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

CAFERGOT (Ergotamine Tartrate + Caffeine): Clinical Trials Update, Market Analysis, and Projection

Last updated: May 4, 2026

What is CAFERGOT and what is its regulatory context?

CAFERGOT is a fixed-dose oral product that combines ergotamine tartrate with caffeine for the acute treatment of migraine. The product is marketed in some jurisdictions as a prescription medicine; in the US it has been associated historically with migraine acute-care use under older labeling frameworks.

How does CAFERGOT’s clinical-trial activity look right now?

No reliable, up-to-date, publicly indexed clinical trial dataset (registry record set and verifiable publication trail) that specifically tracks CAFERGOT as a unique drug product (not just ergotamine + caffeine as a class) was available in the provided context. Under strict source-verification, this prevents a complete, accurate “clinical trials update” for CAFERGOT as a branded combination.

What can be stated on record from public trial infrastructure is that clinical activity for ergotamine-caffeine is generally limited in modern registries relative to triptans, CGRP antagonists, and gepants, and most new migraine studies focus on newer mechanisms. This is consistent with the broader shift in migraine R&D pipelines, but it does not constitute a product-specific CAFERGOT trial update.

What is the likely market structure for CAFERGOT?

CAFERGOT’s market is shaped by five structural factors:

1. Therapeutic class competition

   • Triptans and newer agents have shifted prescribing away from older ergot combinations in many developed markets.
   • Use of ergot derivatives is constrained by tolerability and safety messaging tied to ergot vasoconstrictive risks.

2. Indication narrowness

   • CAFERGOT targets acute migraine rather than prophylaxis or broader headache syndromes.

3. Formulation and regimen

   • Fixed-dose oral use supports acute, early administration, but it competes against products that are easier to dose and better aligned with modern migraine acute algorithms.

4. Safety and labeling friction

   • Ergot-containing products typically face tighter contraindication handling (drug-drug interactions, vascular risk stratification), which reduces adoption in some prescriber segments.

5. Genericization and substitution

   • Many ergotamine-caffeine products are available as generics in multiple markets, which compresses branded price realization.

Where does CAFERGOT sit versus current migraine acute market leaders?

Without product-specific revenue and unit-registration data in the provided context, a precise revenue share table for CAFERGOT cannot be produced. A defensible projection must instead be structured as a market-access and demand proxy tied to migraine acute segmentation:

• Primary demand drivers
  • Volume growth in migraine prevalence is incremental for acute therapies.
  • Drug-switching is dominated by efficacy, ease of use, and safety profile.
• Primary headwinds
  • Higher share of newer acute therapies.
  • Generic availability and low differentiation.
• Primary tailwinds
  • Persistent need for oral acute options in settings where newer therapies are less accessible.

Market analysis by geography (framework)

A complete country-by-country market model for CAFERGOT requires verified branded pricing, dispensing, reimbursement rules, and sales reporting. In the absence of those inputs in the provided context, only a structural framework can be delivered:

Market dimension	Expected direction for CAFERGOT	Driver
Developed markets	Flat to declining	Shift to triptans, CGRP and gepants; generic substitution
Pricing pressure	Down	Genericization and therapeutic class competition
Access in lower-cost systems	Stable	Older oral acute option retains utilization
Formulary inclusion	Selective	Contraindications and safety administration
Competitive environment	Intensifying	New mechanisms expand acute options

What is the forecast for CAFERGOT (2026-2031)?

A quantified forecast cannot be produced without market sizing inputs that are verifiable for CAFERGOT as a unique product (or an explicitly mapped branded-to-generic equivalency dataset). In the strict sense, any numerical forecast would be speculative.

Instead, a projection can be expressed as a scenario outcome grounded in typical branded ergot-combination trajectories:

• Base case: mature-volume, price-compressed dynamics with modest unit stability or slow decline in developed markets.
• Downside case: continued formularies tightening and further substitution to newer acute agents reduces units.
• Upside case: regional retention of older oral acute regimens and continued generic supply stabilizes demand.

Key clinical and commercial implications for decision-makers

Even without a current registry-backed CAFERGOT-specific trial update, commercial implications are clear:

• Low probability of near-term differentiation via new clinical endpoints unless a company is running formal trials designed to support label expansions or safety updates.
• If a sponsor invests, the most commercially aligned path is likely not “new efficacy superiority” but either:
  • safety/label modernization, or
  • regimen optimization within existing acute migraine frameworks.

Key Takeaways

• CAFERGOT is an ergotamine tartrate + caffeine acute migraine product.
• A source-verified, product-specific clinical trials update for CAFERGOT cannot be completed from the provided context using strict registry-and-publication verification rules.
• Market dynamics for ergotamine-caffeine products trend toward mature use, pricing compression, and substitution by newer acute migraine therapies in developed markets.
• Quantified 2026-2031 projections for CAFERGOT cannot be produced without verifiable product-level sales/market data in the provided context; scenario-based outlook indicates flat-to-declining commercial trajectory in higher-access markets.

FAQs

1. Is CAFERGOT considered a modern migraine acute standard?
   It is typically a mature, older oral acute option that competes with triptans and newer migraine agents.

2. Does CAFERGOT have ongoing clinical trials listed in major registries?
   A product-specific, source-verified CAFERGOT trial update cannot be produced from the provided context.

3. What limits broader adoption of ergotamine-caffeine products?
   Safety constraints tied to ergot vasoconstrictive effects and contraindication-heavy labeling reduce flexibility versus newer acute therapies.

4. How does generic substitution affect CAFERGOT’s commercial performance?
   Generic availability usually compresses branded pricing and reduces differentiation-based demand.

5. What would likely change CAFERGOT’s market outlook?
   Any new, registrable product differentiation (formulation, dosing regimen, or label modernization) or a shift in formulary behavior toward older oral acute options.

References

[1] FDA. (n.d.). Drugs@FDA: FDA-approved drug products. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] ClinicalTrials.gov. (n.d.). Search results for ergotamine caffeine migraine. U.S. National Library of Medicine. https://clinicaltrials.gov/
[3] WHO. (n.d.). ATC/DDD Index. World Health Organization Collaborating Centre for Drug Statistics Methodology. https://www.whocc.no/atc_ddd_index/
[4] EMA. (n.d.). European Union medicines. European Medicines Agency. https://www.ema.europa.eu/en/medicines