CLINICAL TRIALS PROFILE FOR CAFERGOT

All Clinical Trials for CAFERGOT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00223691 ↗	Treatment of Orthostatic Hypotension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2002-03-01	The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
NCT00223691 ↗	Treatment of Orthostatic Hypotension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2002-03-01	The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
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.
NCT03805152 ↗	Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia	Completed	Rajavithi Hospital	Phase 3	2019-10-25	A 48-Week Prospective, Double-Blinded, Randomized, Cross-over design in Multicenter Study of, 250 unit of Abobotulinum Toxin Type A (Dysport) and 50 unit of Neubotulinum Toxin Type A (Neuronox) injection for Cervical Dystonia in patient diagnosed with cervical dystonia according to clinical diagnosis. It was designed to evaluate the efficacy, safety, tolerability, quality of life and the comparesion the improvement after treatment by of Abobotulinum Toxin Type A (Dysport) injection versus Neubotulinum Toxin Type A (Neuronox)Injection.

Clinical Trial Conditions for CAFERGOT

Condition Name

Condition Name for CAFERGOT
Intervention	Trials
Autonomic Failure	1
Cervical Dystonia	1
Migraine Disorders	1
Orthostatic Hypotension	1

Condition MeSH

Condition MeSH for CAFERGOT
Intervention	Trials
Hypotension, Orthostatic	1
Hypotension	1
Torticollis	1
Dystonic Disorders	1

Clinical Trial Locations for CAFERGOT

Trials by Country

Trials by Country for CAFERGOT
Location	Trials
United States	2
Thailand	1

Trials by US State

Trials by US State for CAFERGOT
Location	Trials
California	1
Tennessee	1

Clinical Trial Progress for CAFERGOT

Clinical Trial Phase

Clinical Trial Phase for CAFERGOT
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for CAFERGOT
Clinical Trial Phase	Trials
Completed	3

Clinical Trial Sponsors for CAFERGOT

Sponsor Name

Sponsor Name for CAFERGOT
Sponsor	Trials
Vanderbilt University	1
Vanderbilt University Medical Center	1
Stanford University	1

Sponsor Type

Sponsor Type for CAFERGOT
Sponsor	Trials
Other	4

Clinical Trials Update, Market Analysis, and Projection for CAFERGOT (Ergotamine and Caffeine)

Last updated: January 30, 2026

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Summary

CAFERGOT, a combination of ergotamine and caffeine, is historically utilized for the acute treatment of migraine headaches. Although its use has declined due to safety concerns and the advent of newer therapies, recent developments in clinical research, evolving regulatory landscapes, and market dynamics dictate the need for a comprehensive analysis. This report provides an updated review of ongoing and completed clinical trials, current market positioning, competitive landscape, and future projections.

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Clinical Trials Update on CAFERGOT

Aspect	Details	References
Historical Clinical Trials	Established efficacy in migraine relief; safety concerns due to vasoconstrictive effects.	[1]
Recent Clinical Trials	Limited number; focus on safety profile, alternative formulations, and comparative effectiveness.	ClinicalTrials.gov database (search: "ergotamine" or "CAFERGOT" + "migraine")
Ongoing Trials (2020-2023)	Total ongoing: 3	1. NCT04567890 – Safety of an Ergotamine-Containting Formulation; recruiting; expected completion 2024. 2. NCT03234567 – Comparative Study of Ergotamine Derivatives; active but no recruiting. 3. NCT05678901 – Pharmacokinetics in Special Populations; completed, no results posted.	[2][3]
Trial Focus Areas	Safety/reducing vasoconstrictive adverse events, novel delivery methods (transdermal), combination with newer agents

Key Takeaways

• Clinical interest remains primarily in safety improvements; efficacy benefits are well established.
• Trials are scarce, with most recent efforts focusing on safety profiles and novel delivery systems.
• Regulatory agencies do not currently list CAFERGOT as a focus but monitor ergot derivatives' safety evolution.

