CLINICAL TRIALS PROFILE FOR IMITREX

All Clinical Trials for Imitrex

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00399243 ↗	Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache	Unknown status	GlaxoSmithKline	Phase 4	2006-11-01	This study's hypothesis is the 4mg StatDose sumatriptan is effective for the acute treatment of cluster headache and provides good safety and tolerability across multiple doses of the study medication as well as across multiple attacks of cluster headache. This study seeks to determine the safety and efficacy of the commercially available 4mg StatDose formulation of sumatriptan as an acute treatment of cluster headache. Patients are allowed to use repeated dose of the study medication for a given headache if they have had a partial response to the first dose. They may treat up to 3 attacks of cluster headache with the study medication. Safety assessment will be through adverse event reporting and physical examination. Patients with both episodic cluster headache as well as chronic cluster headache will be studied. Patients must either not have started preventive treatment for cluster headache or be on a stable dose of preventive medication.
NCT00399243 ↗	Sumatriptan 4 mg Statdose in the Acute Treatment of Cluster Headache	Unknown status	Diamond Headache Clinic	Phase 4	2006-11-01	This study's hypothesis is the 4mg StatDose sumatriptan is effective for the acute treatment of cluster headache and provides good safety and tolerability across multiple doses of the study medication as well as across multiple attacks of cluster headache. This study seeks to determine the safety and efficacy of the commercially available 4mg StatDose formulation of sumatriptan as an acute treatment of cluster headache. Patients are allowed to use repeated dose of the study medication for a given headache if they have had a partial response to the first dose. They may treat up to 3 attacks of cluster headache with the study medication. Safety assessment will be through adverse event reporting and physical examination. Patients with both episodic cluster headache as well as chronic cluster headache will be studied. Patients must either not have started preventive treatment for cluster headache or be on a stable dose of preventive medication.
NCT00546650 ↗	Phase I Study to Compare NP101(Sumatriptan Iontophoretic Transdermal Patch) With Three Formulations of Imitrex®	Completed	NuPathe Inc.	Phase 1	2007-11-01	The primary objective is to compare the pharmacokinetics (PK) of NP101 with the currently approved oral, injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection. The secondary objective is to evaluate the safety of NP101 in healthy volunteers.
NCT00573599 ↗	Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department	Completed	United States Naval Medical Center, Portsmouth	N/A	2007-02-01	ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.
NCT00648466 ↗	Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg	Completed	Mylan Pharmaceuticals	Phase 1	2004-11-01	The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fasting conditions.
NCT00650247 ↗	Food Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg	Completed	Mylan Pharmaceuticals	Phase 1	2004-11-01	The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administered under fed conditions.
NCT00723983 ↗	Phase I, Open Label, Single-Dose, Four Way Crossover Study to Compare the PK of NP101 With Oral Imitrex® (50mg) in Migraine Subjects During an Acute Migraine Attack and During a Non-Migraine Period	Completed	NuPathe Inc.	Phase 1	2008-11-01	To compare the pharmacokinetics of NP101 with a currently approved oral formulation of Imitrex® (50 mg) in migraine subjects both during an acute migraine attack and during a non-migraine period.

Clinical Trial Conditions for Imitrex

Condition Name

Condition Name for Imitrex
Intervention	Trials
Healthy	8
Migraine	6
Migraine Disorders	3
Healthy Subjects	1

Condition MeSH

Condition MeSH for Imitrex
Intervention	Trials
Migraine Disorders	8
Headache	4
Cluster Headache	1
Post-Traumatic Headache	1

Clinical Trial Locations for Imitrex

Trials by Country

Trials by Country for Imitrex
Location	Trials
United States	20
India	3
Belgium	1
Canada	1

Trials by US State

Trials by US State for Imitrex
Location	Trials
Florida	3
Washington	2
West Virginia	2
Virginia	2
Maryland	2

Clinical Trial Progress for Imitrex

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for Imitrex
Clinical Trial Phase	Trials
Completed	20
Unknown status	3

Clinical Trial Sponsors for Imitrex

Sponsor Name

Sponsor Name for Imitrex
Sponsor	Trials
GlaxoSmithKline	5
NuPathe Inc.	3
CoLucid Pharmaceuticals	2

Sponsor Type

Sponsor Type for Imitrex
Sponsor	Trials
Industry	26
Other	6
U.S. Fed	1

IMITREX (Sumatriptan): Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy

Migraine Treatment

IMITREX (sumatriptan) has been extensively studied in clinical trials for its efficacy in treating migraines. In controlled clinical trials, IMITREX injection and tablets have shown significant effectiveness in alleviating migraine symptoms. For instance, studies involving patients with migraines treated with a single 6-mg dose of IMITREX injection or placebo demonstrated that IMITREX was superior to placebo in reducing migraine symptoms[1][4].

