Hitting the Mark in Migraines

By: Marisa Sibley, CCRC

Originally published in the July/August 2017 Issue of Ellis County Living Magazine


I met Laura for the first time in the summer of 2015. She came to my office for her first visit as a volunteer for a clinical research study for migraine headaches. “How are you today?” I asked. “Not great,” she said. “I’ve had a migraine for three days. None of the medications I have used have helped my pain.” As we continued to discuss her condition, she informed me that she experienced a migraine headache nearly 20 days each month. Her condition was debilitating. It hindered her ability to work, to enjoy quality time with her family, and to perform normal, day-to-day tasks.

Laura was far from alone. According to the Migraine Research Foundation, 38 million people in the U.S. suffer from migraine headaches, with three times as many women experiencing symptoms than men. Migraine headaches are more severe than typical headaches. Besides being associated with costly healthcare, the condition also takes an economic toll, costing the U.S. an estimated $13 billion annually. During a migraine attack, an individual experiences pain that throbs or pulses, usually on one side of the head. They typically cause individuals to have sensitivities to lights and sounds, and may even cause blocked vision or dizziness. In addition to the pain, moderate to severe nausea and vomiting are common.  

There are several different over the counter and prescription medications that are approved by the U.S. Food and Drug Administration (FDA) for use by individuals with migraines. These may include non-steroidal anti-inflammatory drugs (NSAIDS), triptans, or other non-migraine treatments. Despite their common use, these treatments are only designed to treat pain after symptoms of a migraine start.

Investigational new treatments that block calcitonin gene-related peptide (CGRP), a protein found in the body to be in high levels during inflammation, are making their way towards likely FDA approval for the treatment of migraine headaches. Treatments of this class are being developed to stop migraines before symptoms start. In clinical trials, these treatments have shown to have positive safety profiles and be effective in reducing the number of days each month an individual experiences a migraine headache.

At ClinPoint Trials, we were able to work with Eli Lilly and Company and patient volunteers from the community on a clinical trial for a treatment called galcunezumab, a CGRP antibody developed to prevent migraine headaches. In a recent press release, Eli Lilly revealed positive results in Phase 3 clinical trials for patients who experienced migraine headaches. These studies compared galcunezumab to placebo, an inactive substance. While the treatment did not completely stop patients from experiencing migraines, those that received it did experience significantly fewer headaches per month compared to patients that received placebo.

“Migraine prevention will be significantly improved with the emergence of treatments such as galcunezumab,” says Dr. Thomas Ledbetter, Principal Investigator at ClinPoint Trials. “While we were blinded to what treatment group the patients were assigned, we had several patients in this study who were so excited to have their migraines finally under control after years of suffering using traditional therapies.”

There is indeed hope for people like Laura that live with migraine headaches and cannot find a treatment that works for them. While it may be a few more years before we see new treatments for migraine headaches receive FDA approval and hit the market for use, we can hold onto hope that we are on the edge of a breakthrough.

From the Lab to Your Medicine Cabinet

Understanding Clinical Trials and the Purpose in Participation

By: Marisa Sibley

Originally published in the May/June 2017 issue of Ellis County LIVING Magazine


When I was a child, I struggled with asthma. To help my condition, my doctor gave me an inhaler that contained a preventative asthma medication. It was easy to use and it helped make physical activities easier for me. I was able to play my favorite sports without fearing I wouldn't be able to breathe. This helped give me a better quality of life as a child. I no longer struggle with asthma, but I am thankful that there was a treatment available to help my condition. 

For me it was an asthma medication and in inhaler. For some it may be insulin or a blood sugar monitor. For others it may simply be an over the counter medication for a common cold or a headache. 

All medications of medical devices available for use by the general population are so only because of individuals who were first willing to volunteer to participate in clinical trials. 

Clinical trials are research studies that seek to answer questions about medical treatments, medical devices or medical strategies. All medical treatments and devices start as ideas. Those ideas are then developed and tested in the laboratory. If the research on these new developments is promising and the Food and Drug Administration (FDA) approves further research testing, then the idea may move forward into clinical trials with human volunteers. 

All potential treatments and devices are tested first in Phase 1 trials, which will only assess whether or not the products are safe for human use. If the products show to be generally safe, then the treatments or devices will continue into Phase 2 and 3 trials with larger numbers of volunteers. These trials continue to answer questions about safety, but also begin to assess how well a product works to improve patient outcomes, if it will benefit a patient, or if the product causes unexpected harm. The FDA monitors and reviews the research data on investigational treatments and devices very closely during all phases of clinical trials and can stop the trials at any time. 

After all trials are completed, the FDA may or may not decide to approve a new treatment or device. Only after FDA approval will these ideas turned treatments end up in our medicine cabinets. Research then continues on these treatments or devices after they enter the marketplace. 

There are many reasons why people choose to participate in clinical trials The top reasons include to advance medicine, to help improve the lives of others, to help improve their own medical condition or to supplement their own standard health care. 

If you choose to join a clinical trial, you can expect to first be thoroughly informed about the study, what the study is testing, information about study appointments and procedures, potential risks and benefits, and your role as a participant.The study doctor, also called an Investigator, will assess whether or not you would be eligible to participate in the study. your eligibility may depend on your medical history, medications you are taking, or other diagnostic tests or exams. 

Throughout the course of your participation in a trial, you can expect your health to be monitored very closely by the Investigator and the study team. This is done through a series of visits to the clinical research site before, during and after a study treatment or device is received or used. Since you are a volunteer, your study-related care is provided free of charge. You may also receive compensation for your time and travel. 

Had no one ever participated in clinical trials for asthma, I may not have had access to a medication that helped my condition improve as a child. Clinical trials are the gateway to advancing medical knowledge and patient care for generations to come. Whether you are a healthy person or have a chronic medical condition, you can help to move medicine forward through participation in a clinical trial. It is truly a gift that keeps on giving. 

If you are interested in participating in a clinical trial in the future or would like more information, reach out to your local clinical research site to speak with a member of the study team about how you can get involved. 


Marisa is a Certified Clinical Research Coordinator (CCRC) at ClinPoint Trials, a clinical research site in Waxahachie. Learn more at www.cptrials.com. You can reach her at (972) 937-1640 or marisas@cptrials.com for more information.

Holiday Highlight

The Christmas season is all about giving.

One of our favorite things about being a part of the Ellis County and Waxahachie community is the willingness of individuals and organizations to offer support to it's fellow neighbors.

Each year, ClinPoint selects a local organization or support service to assist with their missions. We were recently introduced to a local organization called Believing Restoration is Attainable (BRA). Their mission is to "support the ladies" by offering support services to women who are experiencing grief or trauma. These services range from recovery programs like GriefShare and DivorceCare to providing life skills training, professional counseling and transitional services to those that are in need of them. 

The organization hosts an annual holiday party for it's members and their children. Santa makes an appearance and those that attend enjoy a meal and community together. A couple of our staff members were able to attend the event and drop off some goodies for the members of the organization and their families. 

We appreciate this organization's service to the women of Ellis County and Waxahachie, and wish them the best in their vision and mission.

Learn more about Believing Restoration is Attainable here. Follow them on Facebook here

Pictured above:

Members of Believing Restoration is Attainable (BRA) with Sherry Johnson, ClinPoint Trials Owner and Site Director, and Kristen Johnson, Lead Medical Technologist.

Sherry Johnson and BRA Founder Sharon Verigan.