Migraine: Galcanezumab (Emgality®) for Pain Relief in Patients with Previous Preventive Medication Failures

PainRelief.com Interview with:
Dulanji K. Kuruppu, MD

Medical Advisor, Migraine & Headache Disorders
US Medical Affairs
Eli Lilly and Company
LTC-South, Indianapolis IN 46221 U.S.A.

PainRelief.com:  What is the background for this study?

Response: Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) and is approved for the preventive treatment of migraine and for the treatment of episodic cluster headache in adults. The CONQUER study assessed the efficacy and safety of galcanezumab in 462 adults with episodic or chronic migraine who previously did not benefit from 2 to 4 standard-of-care migraine preventive medication categories. This study consisted of a 3-month double-blind, placebo-controlled period (months 1-3) followed by an open-label period (months 4-6). The primary endpoint, which was the mean change from baseline in the number of monthly migraine headache days for galcanezumab vs placebo over months 1-3, was met. In this post-hoc analysis, we assessed onset of effect of galcanezumab in the CONQUER population.

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Aimovig® plus OnabotulinumtoxinA (onabot) For Migraine Pain Relief

PainRelief.com Interview with:
Fred Cohen, MD
Department of Medicine, 
Montefiore Medical Center and the Albert Einstein College of Medicine
Bronx, New York

Dr. Fred Cohen

PainRelief.com:  What is the background for this study?

Response: OnabotulinumtoxinA (onabot) and calcitonin gene-related peptide monoclonal antibodies (CGRP-targeted mAbs) are two medications used to treat chronic migraine. While both have been shown to significantly reduce monthly headache days, they are some patients that require further treatment after receiving one of these therapies. Prior to this study, there was limited data on the efficacy and safety of concomitant treatment with onabot and a CGRP-targeted mAb. 

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Mindfulness Meditation for Migraine Pain Relief

PainRelief.com Interview with:
Rebecca Erwin Wells, MD, MPH
Associate Professor, Department of Neurology
UCNS Certified Headache Specialist
Founder and Director of the Comprehensive Headache Program at Wake Forest Baptist
Wake Forest School of Medicine

PainRelief.com: What is the background for this study?

  • Migraine is the second leading cause of disability worldwide.
  • Many patients with migraine stop medications because of side effects or ineffectiveness.
  • Many patients with migraine still use opioids despite recommendations against them for headache treatment. 
  • Mindfulness is helpful for many clinical pain conditions.
  • We conducted a pilot study of mindfulness for migraine that demonstrated benefit, so we conducted this larger randomized controlled trial to understand further potential benefit.
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Mindfulness-Based Stress Reduction Can Provide Pain Relief from Episodic Migraine

PainRelief.com Interview with:
Neda Gould, PhD
Assistant Professor
Director, Mindfulness Program at Johns Hopkins
Associate Director, Bayview Anxiety Disorders Clinic
Department of Psychiatry and Behavioral Sciences
Johns Hopkins School of Medicine

PainRelief.com:  What is the background for this study?

Response: Migraines can be severe and debilitating and many of the current pharmacological treatments have side effects. We were interested in studying the effect of a non-pharmacological intervention (mindfulness meditation) on migraines using various outcomes including brain imaging.

Mindfulness-Based Stress Reduction (MBSR) is a program that has been shown to improve chronic pain. However, the benefits of this program have been modest in migraine patients. We sought to determine if a longer period of mindfulness training and home practice would yield better outcomes in migraine patients.

The traditional MBSR course consists of 8 weekly sessions and a retreat. We enhanced this course to include the 8 weekly sessions and retreat followed by 4 additional biweekly sessions (MBSR +).

We randomized 98 adults with episodic migraine to the MBSR+ group (50 participants) or to a stress management for headache group (SMH, 48 participants). The SMH group included didactic content on stress and other triggers in headaches. Both groups followed a similar format and timing.

All participants completed questionnaires an also underwent magnetic resonance imaging (MRI) to look at changes in brain structure and function.

