Sheena Aurora Discusses the PREEMPT 1 Trial for Chronic Migraine

Fast Breaking Papers Commentary, August 2011

Sheena Aurora
Sheena Aurora's PREEMPT Team. Front to back: Sheena Aurora, MD; Patricia Barrodale, RN; Reda Tipton, CCRC; Danna Caceres-Reyes, Adel Islam.

Article: OnabotulinumtoxinA for treatment of chronic migraine: Results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial

Authors: Aurora, SK;Dodick, DW;Turkel, CC;DeGryse, RE;Silberstein, SD;Lipton, RB;Diener, HC;Brin, MF;PREEMPT 1 Chronic Migraine
Journal: CEPHALALGIA, Volume: 30, Issue: 7, Page: 793-803, Year: JUL 2010
* Swedish Pain & Headache Ctr, 1101 Madison St,Suite 200, Seattle, WA 98104 USA.
* Mayo Clin Arizona, Phoenix, AZ USA.
* Thomas Jefferson Univ, Philadelphia, PA 19107 USA.
(Addresses have been truncated)
(Commentary for June 2011 [late entry])

Sheena Aurora talks with and answers a few questions about this month's Fast Breaking Paper paper in the field of Neuroscience & Behavior.

SW: Why do you think your paper is highly cited?

Chronic migraine sufferers (patients who have headache =15 days/month) have high disability and low quality of life, and are often refractory to the currently available treatment options. Prior to these studies, this patient population was excluded from most acute and preventive migraine trials. This paper describes the results of the first of two large-scale, phase 3 double-blind and placebo-controlled clinical trials (PREEMPT; Phase III REsearch Evaluating Migraine Prophylaxis Therapy).

PREEMPT demonstrated efficacy of onabotulinumtoxinA in the prophylactic treatment of headaches in chronic migraine patients. These results generated quite a bit of interest among headache specialists and neurologists because they have practical implications for chronic migraine patients, who are in need of efficacious treatment options.

SW: Does it describe a new discovery, methodology, or synthesis of knowledge?

The PREEMPT trials are the first of their kind. Prior to PREEMPT, there were no clinical trial guidelines for the chronic migraine population. Therefore, the investigators of PREEMPT designed the trial to assess multiple headache symptoms, including measures of headache impact and quality of life. These studies were conducted over a 15-month trial period where a daily telephone diary was used to capture safety and efficacy data.

"If we are able to reduce disability and decrease migraine frequency and severity, it will improve not only the lives of individual patients but also those around them."

By including all of these variables, PREEMPT demonstrated statistically significant and clinically meaningful improvements with onabotulinumtoxinA treatment over placebo treatment in this patient population. In addition, the PREEMPT clinical program used a novel, standardized treatment paradigm that was designed to target the nerves in the face, head, and neck that are integral to the development of chronic migraine.

SW: Would you summarize the significance of your paper in layman's terms?

This study demonstrated that injection of onabotulinumtoxinA into the head and neck muscles of chronic migraine patients produced clinically and statistically significant reductions in multiple headache symptoms (i.e., headache day frequency, severity of headache, and duration of headache) and improvements in quality of life. Importantly, this study showed that onabotulinumtoxinA is an effective treatment option among this highly disabled patient population.

SW: How did you become involved in this research, and how would you describe the particular challenges, setbacks, and successes that you've encountered along the way?

I got involved in migraine research during my fellowship training with Michael Welch, who had the first NIH-funded program project grant in migraine. Under his strong leadership we were able to make important contributions to the literature, i.e., physiologically prove that the migraine brain is hyperexcitable. One of our studies demonstrated a spectrum in chronic migraine using functional MRI and then later PET and TMS studies. The challenge is the ability to replicate these studies and continue to have a strong team with an interest in migraine as well as funding.

SW: Where do you see your research leading in the future?

We hope to continue to study migraine using different technologies and to discover biomarkers that will help and guide our therapy. It is also our hope to continue our collaborations with the pharmaceutical and biotechnology industry to identify new targets and molecules with the potential to help migraine sufferers.

SW: Do you foresee any social or political implications for your research?

Migraine, especially chronic migraine, has a huge impact on society. Not only for the sufferers themselves, but also for their coworkers and family members. According to epidemiological surveys, 1 in every 4 households has one migraine sufferer. If we are able to reduce disability and decrease migraine frequency and severity, it will improve not only the lives of individual patients but also those around them.End

Sheena K. Aurora, M.D.
Swedish Headache Center
Seattle, WA, USA




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