Headache: Clinical Trial Finds Oral Atogepant Reduced Monthly Migraine Days

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Dr. Trugman

PainRelief.com Interview with:

Joel M. Trugman, MD
Associate Vice President
Neuroscience Development
AbbVie

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

Response: Migraine is a disabling chronic disease characterized by recurrent headache attacks and associated symptoms, including nausea, phonophobia, or sensitivity to sound, and photophobia, or sensitivity to light.

The ADVANCE clinical trial is a phase 3, randomized, double-blind, placebo-controlled trial and examined the safety and efficacy of atogepant, an oral, small-molecule calcitonin gene-related peptide receptor antagonist in patients with episodic migraine. The primary efficacy endpoint was the change from baseline in mean monthly migraine days (MMD) across the 12-week treatment period. This analysis that was recently published examined the efficacy of atogepant using 4 levels of mean monthly migraine day (MMD) responder rates. 

This analysis found that all doses of atogepant significantly increased the proportion of participants who achieved a ≥25%, ≥50%, ≥75% and 100% reduction in mean monthly migraine days over 12 weeks of treatment.

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More Nonopioid Medications Prescribed for Pain Relief since CDC Released Chronic Pain Guidelines

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PainRelief.com Interview with:

JASON GOLDSTICK
Dr. Goldstick

Jason E. Goldstick, PhD
Injury Prevention Center
Department of Emergency Medicine
University of Michigan, Ann Arbor

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

Response: In 2016, the CDC released the Guideline for Prescribing Opioids for Chronic Pain. A primary goal of this voluntary guideline is that individuals should receive pain management care that provides the greatest overall benefit. Among other things, this may entail beginning opioid treatment only when the clinician determines that the expected benefits outweigh the risks.

Other research has shown reductions in opioid prescribing as reduced since the guideline release; this report examines whether there were changes in nonopioid pain medication prescribing.

Our overall findings were that nonopioid prescribing increased nationally following the guideline release, above and beyond what would’ve been predicted based on the pre-guideline trends, and this finding was generally consistent across patient subpopulations (e.g., those with vs. without prior opioid exposure).

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Study Finds Majority of Hemp Products Mislabeled for CBD and/or THC Content

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PainRelief.com Interview with:
Tory R. Spindle, Ph.D. 
Assistant Professor
Behavioral Pharmacology Research Unit
Department of Psychiatry and Behavioral Sciences 
Johns Hopkins University School of Medicine

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

Due to recent policy changes, hemp products and anything derived from hemp, including non-THC cannabis constituents such as CBD are now federally legal. As a result, CBD products are now available nation-wide, including in states where cannabis remains illegal. Some prior work had shown oral or vaporized cannabinoid products have poor labeling accuracy, but no one had examined the labeling accuracy of topical cannabinoid products, which are a product category growing in popularity. We purchased 105 topical cannabinoid products (e.g., lotions, creams, gels, patches) from national retailers and online. 

We found that the vast majority of the products were inaccurately labeled for CBD and/or THC and that many of the products had health claims on the label that are not recognized by the FDA, the most common of which was pain/inflammation.

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Review of Pain Relief Medications for Back and Neck Pain in Older Adults

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PainRelief.com Interview with:

Michael Perloff, MD PhD Director, Neurology Pain Medicine, Boston Medical Center Assistant Professor, Boston University Medical School
Dr. Perloff

Michael Perloff, MD PhD
Director, Neurology Pain Medicine, Boston Medical Center
Assistant Professor, Boston University Medical School

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

Response: Spine-related pain (low back pain/neck pain) is very common in older adults. Physicians can be reluctant to use pain medications older patients due to reduced liver and kidney function, comorbid medical problems and background polypharmacy. We performed an extensive review of the medical literature with a focus on double-blind, placebo controlled, clinical trials.

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Study Highlights Challenges of Opioid Use Disorder in Patients with Cancer Pain

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PainRelief.com Interview with:
Katie Fitzgerald Jones MSN, APN
PhD candidate Connell School of Nursing
Boston College
Jonas Mental Health Scholar 2021-2023
American Academy of Nursing Jonas Policy Scholar 
Ruth L. Kirschstein National Service Award (F31NR019929-01)

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

Response: I am a Palliative and Addiction Nurse Practitioner at VA Boston and a Ph.D. candidate at Boston College Connell School of Nursing. In my clinical practice, I regularly care for people with cancer who have a co-occurring substance use disorder. 

How to best care for people with substance use disorders, such as opioid use disorder is especially complex in people with cancer because opioid management is a standard of cancer-pain management and cancer prognoses can influence opioid decisions and vary. It is important when prescribing opioids that you attend to safety while also addressing pain. People with untreated opioid use disorder or concerning opioid behaviors (such as taking more opioids than prescribed or using opioids with unprescribed medications that increase the risk for opioid-related harm such as benzodiazepines) have an increased risk for opioid related-harms. It is also an area that lacks consensus and is absent from cancer-specific pain guidelines.

This study was conducted with leaders in palliative care including senior author, Jessica Merlin to tackle the question of what is consensus among palliative care and addiction clinicians to caring for people with opioid misuse or use disorder and cancer-related pain and how this is influenced by prognosis?

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Study Reports on Adolescent Headaches During Covid Restrictions

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PainRelief.com Interview with:
Dr Ayşe Nur Özdag Acarli
Ermenek State Hospital, Karaman, Turkey

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

Response: Headache is the most common neurological problem in children and adolescents. Various factors can contribute to headache such as school, sleep, physical activity, electronic devices, mental health problems and socioeconomic conditions.