Cluster Headache Treatment

In addition to migraines, IMITREX has been evaluated for the treatment of cluster headaches. Clinical trials (Studies 4 and 5) indicated that IMITREX injection is effective in treating cluster headaches, although the frequency of adverse reactions was generally lower compared to migraine trials. Notable adverse reactions in cluster headache trials included paresthesia, nausea, vomiting, and bronchospasm[1].

Adverse Reactions

Clinical trials have identified various adverse reactions associated with IMITREX. Common adverse reactions include atypical sensations such as tingling, warm/hot sensation, burning sensation, and pressure sensation. Cardiovascular effects like flushing and chest discomfort have also been reported. These reactions are generally well-tolerated, but significant cardiovascular and cerebrovascular events, though rare, necessitate careful patient selection and adherence to prescribing recommendations[1][4].

Market Analysis

Global Market Size and Growth

The global Sumatriptan Succinate market, which includes IMITREX, is projected to be substantial. As of 2024, the market size is estimated at USD 2615.2 million and is expected to grow at a compound annual growth rate (CAGR) of 12.30% from 2024 to 2031[2].

Regional Market Breakdown

• North America: This region accounts for more than 40% of the global revenue, with a market size of USD 1046.08 million in 2024. The market here is driven by a well-regulated healthcare environment, an aging population, and technological advancements in healthcare[2].
• Europe: Europe holds over 30% of the global market share, with a market size of USD 784.56 million. The region's robust healthcare infrastructure and extensive research capabilities contribute to its significant market presence[2].
• Asia Pacific: This region accounts for around 23% of the global revenue, with a market size of USD 601.50 million. The growing population and improving healthcare infrastructure are key drivers of the market here[2].
• Middle East and Africa: This region constitutes a smaller but growing market, with a size of USD 52.30 million in 2024. Despite challenges such as varying healthcare infrastructures and economic constraints, the market is expected to grow at a CAGR of 12.0% from 2024 to 2031[2].

Market Drivers

The growth of the Sumatriptan Succinate market is driven by several factors:

• Increasing Prevalence of Migraines: The rising incidence of migraines globally is a significant driver.
• Technological Advancements: Innovations in healthcare technology, including advancements in injection technologies and patient training for self-administration, are boosting the market.
• Regulatory Frameworks: Strong regulatory frameworks in regions like North America and Europe ensure product safety and efficacy, fostering market growth[2][5].

Market Projections

Forecasted Growth

The Sumatriptan Succinate market is expected to expand rapidly over the forecast period from 2024 to 2031. The CAGR varies by region, with North America expected to grow at 10.5%, Europe at 10.8%, and Asia Pacific at 14.3%[2].

Opportunities and Challenges

• Opportunities: The market presents opportunities for stakeholders to capitalize on patient-centric solutions, continued innovation, and adaptability to changing healthcare landscapes.
• Challenges: Challenges include navigating regulatory landscapes, addressing economic considerations, and focusing on education and awareness initiatives, especially in regions like the Middle East and Africa[2].

Key Takeaways

• Clinical Efficacy: IMITREX has demonstrated efficacy in treating migraines and cluster headaches through extensive clinical trials.
• Market Size and Growth: The global Sumatriptan Succinate market is substantial and projected to grow significantly over the next several years.
• Regional Dynamics: Different regions have unique market dynamics driven by factors such as healthcare infrastructure, regulatory frameworks, and population demographics.
• Market Drivers: The market is driven by the increasing prevalence of migraines, technological advancements, and strong regulatory frameworks.

FAQs

What is IMITREX used for?

IMITREX (sumatriptan) is used for the acute treatment of migraines with or without aura and cluster headaches in adults[1][4].

What are the common adverse reactions associated with IMITREX?

Common adverse reactions include atypical sensations like tingling, warm/hot sensation, burning sensation, and pressure sensation, as well as cardiovascular effects such as flushing and chest discomfort[1][4].

How large is the global Sumatriptan Succinate market?

As of 2024, the global Sumatriptan Succinate market size is estimated at USD 2615.2 million[2].

What is the projected growth rate of the Sumatriptan Succinate market?

The market is expected to grow at a CAGR of 12.30% from 2024 to 2031[2].

Which region has the largest share of the Sumatriptan Succinate market?

North America holds more than 40% of the global revenue, with a market size of USD 1046.08 million in 2024[2].

Sources

1. FDA Label: IMITREX (sumatriptan) Label - accessdata.fda.gov
2. Cognitive Market Research: Sumatriptan Succinate Market Report 2024 (Global Edition)
3. PubMed: Tolerability of sumatriptan: clinical trials and post-marketing ...
4. GSKPro: IMITREX (sumatriptan) tablets - GSKPro for Healthcare Professionals
5. BioSpace: Injectable Sumatriptan Market Growth 2022-2028 - BioSpace