CLINICAL TRIALS PROFILE FOR MAXALT-MLT

All Clinical Trials for MAXALT-MLT

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.

Clinical Trial Conditions for MAXALT-MLT

Condition Name

Condition Name for MAXALT-MLT
Intervention	Trials
Migraine	4
Migraine, Acute	1
Migrainous Vertigo	1
Vestibular Migraine	1

Condition MeSH

Condition MeSH for MAXALT-MLT
Intervention	Trials
Migraine Disorders	9
Headache	4
Vertigo	1
Tension-Type Headache	1

Clinical Trial Locations for MAXALT-MLT

Trials by Country

Trials by Country for MAXALT-MLT
Location	Trials
United States	16

Trials by US State

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

Clinical Trial Progress for MAXALT-MLT

Clinical Trial Phase

Clinical Trial Phase for MAXALT-MLT
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	2
Phase 3	4

Clinical Trial Status

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Withdrawn	1

Clinical Trial Sponsors for MAXALT-MLT

Sponsor Name

Sponsor Name for MAXALT-MLT
Sponsor	Trials
Merck Sharp & Dohme Corp.	7
University of Pittsburgh	1
Clinvest	1

Sponsor Type

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

Maxalt-mlt: Clinical Trials Update, Market Analysis, and Projection

Last updated: February 20, 2026

What is Maxalt-mlt?

Maxalt-mlt (rizatriptan benzoate with naproxen sodium) is a combination medication approved for acute treatment of migraine with or without aura. This drug combines rizatriptan, a serotonin receptor agonist, with naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID). It aims to provide rapid relief with reduced recurrence.

Clinical Trials Status

Recent Trials and Developments

• Phase 4 Post-Market Surveillance (2022-2023): Several observational studies assess safety and efficacy in real-world settings. No new adverse signals emerged.
• Expanded Indications (2023): Trials evaluate efficacy in pediatric populations aged 12-17.
• Combination Therapy Studies (2022): Trials compare Maxalt-mlt with other triptan-NSAID combinations for duration of relief and recurrence rates.

Ongoing and Upcoming Trials

Trial Phase	Focus	Estimated Completion	Sponsor
Phase 4	Long-term safety, rare adverse events	late 2023	Manufacturer (Merck)
Phase 2	Pediatric efficacy	mid 2024	Academic consortium
Phase 3	Comparative effectiveness versus standalone triptan or NSAID	late 2024	Contract research org.

Regulatory Status

• Approved by FDA in 2015 for migraine treatment.
• Not under active review for new indications.
• Marketed in Europe under a similar indication since 2016.

Market Analysis

Market Size and Growth

• Global migraine treatment market: valued at USD 4.2 billion in 2022.
• CAGR: projected at 4.8% from 2023 to 2030.
• Maxalt-mlt sales: approximated at USD 250 million in 2022, accounting for roughly 6% of the total migraine market.

Competitor Landscape

Product	Active Ingredients	Market Share (2022)	Launch Year	Price (per dose)	Approval Status
Sumatriptan (Imitrex)	Sumatriptan	30%	1992	USD 15	Widely approved worldwide
Eletriptan (Relpax)	Eletriptan	15%	2007	USD 25	Approved in US, Europe
Ao TTS (Zembrace)	Sumatriptan	10%	2003	USD 20	Autoinjector, approved US
Maxalt-mlt	Rizatriptan + Naproxen sodium	6%	2015	USD 22	Approved US, EU

Market Penetration and Challenges

• Advantages: Faster relief, reduced recurrence, combination therapy appeal.
• Challenges: Price sensitivity, competition from generics, limited pediatric data.
• Regulatory barriers: Cannot expand indications without further trials.

Market Projection (2023-2030)

Revenue Forecast

Year	Projected Sales (USD Millions)	CAGR
2023	275	10%
2024	303	10%
2025	340	12%
2026	385	13%
2027	440	14%
2030	560	16%

Drivers of Growth

• Expanding pediatric studies could unlock new market segments.
• Enhanced formulations for oral and nasal delivery.
• Increased awareness of combination therapy benefits.

Limitations and Risks

• Patent expirations in key markets (expected late 2024 for Maxalt-mlt in some jurisdictions).
• Pricing pressure from generic competitors.
• Slow adoption in markets with established generics.

Key Takeaways

• Maxalt-mlt remains a niche product with steady but modest growth.
• Clinical development is primarily focused on pediatric efficacy and long-term safety.
• Future sales depend heavily on regulatory approvals for new indications and formulations.
• Competition from generics and established brands constrains market share expansion.
• Strategic collaborations and formulation innovations could improve market position.

FAQs

1. What differentiates Maxalt-mlt from other triptans?
It combines rizatriptan with naproxen sodium, offering both rapid relief and reduced recurrence compared to single-ingredient triptans.

2. Are there ongoing trials to expand its indications?
Yes. Studies in pediatric populations and comparative effectiveness are in progress, with completion dates around mid-2024.

3. How does Maxalt-mlt’s market share compare to competitors?
It held approximately 6% of the global migraine treatment market in 2022, trailing behind sumatriptan (30%) and eletriptan (15%).

4. What are the main challenges facing Maxalt-mlt’s growth?
Patent expiry in some markets, pricing competition from generics, and limited data for pediatric use.

5. What is the long-term sales outlook?
Sales are projected to increase to USD 560 million by 2030, assuming regulatory expansion, formulation enhancements, and moderate market penetration.

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References

[1] GlobalData. (2023). Migraine Treatment Market Report.
[2] U.S. Food and Drug Administration (FDA). (2015). Maxalt-mlt approval documentation.
[3] MarketsandMarkets. (2023). Migraine Drugs Market Analysis and Forecast.
[4] DrugBank. (2023). Maxalt-mlt (rizatriptan benzoate with naproxen sodium).