For young people, the COVID-19 pandemic has had a striking change on every aspect of life such as school closure, online education from home, fewer academic pressures, more self care at home. Early studies, examined shorter-term effects of the pandemic, reported a reduction on the prevalence of headache and chronic pain in adolescents during COVID-19, which was attributed to less school-related stress. However, in my personal clinical experience, young patients suffered more frequent and severe headaches during the pandemic, especially after the first year of the pandemic. However, literature has been lacking in the long term effects of the pandemic on headache in adolescents.

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PTSD: Cognitive Behavioral Therapy for Pain Relief from PostTraumatic Headache

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PainRelief.com Interview with:
Don McGeary, PhD, ABPP
Vice Chair for Research, Rehab Medicine
Associate Professor, Rehab and Psychiatry
UT Health San Antonio

Don McGeary
Dr. McGeary

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

Response: This was a randomized clinical trial funded as part of the Consortium to Alleviate PTSD.  The primary aim of the study was to test the efficacy of a novel non-pharmacological intervention (called CBT for headache; CBTH) for posttraumatic headache (PTH) attributable to mild traumatic brain injury (mTBI). 

PTH is the most common and disabling consequence of mild traumatic brain injury and is a large concern for military service members and veterans in the post-9/11 deployment era because of the significant increase in head injury in this population over the last 20 years.  Posttraumatic headache has been recognized under various labels (including “shell shock” and “hero’s headache”) for over a century, but there are no proven, frontline treatments for PTH. PTH is unique among headache diagnoses because it is classified as a secondary headache (i.e., develops as a consequence of another medical phenomenon, mTBI) and because it is diagnosed based on the injury that led to the headache with no criteria for specific clinical characteristics.  Thus, the “phenotype” of posttraumatic headache is variable with the most frequent reports describing symptoms consistent with migraine AND tension type headaches. 

Unfortunately, because the underlying mechanisms of PTH differ from the primary headaches they resemble, frontline medications (abortive and prophylactic) may not have the same efficacy for PTH as they do for the primary headaches for which they are usually prescribed.  To complicate things further, PTH is often acquired in the context of a traumatic experience (blast, firearms overpressure, motor vehicle accident, other traumatic injury), so PTSD is highly comorbid with these headaches and there is an evolving body of research showing that PTSD can complicate, maintain and worsen pain.

Thus, our study sought to
(1) Test a novel non-pharmacological intervention tailored to PTH rehabilitation and
(2) Assess the relationship between PTSD and PTH to determine if preferred treatment pathways should include PTSD treatment as well. 

This resulted in a three-arm trial comparing CBTH to a gold-standard non-pharmacological treatment for PTSD and usual care in a large VA polytrauma center.

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Relivion Stimulator of Both Occipital and Trigeminal Nerves for Migraine Pain Relief

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PainRelief.com Interview with:
Oved Daniel MD
Headache and Facial Pain Clinic
Ramat-Aviv Medical Center
President of the Israeli Headache Association
Tel-Aviv, Israel

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

Response: Migraine patients experience disabling symptoms, which often left untreated or exasperated by currently available therapies, therefore, a significant unmet medical need for treating migraine pain remains.

Current external nerve stimulation devices only target one nerve and this study assessed the safety and performance of a new external nerve stimulation device that stimulates the two major nerve branches associate with pain (occipital and trigeminal) .

The Relivion MG is a non-invasive device that the patient can wear at home to treat their migraine pain and associate symptoms.

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Preclinical Trial Tests Combination of CBD:THC for Migraine Relief

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PainRelief.com Interview with:
Andrew F. Russo, Ph.D.
Professor, Dept. Molecular Physiology and Biophysics
University of Iowa
Iowa City, IA 52242

Dr. Russo

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

Response: The company Schedule 1 Therapeutics approached us with an interest in testing a combination of CBD:THC in migraine. We thought the topic had tremendous public interest so we teamed up with them and won grants from the Migraine Research Foundation and from the National Institute on Drug Abuse.  

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Experimental Hydrogel Improved Chronic Pain from Degenerative Disc Disease

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PainRelief.com Interview with:
Douglas P. Beall, MD, FSIR
Chief of Radiology Services
Clinical Radiology of Oklahoma

Dr. Bealll

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

Response: Degenerative disc disease (DDD) is the leading cause of chronic low back pain and one of the world’s most common medical conditions contributing to high medical and disability costs. Healthy spinal discs act aids spine movement and distributes force which allows for spine flexibility and even distribution of the load that is placed on the spine. Each has a firm outer layer and a soft, jelly-like core. With normal aging, discs tend to become dry, thin, cracked or torn, which can cause pain and abnormal motion.

Substances called hydrogels, with biochemical similarities to the intervertebral disc designed to augment both the core and outer layer, have been used for years to help repair degenerated discs. First-generation hydrogels are placed as a soft solid, through a surgical incision, but were not simple to place and had a tendency to migrate from where they were originally placed.

For a first-in-human trial, our team conducted a prospective, single-arm feasibility study to evaluate an experimental, injectable hydrogel for safety and performance in relieving chronic low back pain caused by DDD. We used a second-generation hydrogel (Hydrafil™) developed by ReGelTec, Inc.. Unlike earlier hydrogels, it can be temporarily modified into a liquid and injected rather than placed through a small incision. In 2020, this product received FDA’s breakthrough device designation, allowing expedited review based on promising early evidence.

We recruited 20 patients, aged 22 to 69, who each described their pain as four or higher on a zero to 10 scale. None had found more than mild relief from non-surgical management, which includes rest, analgesics, physical therapy, and back braces. Patients were sedated for the procedure, and the gel was heated to become a thick liquid. Guided by fluoroscopic imaging, an interventional radiologist used a 17-gauge needle to inject the gel directly into the affected disc(s). The gel filled in cracks and tears and adhered to the disc’s core and outer layer.

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