CLINICAL TRIALS PROFILE FOR DIHYDROERGOTAMINE MESYLATE

All Clinical Trials for DIHYDROERGOTAMINE MESYLATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01089062 ↗	Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure	Completed	MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan	Phase 1	2010-03-01	Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
NCT01089062 ↗	Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure	Completed	Allergan	Phase 1	2010-03-01	Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
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.
NCT00203268 ↗	A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity	Completed	Bausch Health Americas, Inc.	N/A	2003-12-01	This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.
NCT00203268 ↗	A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity	Completed	Valeant Pharmaceuticals International, Inc.	N/A	2003-12-01	This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.
NCT00203268 ↗	A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity	Completed	Thomas Jefferson University	N/A	2003-12-01	This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches.This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.

Clinical Trial Conditions for DIHYDROERGOTAMINE MESYLATE

Condition Name

Condition Name for DIHYDROERGOTAMINE MESYLATE
Intervention	Trials
Migraine	7
Migraine With Aura	5
Migraine Without Aura	5
Healthy	3

Condition MeSH

Condition MeSH for DIHYDROERGOTAMINE MESYLATE
Intervention	Trials
Migraine Disorders	11
Migraine without Aura	5
Migraine with Aura	5
Headache	2

Clinical Trial Locations for DIHYDROERGOTAMINE MESYLATE

Trials by Country

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Trials by Country for DIHYDROERGOTAMINE MESYLATE
Location	Trials
United States	93
Brazil	4
United Kingdom	2
Australia	1
China	1

Trials by US State

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Trials by US State for DIHYDROERGOTAMINE MESYLATE
Location	Trials
Florida	5
North Carolina	4
California	4
Pennsylvania	4
Virginia	3

Clinical Trial Progress for DIHYDROERGOTAMINE MESYLATE

Clinical Trial Phase

Clinical Trial Phase for DIHYDROERGOTAMINE MESYLATE
Clinical Trial Phase	Trials
Phase 3	5
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for DIHYDROERGOTAMINE MESYLATE
Clinical Trial Phase	Trials
Completed	10
Recruiting	2
Enrolling by invitation	1

Clinical Trial Sponsors for DIHYDROERGOTAMINE MESYLATE

Sponsor Name

Sponsor Name for DIHYDROERGOTAMINE MESYLATE
Sponsor	Trials
Satsuma Pharmaceuticals, Inc.	5
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan	4
Allergan	4

Sponsor Type

Sponsor Type for DIHYDROERGOTAMINE MESYLATE
Sponsor	Trials
Industry	20
Other	3

Dihydroergotamine Mesylate: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Approval

FDA Approval and Clinical Trials

Dihydroergotamine mesylate has recently gained significant attention with the FDA approval of its nasal spray formulation, Trudhesa, for the acute treatment of migraine with or without aura in adults. This approval was based on the results of the phase 3, open-label, pivotal STOP 301 trial, which involved more than 5,650 migraine attacks treated over 24 or 52 weeks. The trial demonstrated that Trudhesa was generally well tolerated and provided rapid, sustained, and consistent symptom relief, even when administered hours after the onset of a migraine attack[1].

Efficacy and Safety

The efficacy of dihydroergotamine mesylate nasal spray was evaluated in several randomized, double-blind, placebo-controlled studies. These studies showed that the nasal spray significantly reduced headache severity to mild or no pain within 2 and 4 hours after dosing, compared to the placebo group[3].

Ongoing and Future Trials

In addition to the approved Trudhesa, other formulations of dihydroergotamine mesylate are under development. For instance, Satsuma Pharmaceuticals is seeking regulatory approval for STS101, a novel dihydroergotamine nasal powder, which has completed its pivotal Phase 3 ASCEND study. This study focused on the long-term safety and efficacy of STS101 using Satsuma’s proprietary SMART™ (Simple MucoAdhesive Release Technology)[4].

Market Analysis

Market Size and Growth

The global dihydroergotamine mesylate market has been growing steadily. In 2018, the market was valued at millions of US dollars and is projected to reach a higher value by 2024, with a significant CAGR during the forecast period. The market growth is driven by increasing demand for effective migraine treatments and the introduction of new formulations such as nasal sprays and powders[5].

