to evaluate a clinical limit (CL) of rizatriptan (9 rizatriptan 10mg Orally Disintegrating Tablet (ODT) per month) versus (vs.) a formulary limit (FL) of rizatriptan (27 rizatriptan 10mg ODT per month) as measured by the number of days of migraine per month.
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.
NCT00719134 ↗	The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache	Completed	Beth Israel Deaconess Medical Center	Phase 4	2008-09-01	Evidence-based medicine depends on distinguishing between pharmacological effects and placebo effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate fundamental questions concerning pharmacological effects, placebo effects and their interactions. Relief of symptoms of acute migraine will be the test condition for this scientific experiment because of migraine's evident clinical significance and the possibility of using participants as their own control during sequential acute migraine attacks. Our overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an FDA-proven effective medication for acute migraine) and the effects of placebo treatment can be modified by varied knowledge and/or expectation ("contextual") conditions. Such knowledge has the possibility to suggest potentially more efficient methodologies to test new medications that can be used to augment and enhance the apparatus of the RCT. General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo effect, how such effects vary in different knowledge/expectations contexts, and mutually constitute one another and interact. General Hypothesis: The measured pharmacological effect of an effective medication (rizatriptan) and the measured effect of placebo treatment are determined significantly by different knowledge/expectations contexts.

Clinical Trial Conditions for Maxalt

Condition Name

Condition Name for Maxalt
Intervention	Trials
Migraine	3
Migraine With Aura	1
Migraine Without Aura	1
Migraine, Acute	1

Condition MeSH

Condition MeSH for Maxalt
Intervention	Trials
Migraine Disorders	8
Headache	3
Migraine with Aura	1
Motion Sickness	1

Clinical Trial Locations for Maxalt

Trials by Country

Trials by Country for Maxalt
Location	Trials
United States	15

Trials by US State

Trials by US State for Maxalt
Location	Trials
California	2
Pennsylvania	2
New York	1
Minnesota	1
Washington	1

Clinical Trial Progress for Maxalt

Clinical Trial Phase

Clinical Trial Phase for Maxalt
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Maxalt
Clinical Trial Phase	Trials
Completed	8
Withdrawn	1

Clinical Trial Sponsors for Maxalt

Sponsor Name

Sponsor Name for Maxalt
Sponsor	Trials
Merck Sharp & Dohme Corp.	7
Henry M. Jackson Foundation for the Advancement of Military Medicine	1
Robert W. Baloh	1

Sponsor Type

Sponsor Type for Maxalt
Sponsor	Trials
Industry	7
Other	6

Maxalt (Rizatriptan Benzoate): Clinical Trials, Market Analysis, and Projections

Introduction

Maxalt, or rizatriptan benzoate, is a 5-HT1B/1D receptor agonist (triptan) widely used for the acute treatment of migraine headaches. This article delves into the recent clinical trials, market analysis, and future projections for Maxalt.

Clinical Trials Update

Pediatric Indication

In 2011, Merck & Co. submitted a supplemental New Drug Application (sNDA) for Maxalt-MLT to include a new indication for the acute treatment of migraine in pediatric patients. The clinical trial, P082, enrolled two pediatric age groups: 12-17 and 6-11 year olds. The study results showed significant efficacy in both age groups, with pain relief at 2 hours post-treatment being a key endpoint. For the 6-17 year old population, the study demonstrated effective pain relief, although the enrollment for the 6-11 year old group was still ongoing at the time of the sNDA submission[1].

Safety and Adverse Events

The 120-day safety update report for the sNDA revealed no deaths and only a few serious adverse events (SAEs) that were not related to the study drug. Common adverse events associated with triptan use, such as asthenia, dizziness, and nausea, were observed but were generally manageable. The report also noted that liver enzyme abnormalities were transient and normalized upon repeat laboratory assessments[1].

Efficacy in Adults

In adult populations, Maxalt has been extensively studied and proven effective. Clinical trials have shown that Maxalt 5 mg and 10 mg doses significantly reduce headache pain within 2 hours compared to placebo. The efficacy was consistent across various studies, with response rates ranging from 62% to 71% for the 10 mg dose[4].

Market Analysis

Current Market Size and Growth

The global migraine drugs market, which includes Maxalt, has seen robust growth. In 2024, the market size was estimated at $5.38 billion, up from $5 billion in 2023, with a compound annual growth rate (CAGR) of 7.5%. This growth is attributed to advancements in drug formulations, increased awareness and diagnosis of migraines, and the emergence of new treatment options like CGRP inhibitors[2].

