Migraine sufferer … you can make a difference in the development of an investigational drug

As a volunteer for our migraine studies, you can enjoy benefits such as …

  • Be a part of cutting edge of migraine science
  • Gain insight and become your own expert.
  • Help find a potential treatment that will help migraine sufferers
  • Advance scientific knowledge by sharing your experience.
  • Experience first hand the thrill of scientific exploration
  • Receive all study-related exams and medications at no cost
  • Receive financial compensation for your time and travel
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Nausea Associated with Migraines Represents a Significant Unmet Treatment Need

Migraine-associated nausea represents a significant unmet treatment need. There is a need for a new drug that will address not only headache pain but other migraine-associated symptoms, especially nausea.

A Clinical trial with medications that represent the current standard of care for migraines, sumatriptan, NSAIDS, and a combination of the two (sumatriptan/naproxen) showed no difference from placebo for the absence of nausea at 2 hours after dosing. This supports the argument that nausea in episodic migraines represents a high degree of unmet treatment need. A summary of findings of the study “Sumatriptan-Naproxen for Acute Treatment of Migraine Clinical Trial”[1] is presented in the table below.

Absence of nausea at 2 hours
Sumatriptan /Naproxen Sodium, No. (%)
Sumatriptan, No. (%)
Naproxen Sodium, No. (%)
Placebo, No. (%)
P Value Sumatriptan/ Naproxen Sodium vs. Placebo
P Value Sumatriptan/ Naproxen Sodium vs Sumatriptan
Study 2
237 (65)
233 (64)
249 (68)
244 (64)
.71
.56

[1] Brandes JL, Kudrow D, Stark SR, et al. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007;297(13):1443-54

 

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Migraine-associated nausea is an Important Target for Treatment

American Migraine Prevalence and Prevention (AMPP) Study” [1] showed:

“Among the 6488 respondents with episodic migraine, approximately half (49.5%) reported high-frequency nausea (i.e., ≥half the time) with headaches. High-frequency nausea was more common in females. Persons with high-frequency nausea, compared with the no/rare or less than half the time nausea groups, reported significantly more headache symptoms and more headache-related impact.

High-frequency migraine-associated nausea is common and is a marker for severe, debilitating migraine. Nausea makes an independent contribution to migraine-associated disability and impact. Management strategies that take nausea into account could reduce the burden of migraines. Nausea is an important target for monitoring and treatment.”

[1] Lipton RB, Buse DC, Saiers J, Fanning KM, Serrano D, Reed ML. Frequency and burden of headache-related nausea: results from the American Migraine Prevalence and Prevention (AMPP) study. Headache. 2013;53(1):93-103.

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Why Migraineurs have nausea even when not experiencing migraine

“Migraineurs may have delayed gastric emptying even when not experiencing migraine, and gastric stasis occurs during migraine attacks. Aurora, S et al

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24-Hour Distribution of Migraine Attacks

Migraine attacks tend to recur in a harmonic 24-hour cyclic manner with a peak around the middle of the day. (Alstadhaug et al., 2007. 24-hour distribution of migraine attacks. Headache 48:95-100)

 

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Veterans Endure Higher Pain Severity than Nonveterans

Data from the National Health Interview Survey shows that American veterans experience a higher prevalence of pain and more severe pain than nonveterans. Although opioids are often prescribed to treat chronic pain, research has not shown them to be very effective, and there are many issues with long-term use. Thus, there is a need for an effective non-narcotic drug to replace the current strategies for pain management and to reduce the need for, and hazards of, excessive reliance on opioids.

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New Migraine Drugs Under Development

New migraine drugs promise relief — but at a steep price,

They’re estimated to cost between $8,000 to $20,000 a year

See the Verge article  By Alessandra Potenza

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We are not a conventional clinical trial site

To be fair! We are not a conventional clinical trial site.
We have been in practice in North Miami for over 30 years, and if may say so ourselves, have a very good reputation. We have thousands of satisfied patients who grew our practice by referring their friend and family members. Additionally, the investigational product we are testing is a combination of two well-known existing drug – not an unknown new entity.

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The burden of headache was highest in females

The 2011 National Health Interview Survey. The burden of headache was highest in females 18-44, where the 3-month prevalence of migraine or severe headache was 26.1% and head pain was the third leading cause of ED visits.

Smitherman TA1, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013 Mar;53(3):427-36

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I’m happy to report: I prescribed zero narcotics in 2017!

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My son, David Shor, found the above chart. The implications of our non-narcotic investigational drug can be far-reaching. This product may provide a safe and effective alternative to opioid painkillers.

 

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