Market Segmentation

The market is segmented by product types, including 1 mL and 0.5 mL injections, tablets, and other forms. By application, the market is divided into hypotension, headache (including migraine), and other uses. Geographically, the market spans across North America, Europe, Asia Pacific, Middle East & Africa, and Latin America, with North America and Europe being key regions due to high prevalence of migraines and advanced healthcare infrastructure[5].

Key Players

Major players in the dihydroergotamine mesylate market include Boehringer Ingelheim, Euticals, OLON, TEVA, and AMRI. These companies are involved in the manufacturing and distribution of various formulations of dihydroergotamine mesylate, contributing to the market's growth and competitiveness[5].

Market Projections

Forecasted Market Size

From 2019 to 2024, the global dihydroergotamine mesylate market is expected to grow significantly, driven by the increasing incidence of migraines and the introduction of new, more convenient treatment options. The forecasted data suggests that the market will continue to expand, with a notable CAGR during the forecast period[5].

Regional Growth

North America and Europe are expected to remain key markets due to their large patient populations and advanced healthcare systems. However, emerging markets in Asia Pacific and Latin America are also anticipated to contribute significantly to the market's growth, driven by increasing healthcare spending and awareness about migraine treatments[5].

Technological Trends

The use of advanced delivery technologies, such as Satsuma’s SMART™ technology for nasal powder formulations, is expected to drive innovation in the market. These technologies enhance patient compliance and efficacy, making them more attractive to both patients and healthcare providers[4].

Pharmacokinetics and Pharmacodynamics

Absorption and Distribution

Dihydroergotamine mesylate, when administered intranasally, bypasses the gut and potential absorption issues, providing fast and consistent relief. It is 93% plasma protein bound, with an apparent steady-state volume of distribution of approximately 800 liters. The drug is metabolized into several metabolites, with the major metabolite exhibiting similar potency to the parent compound[3].

Metabolism and Excretion

The drug is primarily metabolized in the liver, with the systemic clearance being 1.5 L/min. The major excretory route is via the bile in the feces, with a terminal half-life of about 10 hours[3].

Key Takeaways

• FDA Approval: Dihydroergotamine mesylate nasal spray (Trudhesa) has been approved for the acute treatment of migraine.
• Clinical Trials: Positive results from phase 3 trials have demonstrated the efficacy and safety of dihydroergotamine mesylate nasal spray.
• Market Growth: The global market is projected to grow significantly, driven by increasing demand and new formulations.
• Technological Advancements: Advanced delivery technologies are enhancing patient compliance and treatment efficacy.
• Pharmacokinetics: Intranasal administration provides fast and consistent relief, with the drug being primarily metabolized in the liver.

FAQs

What is dihydroergotamine mesylate used for?

Dihydroergotamine mesylate is used for the acute treatment of migraine with or without aura in adults.

How is dihydroergotamine mesylate administered?

It can be administered through various forms, including nasal sprays, nasal powders, injections, and tablets.

What are the key benefits of the nasal spray formulation?

The nasal spray formulation bypasses the gut, providing fast, sustained, and consistent symptom relief even when taken late into a migraine attack.

Who are the major players in the dihydroergotamine mesylate market?

Major players include Boehringer Ingelheim, Euticals, OLON, TEVA, and AMRI.

What is the projected market growth for dihydroergotamine mesylate?

The market is expected to grow significantly from 2019 to 2024, driven by increasing demand and new formulations.

Sources

1. FDA Approves Dihydroergotamine Mesylate Nasal Spray for Acute Migraine Treatment - Pharmacy Times
2. Global Dihydroergotamine Mesylate Market Report 2024 Edition - Cognitive Market Research
3. Migranal® (dihydroergotamine mesylate) Nasal Spray - FDA
4. Satsuma Pharmaceuticals and SNBL Announce Publication of STS101 (Dihydroergotamine Nasal Powder) Pivotal Phase 3 ASCEND Study - BioSpace
5. Global Dihydroergotamine Mesylate Market Size, Share, Industry - Market Research Store