CLINICAL TRIALS PROFILE FOR MIGRANAL

All Clinical Trials for MIGRANAL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03401346 ↗	Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults	Completed	Impel NeuroPharma Inc.	Phase 1	2017-10-19	A Phase I clinical trial to compare the bioavailability of dihydroergotamine mesylate (DHE) following a single dose administration of INP104 (DHE administered by I123 Precision Olfactory Delivery (POD) Device Nasal Spray) to that of D.H.E. 45 for Injection (Intravenous) and Migranal Nasal Spray in healthy adult subjects. It is hypothesized that INP104 will address the current variability in nasal administration and give more reproducible dose delivery compared to Migranal nasal spray. Blood concentrations of all three investigational products will be compared for 48 hours following dosing. The safety and tolerability of INP104 will be monitored throughout the study. INP104 has been developed for the treatment of acute migraine headache. The device in which the drug will be delivered has been designed to deliver the medication to the upper nasal cavity with minimal variation in dose absorption, eg loss via dripping out of the nose or the dose being swallowed. Approximately 36 participants in general good health (equal ratio of males and females desired) will be enrolled and will be allocated to receive 3 treatments in a randomized sequence. They will receive a single dose of INP104, a single dose of DHE via intravenous injection, and a single dose of Migranal Nasal Spray. There will be a wash out period where no treatment will be administered for 7 days in between each treatment. Participants are required to attend 3 inpatient periods and 1 final outpatient visit. Each participant will be in the study for up to 43 days.
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.
NCT00335777 ↗	A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine	Completed	Thomas Jefferson University	Phase 4	2006-08-01	This is a research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about allodynia may help us understand how the pain system works in migraine. This study will compare the differences, if any, in attacks treated early with study drug (at 1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one attack early and one attack late for this study. If the first attack you treat is early (at 1 hour following onset of throbbing pain) then the second attack you treat should be late (at 4 hours following onset of throbbing pain). It is hoped that this study will provide information on the use of Migranal in subjects who have cutaneous allodynia. The results from this study may be used in the development of larger clinical trials. The study drug is a medication that is taken in the form of nasal spray.

Clinical Trial Conditions for MIGRANAL

Condition Name

Condition Name for MIGRANAL
Intervention	Trials
Migraine	1
Migraine Disorders	1
Migraine Headache	1

Condition MeSH

Condition MeSH for MIGRANAL
Intervention	Trials
Migraine Disorders	3
Headache	1

Clinical Trial Locations for MIGRANAL

Trials by Country

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−

Trials by Country for MIGRANAL
Location	Trials
United States	2
Australia	1

Trials by US State

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−

Trials by US State for MIGRANAL
Location	Trials
California	1
Pennsylvania	1

Clinical Trial Progress for MIGRANAL

Clinical Trial Phase

Clinical Trial Phase for MIGRANAL
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for MIGRANAL
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for MIGRANAL

Sponsor Name

Sponsor Name for MIGRANAL
Sponsor	Trials
Thomas Jefferson University	1
Stanford University	1
Impel NeuroPharma Inc.	1

Sponsor Type

Sponsor Type for MIGRANAL
Sponsor	Trials
Other	2
Industry	1

Migranal and the Evolving Landscape of Migraine Treatment: Clinical Trials, Market Analysis, and Projections

Introduction to Migranal and Migraine Treatment

Migranal, a brand name for the drug dihydroergotamine, is a well-established treatment for acute migraine attacks. However, the migraine treatment landscape is rapidly evolving with the introduction of new therapies, particularly those targeting the calcitonin gene-related peptide (CGRP).

Clinical Trials: The Shift Towards CGRP Inhibitors

Recent clinical trials have highlighted the efficacy of CGRP inhibitors over traditional treatments like Migranal. For instance, the APPRAISE trial compared the long-term outcomes of erenumab, a CGRP inhibitor, against nonspecific oral migraine preventives. This trial demonstrated that erenumab significantly outperformed oral prophylactics in reducing monthly migraine days (MMDs) and improving patient response rates[1].

Another significant study involved galcanezumab, another CGRP inhibitor, which showed statistically significant reductions in monthly migraine headache days compared to placebo. Galcanezumab also exhibited a favorable tolerability profile, with low discontinuation rates due to adverse events[4].

Market Analysis: The Rise of CGRP Inhibitors

The migraine drugs market is experiencing significant growth, largely driven by the adoption of CGRP inhibitors.

