CLINICAL TRIALS PROFILE FOR MAXALT-MLT

All Clinical Trials for MAXALT-MLT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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.
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.

Clinical Trial Conditions for MAXALT-MLT

Condition Name

Condition Name for MAXALT-MLT
Intervention	Trials
Migraine	3
Migraine With Aura	1
Migraine Without Aura	1
Migraine, Acute	1

Condition MeSH

Condition MeSH for MAXALT-MLT
Intervention	Trials
Migraine Disorders	8
Headache	3
Migraine without Aura	1
Migraine with Aura	1

Clinical Trial Locations for MAXALT-MLT

Trials by Country

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−

Trials by Country for MAXALT-MLT
Location	Trials
United States	15

Trials by US State

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−

Trials by US State for MAXALT-MLT
Location	Trials
California	2
Pennsylvania	2
Georgia	1
Florida	1
New York	1

Clinical Trial Progress for MAXALT-MLT

Clinical Trial Phase

Clinical Trial Phase for MAXALT-MLT
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for MAXALT-MLT
Clinical Trial Phase	Trials
Completed	8
Withdrawn	1

Clinical Trial Sponsors for MAXALT-MLT

Sponsor Name

Sponsor Name for MAXALT-MLT
Sponsor	Trials
Merck Sharp & Dohme Corp.	7
Diamond Headache Clinic	1
Beth Israel Deaconess Medical Center	1

Sponsor Type

Sponsor Type for MAXALT-MLT
Sponsor	Trials
Industry	7
Other	6

Maxalt-MLT: Clinical Trials, Market Analysis, and Projections

Introduction to Maxalt-MLT

Maxalt-MLT, or rizatriptan benzoate, is a medication specifically designed for the acute treatment of migraine attacks with or without aura in adults. It is available in orally disintegrating tablets, making it a convenient option for those suffering from migraines.

Clinical Trials Overview

Adult Studies

The efficacy of Maxalt-MLT was established through two multicenter, randomized, placebo-controlled trials (Studies 5 and 6). These studies involved primarily female (88%) and Caucasian (95%) patients, with a mean age of 42 years (range 18-72)[1][4].

• Study 5 and 6 Results:
  • In both studies, a significantly greater percentage of patients treated with Maxalt-MLT 5 mg or 10 mg achieved headache response 2 hours after treatment compared to those who received placebo.
  • Specifically, Study 5 showed that 66% of patients on Maxalt-MLT 5 mg and 66% on Maxalt-MLT 10 mg achieved headache response, compared to 47% on placebo.
  • Study 6 reported that 59% of patients on Maxalt-MLT 5 mg and 74% on Maxalt-MLT 10 mg achieved headache response, compared to 28% on placebo[1][4].

Pediatric Studies

A multicenter, randomized, double-blind, placebo-controlled trial (Study 7) evaluated the efficacy of Maxalt-MLT in pediatric patients aged 6 to 17 years. Patients were required to have a history of migraine attacks lasting at least 3 hours when untreated and were non-responsive to NSAIDs and acetaminophen.

• Study 7 Results:
  • Patients weighing between 20 kg to <40 kg received Maxalt-MLT 5 mg or placebo, while those weighing ≥40 kg received Maxalt-MLT 10 mg or placebo.
  • The results showed that a significantly greater percentage of patients who received Maxalt-MLT achieved no headache pain at 2 hours after treatment compared to those who received placebo (33% vs. 24%)[1].

Market Analysis

Global Migraine Therapeutics Market

The global migraine therapeutics market is projected to grow significantly over the coming years.

• Market Size and Growth:
  • The market is expected to reach USD 6.58 billion in 2025 and grow at a CAGR of 6.84% to reach USD 9.16 billion by 2030[2].
• Regional Dominance:
  • North America is expected to dominate the market, driven by the high prevalence of migraines and the increasing adoption of novel therapeutics. For instance, in the United States, 17.1% of women and 5.6% of men reported having migraine symptoms[2].

Triptans Segment

Maxalt-MLT, being a triptan, is part of a segment that is expected to see significant growth.