Genetic Differences Distinguish Episodic Versus Chronic Migraine and May Open New Avenues of Pain Relief

PainRelief.com Interview with:
Aliya Yakubova MD
OpenLab “Gene and Cell Technologies”
Institute of Fundamental Medicine, Kazan Federal University
Kazan, Russia

Dr. Yakubova

PainRelief.com:  What is the background for this study?

Response: Migraine is a common debilitating primary headache disorder with strong socio-economic effects. According to some estimates, migraine is the most costly neurological disease: for example, in the European Union, it costs more than 27 billion euros a year.

In this regard, chronic type of migraine (with more than 15 attacks per month for more than three months) is of special interest. Because of high prevalence and the burden of attacks, it is of great importance to improve diagnostic tools for patient stratification and choosing appropriate treatment strategies of migraine. For this purpose we investigated contribution of transient receptor potential vanilloid type 1 (TRPV1) receptors to migraine chronification. It is known that these receptors are directly involved in the disease pathogenesis being associated with the release of the key migraine pain mediator, the calcitonin gene – related peptide (CGRP). Moreover, recent studies have suggested that the non-synonymous TRPV1 single-nucleotide polymorphism (SNP) 1911A> G (rs8065080), resulting to the substitution of amino acids isoleucine to valine in the protein structure of receptor (Ile585Val), influences functional activity of these receptors in neuropathic pain syndromes. All this together was the starting point of our research in collaboration with colleagues from the University of Eastern Finland.

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Opioids Frequently Prescribed For Headache Pain Relief

PainRelief.com Interview with:
Richard B. Lipton, M.D.
Professor, The Saul R. Korey Department of Neurology
Professor, Department of Psychiatry and Behavioral Sciences
Professor, Department of Epidemiology & Population Health
Edwin S. Lowe Chair in Neurology
Vice Chair The Saul R. Korey Department of Neurology
Director, Montefiore Headache Center
Albert Einstein College of Medicine

PainRelief.com:  What is the background for this study

Response: Almost everyone with migraine takes acute treatments at the time of attacks to relieve pain and restore function.  Acute treatments include over-the-counter medications. prescription drugs and devices.  The most widely used prescription drugs for migraine are triptans (such as sumatriptan and rizatriptan) and NSAIDs (such as ibuprofen and naproxen). 

Richard B. Lipton, M.D. Professor, The Saul R. Korey Department of Neurology Professor, Department of Psychiatry and Behavioral Sciences Professor, Department of Epidemiology & Population Health Edwin S. Lowe Chair in Neurology Vice Chair The Saul R. Korey Department of Neurology Director, Montefiore Headache Center Albert Einstein College of Medicine
Dr. Lipton

Opioids are not recommended in treatment guidelines as acute treatments for migraine.  Longitudinal studies show that in people with migraine treatment with opioids is associated with dose dependent acceleration of headache frequency and the development of chronic migraine in people with episodic migraine.  The purpose of this study was to determine the relative frequency of opioid use and the characteristics of those who use opioids to treat migraine. The hope is to use this information to develop programs which will encourage guideline compliant treatment.

Acupuncture for Migraine Pain Relief

PainRelief.com Interview with:

Prof. Wei Wang
Department of Neurology,
Tongji Hospital, Tongji Medical College,
Huazhong University of Science and Technology,
Wuhan, Hubei, P.R. China

acupuncture

PainRelief.com:  What is the background for this study?

Response: The burden of migraine is substantial, resulting in considerable economic and social losses. The latest Global Burden of Disease Study showed that 1.25 billion people had migraine in 2017. A significant number of patients are still not responding well to drug therapy, or cannot tolerate the adverse effects of drugs, or have contraindications, which can lead to low medication compliance, headache chronification and acute medication overuse. Prophylactic drugs should be recommended for migraineurs who have at least four headache days per month, but only 13% of patients reported current use of preventive drugs. Besides, ineffectiveness of and/or contraindications to migraine medication affect 10-15% of people with migraine. Hence, a need exists to investigate non-drug interventions.