Current Market Size and Growth

As of 2023, the migraine drugs market was valued at approximately $4.2 billion and is projected to reach $6.3 billion by 2032, growing at a compound annual growth rate (CAGR) of 4.3% during this period[3].

Regional Market Projections

Across the seven major markets (7MM), the migraine market is expected to grow from $9.2 billion in 2023 to $16.4 billion by 2033, with a CAGR of 6.0%. This growth is primarily driven by the increased prescription of CGRP antagonists, including monoclonal antibodies and oral gepants[2].

Impact of CGRP Inhibitors on Market Growth

CGRP inhibitors like erenumab and galcanezumab are driving market growth due to their superior efficacy and tolerability compared to traditional treatments. These drugs have shown significant reductions in migraine frequency and are preferred by both healthcare practitioners and patients[3].

Challenges and Limitations

Despite the promising outlook, there are several challenges that could impact the widespread adoption of CGRP inhibitors:

Reimbursement Restrictions

The higher annual costs of CGRP inhibitors compared to generic drugs may limit their adoption due to reimbursement restrictions. This could be a significant barrier, especially in regions with stringent healthcare budgets[2].

Patent Expiries

The patent expiries of branded CGRP inhibitors towards the end of the forecast period could also affect market dynamics. However, this may also open up opportunities for generic versions, potentially increasing accessibility[2].

Future Pipeline and Innovations

The migraine treatment pipeline is robust, with several late-stage products expected to enter the market. While most of these products focus on acute treatment and are reformulations or combination therapies, there are also novel preventive treatments in development. One of the late-stage pipeline drugs targets migraine prevention with a novel mechanism of action, which could further diversify treatment options[2].

Market Recommendations and Guidelines

The American Headache Society has recommended the use of anti-CGRP mAbs and gepants as first-line preventive options due to their superior efficacy and tolerability. However, the implementation of these recommendations by insurance companies remains to be seen[2].

Patient and Practitioner Preferences

The choice between traditional treatments like Migranal and newer CGRP inhibitors often depends on patient and practitioner preferences. CGRP inhibitors are increasingly preferred due to their effectiveness and safety profiles. For example, erenumab has been shown to reduce monthly migraine days by up to 50% in certain individuals, providing significant relief for those suffering from episodic and chronic migraine[3].

Key Takeaways

• CGRP Inhibitors: Erenumab and galcanezumab have demonstrated superior efficacy and tolerability in clinical trials, driving market growth.
• Market Growth: The migraine drugs market is expected to grow significantly, reaching $6.3 billion by 2032 and $16.4 billion across the 7MM by 2033.
• Challenges: Reimbursement restrictions and patent expiries could impact the adoption of CGRP inhibitors.
• Future Pipeline: Several late-stage products, including novel preventive treatments, are expected to enter the market.
• Recommendations: Anti-CGRP mAbs and gepants are recommended as first-line preventive options by the American Headache Society.

FAQs

What are the main drivers of the migraine drugs market growth?

The main drivers include the increasing prevalence of migraines, advancements in novel therapies such as CGRP inhibitors, and the rising adoption of these treatments due to their superior efficacy and tolerability[3].

How do CGRP inhibitors compare to traditional migraine treatments?

CGRP inhibitors like erenumab and galcanezumab have shown significantly better outcomes in reducing monthly migraine days and improving patient response rates compared to traditional oral prophylactics and acute treatments[1][4].

What are the challenges facing the widespread adoption of CGRP inhibitors?

Reimbursement restrictions due to higher costs and the impending patent expiries of branded drugs are significant challenges[2].

What is the projected market size for migraine drugs by 2032?

The migraine drugs market is expected to reach $6.3 billion by 2032, growing at a CAGR of 4.3% from 2023[3].

Are there any new treatments in the pipeline for migraine prevention?

Yes, several late-stage products are expected to enter the market, including one with a novel mechanism of action for migraine prevention[2].

Sources

1. Early Use of Erenumab vs Nonspecific Oral Migraine Preventives. JAMA Neurology, 2024.
2. Migraine market expected to reach $16.4bn across 7MM by 2033. Clinical Trials Arena, 2024.
3. Migraine Drugs Market Size to Reach USD 6.3 Billion by 2032. BioSpace, 2024.
4. Evaluation of Galcanezumab for the Prevention of Episodic Migraine. JAMA Neurology, 2018.
5. Global Migraine Drugs Market Set to Reach $7 Billion by 2025. GlobeNewswire, 2019.