• Efficacy and Safety:
  • Triptans, such as Maxalt-MLT, have been shown to have higher efficacy compared to newer agents like ditans and gepants. However, they are associated with more adverse events[2].
• Market Drivers:
  • The launch of new products in the triptan class, such as REYVOW (lasmiditan) by Eli Lilly and Company, is driving the growth of this segment[2].

Rizatriptan Benzoate Market

The rizatriptan benzoate market, specifically, is influenced by several factors.

• Growth Drivers:
  • The rise in pressure on daily life leading to anxiety and headaches, and the increasing incidence of migraines in children and adults, are key drivers of the market[5].
• Challenges:
  • Side effects such as tightness in the chest and drowsiness are expected to hamper the growth of the rizatriptan benzoate market[5].

Market Projections

Future Outlook

The market for Maxalt-MLT and other triptans is expected to remain robust due to several factors.

• New Product Launches:
  • The launch of generic versions, such as the one by Teva Generics in 2020, is expected to flourish the market by providing more affordable options[5].
• Increasing Demand:
  • The need for instant relief from migraines in a fast-paced world creates new opportunities for the rizatriptan benzoate market[5].

Regional Growth

• Asia Pacific:
  • This region is estimated to grow at the highest CAGR over the forecast period (2025-2030), driven by increasing healthcare spending and awareness about migraine treatments[2].

Key Benefits and Challenges

Benefits

• Efficacy:
  • Maxalt-MLT has been shown to be highly effective in treating migraine attacks, with a significant percentage of patients achieving headache response within 2 hours[1][4].
• Convenience:
  • The orally disintegrating tablets offer a convenient and quick way to administer the medication, which is particularly beneficial for those experiencing sudden migraine attacks[1].

Challenges

• Side Effects:
  • Common side effects include tightness in the chest and drowsiness, which can hamper the growth of the market[5].
• Drug Interactions:
  • Maxalt-MLT can interact with certain medications, such as MAO inhibitors, which can significantly increase the levels of rizatriptan in the body[4].

Conclusion

Maxalt-MLT is a highly effective medication for the acute treatment of migraines, supported by robust clinical trial data. The market for this and other triptans is expected to grow significantly, driven by increasing demand and new product launches. However, it is important to consider the potential side effects and drug interactions when prescribing or using Maxalt-MLT.

Key Takeaways

• Clinical Efficacy: Maxalt-MLT has shown significant efficacy in treating migraines in both adult and pediatric populations.
• Market Growth: The global migraine therapeutics market, particularly the triptans segment, is expected to grow at a CAGR of 6.84% from 2025 to 2030.
• Regional Dominance: North America is expected to dominate the market, with Asia Pacific being the fastest-growing region.
• Challenges: Side effects and drug interactions are key challenges that need to be addressed.

FAQs

What is the primary use of Maxalt-MLT?

Maxalt-MLT is used for the acute treatment of migraine attacks with or without aura in adults.

How effective is Maxalt-MLT in treating migraines?

Clinical trials have shown that Maxalt-MLT is highly effective, with a significant percentage of patients achieving headache response within 2 hours of treatment.

What are the common side effects of Maxalt-MLT?

Common side effects include tightness in the chest and drowsiness.

Can Maxalt-MLT interact with other medications?

Yes, Maxalt-MLT can interact with certain medications, such as MAO inhibitors, which can significantly increase the levels of rizatriptan in the body.

What is the projected market size for the global migraine therapeutics market by 2030?

The global migraine therapeutics market is expected to reach USD 9.16 billion by 2030, growing at a CAGR of 6.84% from 2025 to 2030.

Sources

1. eMPR.com: MAXALT-MLT Prescription & Dosage Information.
2. Mordor Intelligence: Migraine Therapeutics Market Size & Share Analysis.
3. PR Newswire: World Migraine Therapeutics Market Study 2019-2024 - Triptans Projected to Grow at a Healthy CAGR.
4. FDA: MAXALT (Rizatriptan Benzoate) Tablets MAXALT-MLT (Rizatriptan Benzoate) Orally Disintegrating Tablets.
5. Allied Market Research: Rizatriptan Benzoate Market Statistics | Forecast 2030.