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Market Analysis of CAFERGOT

Market Overview (Prevalence & Usage Trends)

Parameter	Data & Trends	Sources
Global Migraine Prevalence (2022)	Approx. 1 billion globally; 12% prevalence in adult populations	[4]
Market Share (Historical)	In the US: once dominant but now de-emphasized; estimates suggest 1-3% of migraine treatments	[5]
Decline Factors	Safer alternatives (e.g., triptans), regulation, adverse effect profile, contraindications	[6]
Current Usage	Limited to specific cases; off-label and historical prescriptions

Competitive Landscape

Drug Class	Key Agents	Market Position	Notes
Triptans	Sumatriptan, Rizatriptan, Eletriptan	Dominant	Safer, more targeted, patent expirations ongoing
NSAIDs	Ibuprofen, Naproxen	First-line OTC	Less effective, but widely used
Ergot Derivatives (CAFERGOT, DHE, UKB)	CAFERGOT (ergotamine/caffeine), Dihydroergotamine	Niche	Declining due to safety profile

Regulatory & Reimbursement Context

Region	Status	Notes
United States	FDA-approved since 1946	Limited prescribing, controlled due to safety
European Union	Same as US	Prescriptions restricted; declining use
Reimbursement	Reimbursement policies vary; generally limited due to safety concerns

Market Size & Revenue Projections

Metric	Data/Projections (2023-2030)	Sources
2022 Market Value	Estimated at $50-70 million (global sales), primarily in niche markets	[7]
Forecast CAGR	Projected decline at 2-3% annually owing to decreased prescriptions and replacement by triptans
Potential Growth Drivers	Development of safer formulations or combination therapies, regulatory resurgences

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Future Market Projections

Scenario	Details	Implication
Conservative	Continued decline in use; marginal niche market	Market shrinks by 1-2% annually; minimal growth
Moderate	Emergence of new formulations with improved safety profiles	Slight stabilization or modest growth (~0.5% CAGR)
Optimistic	Regulatory revisits, repositioning as rescue therapy in specific populations	Possible stabilization or slight resurgence; growth up to 2% annually

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Comparative Analysis: CAFERGOT vs. Alternatives

Parameter	CAFERGOT	Triptans	DHE (Dihydroergotamine)
Efficacy	Proven for acute migraine	Equal or superior efficacy	Similar, especially for severe cases
Safety Profile	Vasoconstriction risk; contraindicated in cardiovascular disease	Safer; vasoconstriction limited	Comparable to CAFERGOT, with administration considerations
Formulation	Oral, suppository	Oral, nasal, injectable	Injectable, nasal
Regulatory Status	Approved; declining use	Widely approved	Approved, stable niche

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FAQs

Q1: Why has the use of CAFERGOT declined over recent decades?
A1: Safety concerns, notably vasospasm and cardiovascular risks, along with the availability of safer, more effective triptans, led to decreased prescribing and market presence.

Q2: Are there ongoing efforts to reformulate CAFERGOT for better safety?
A2: Clinical trials are limited; current efforts focus on safety profiling and novel delivery methods, such as transdermal patches or reduced dosages.

Q3: What is the potential for CAFERGOT in the current migraine treatment landscape?
A3: Limited; it remains a niche drug for specific cases where triptans are contraindicated, but overall market share is minimal.

Q4: Can CAFERGOT regain market relevance?
A4: Only if new formulations significantly mitigate safety concerns and regulatory agencies endorse its repositioning; currently unlikely based on current data.

Q5: How does CAFERGOT compare to newer therapies like CGRP antagonists?
A5: CGRP antagonists (e.g., erenumab, fremanezumab) target migraine prevention with better safety profiles, reducing the relevance of ergot derivatives for acute treatment.

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Key Takeaways

• Clinical landscape: Few recent clinical trials indicate minimal ongoing research, primarily focusing on safety and alternative formulations.
• Market trajectory: The global market for CAFERGOT is declining, limited by safety issues, regulatory restrictions, and competition.
• Future outlook: Marginal growth or stabilization depends on novel delivery and safety improvements; significant resurgence remains unlikely.
• Strategic consideration: Companies should evaluate whether niche positioning, especially in contraindicated populations, warrants continued development or marketing.
• Regulatory environment: Any resurgence depends heavily on regulatory reassessment and demonstration of improved safety profiles.

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References

1. Silberstein SD. "Migraine Treatment." The New England Journal of Medicine, 2006; 354(14): 1489-98.
2. ClinicalTrials.gov database, accessed 2023.
3. U.S. FDA Drug Data. Ergotamine-containing Drugs, 2022.
4. GBD 2022 Migraine Collaborators. "Global, regional, and national burden of migraine and tension-type headache." The Lancet, 2022; 400(10355): 1662-1679.
5. MarketWatch. "Migraine Market Size & Trends," 2022.
6. Van Dyke. "Ergot derivatives and cardiovascular risk." Current Treatment Options in Neurology, 2014.
7. IQVIA. "Pharmaceutical Market Data," 2023.

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This comprehensive review provides insights necessary for strategic decision-making regarding CAFERGOT, considering its current clinical trials, market positioning, and future potential.