Previous studies suggest that acupuncture works particularly well on a range of pain disorders. However, clinical evidence for the benefit of manual acupuncture for migraine prophylaxis remains scarce. Appropriate placebo control settings and successful blinding are two critical elements in addressing this challenge. Sham acupuncture involving penetrating needles should be avoided in clinical trials. Previous acupuncture research has often used penetrating sham acupuncture, involving needling non-acupuncture points, needling irrelevant acupuncture points, or superficial needling. However, whether the needle is inserted into an acupuncture point or a non-acupuncture point, it could produce a physiological effect. Comparisons between true acupuncture and sham acupuncture might also be biased by unsuccessful blinding. To ensure an inert placebo control and successful blinding, we recruited acupuncture-naive patients, using non-penetrating sham acupuncture at heterosegmental non-acupuncture points as the control, and designed the same procedures to perform the same rituals as much as possible in the manual and sham acupuncture groups.

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Migraine: Aspirin Evaluated for Pain Relief and Prevention

PainRelief.com Interview with:

Charles Hennekens, MD, DrPH

Prof. Hennekens

Sir Richard Doll Professor
Senior Academic Advisor to the Dean
Charles E. Schmidt College of Medicine
Florida Atlantic University

PainRelief.com:  What is the background for this study?

Response: Migraine headaches are among the most common and potentially debilitating disorders encountered by primary healthcare providers. In the treatment of acute migraine as well as prevention of recurrent attacks there are prescription drugs of proven benefit. For those without health insurance or high co-pays, however, they may be neither available nor affordable and, for all patients, they may be either poorly tolerated or contraindicated. 

Migraine: Pain Relief from BotoxA May Last At Least 6 Months After Injections Stopped

PainRelief.com Interview with:
Jason Ching MD
Department of Neurology
George Washington University School of Medicine
Washington, DC

headache migraine

PainRelief.com:  What is the background for this study?  What are the main findings?

Response: The clinical course of chronic migraine patients who respond positively to serial botulinum toxin A (BotoxA) injection therapy and eventually discontinue treatment has not been well-studied. Optimizing the duration of treatment would be beneficial from both a cost and safety perspective.

In our study, we found that over 80% of our chronic migraine patients who achieved our stipulated stopping rule experienced no clinical worsening or associated need to resume prophylactic therapy for at least 6 months following discontinuation of BotoxA.

A greater number of BotoxA treatments required to achieve the stopping rule and the presence of baseline chronic daily headaches for over 6 months duration were factors correlated with clinical deterioration.

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Migraine Linked to Poor Sleep and Sleep Apnea

PainRelief.com Interview with:

Dawn C. Buse PhD
 Clinical Professor of Neurology
 Albert Einstein College of Medicine
 New York City

Dawn C. Buse PhD
Clinical Professor of Neurology
Albert Einstein College of Medicine
New York City

PainRelief.com:  What is the background for this study?

Response: Sleep is essential in the regulation of a wide range of homeostatic functions.  Dysregulation of sleep process may be triggers for migraine attacks and increase the risk of migraine disease chronification.  Migraine is comorbid with a range of medical, neurologic, and psychiatric comorbidities that may exacerbate the disease, complicate treatment, and reduce health-related quality of life.  These comorbidities include sleep disorders such as sleep apnea, insomnia, circadian rhythm (i.e., sleep-wake) disorders, and sleep movement disorders.

The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study is a longitudinal study that used a series of web-based surveys over 15 months to assess migraine symptoms, burden and patterns of healthcare utilization among people in the US population.  Validated questionnaires were used to assess many comorbidities.  Migraine can be classified based on the number of headache days per month into episodic migraine (<15 headache days/month) and chronic migraine (≥15 headache days/month).

In this cross-sectional analysis of data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study, we assessed sleep apnea and poor sleep quality in a US population based sample of 12,810 people with migraine.  Respondents were stratified by episodic (11,699) and chronic (1,111) migraine and by body mass index (BMI).