Market Projections

By 2028, the migraine drugs market is expected to reach $6.84 billion, with a CAGR of 6.2%. Key factors driving this growth include the adoption of personalized medicine, the increasing use of telemedicine, and the integration of digital therapeutics. The market is also expected to benefit from the development of targeted therapies and the expansion of generic drugs[2].

Long-Term Projections

Looking further ahead to 2033, the migraine therapeutics market in seven major markets (7MM) is projected to grow to $16.4 billion, driven by a CAGR of 6.0%. This growth will be fueled by the continued use of established treatments like triptans and the adoption of newer therapies such as CGRP-targeting monoclonal antibodies (mAbs) and gepants[3].

Market Trends

Personalized Medicine

There is a growing trend towards personalized medicine approaches in migraine treatment. This involves tailoring treatments to individual patient needs, which could further boost the demand for drugs like Maxalt[2].

Telemedicine and Remote Consultations

The increasing use of telemedicine and remote consultations is expected to enhance healthcare delivery for migraine patients, making treatments more accessible and convenient. This trend is likely to support the growth of the migraine drugs market[2].

Digital Therapeutics

The integration of digital therapeutics, such as mobile apps and wearable devices, is becoming more prominent in migraine management. These tools can help in tracking symptoms, managing treatment plans, and providing real-time feedback, which can complement the use of drugs like Maxalt[2].

Combination Therapies

There is an increasing focus on combination therapies that combine different classes of drugs to achieve better outcomes. This could include combining triptans like Maxalt with other migraine treatments to enhance efficacy[2].

Key Benefits and Challenges

Instant Relief

Maxalt is known for providing instant relief from migraine headaches, which is a significant benefit in today's fast-paced world. This quick action can create new opportunities for the market as people seek immediate solutions for their symptoms[5].

Side Effects

Despite its efficacy, Maxalt is associated with side effects such as chest tightness and drowsiness. These adverse effects can hamper the growth of the rizatriptan benzoate market, necessitating careful patient monitoring and management[5].

Conclusion

Maxalt remains a crucial drug in the treatment of migraine headaches, with a strong clinical trial background supporting its efficacy in both adult and pediatric populations. The market for migraine drugs, including Maxalt, is expected to continue growing driven by advancements in treatment options, increased awareness, and the adoption of personalized and digital approaches.

Key Takeaways

• Clinical Efficacy: Maxalt has demonstrated significant efficacy in treating migraine headaches in both adults and pediatric patients.
• Market Growth: The global migraine drugs market is projected to grow from $5.38 billion in 2024 to $6.84 billion by 2028.
• Long-Term Projections: By 2033, the migraine therapeutics market in 7MM is expected to reach $16.4 billion.
• Market Trends: Personalized medicine, telemedicine, digital therapeutics, and combination therapies are key trends driving market growth.
• Challenges: Side effects such as chest tightness and drowsiness need to be managed carefully.

FAQs

What is Maxalt used for?

Maxalt, or rizatriptan benzoate, is used for the acute treatment of migraine headaches in adults and pediatric patients.

What are the common side effects of Maxalt?

Common side effects include asthenia, dizziness, dry mouth, fatigue, somnolence, myalgia, nausea, paresthesia, and throat tightness.

How effective is Maxalt in treating migraines?

Maxalt has been shown to significantly reduce headache pain within 2 hours, with response rates ranging from 62% to 71% for the 10 mg dose.

What is the current market size of the migraine drugs market?

The global migraine drugs market size was estimated at $5.38 billion in 2024.

What are the projected growth rates for the migraine drugs market?

The market is expected to grow at a CAGR of 6.2% from 2024 to 2028 and reach $6.84 billion by 2028.

Sources

1. FDA: sNDA 20,865 (120-Day Safety Update Report), Maxalt-MLT, Merck &Co.[1]
2. GlobeNewswire: Global Migraine Drugs Market Report 2024[2]
3. GlobeNewswire: 7MM Migraine Drug Market Forecast and Analysis to 2033[3]
4. FDA: MAXALT (Rizatriptan Benzoate) Tablets and MAXALT-MLT (Rizatriptan Benzoate) Orally Disintegrating Tablets[4]
5. Allied Market Research: Rizatriptan Benzoate Market Statistics | Forecast 2030[5]

Last updated: 2024-12-31