LOS ANGELES—Three new experimental treatments targeting calcitonin gene-related peptide (CGRP) receptors for the prevention or reduction of migraine have shown promise in preventing migraine attacks, according to researchers. The new treatments—AMG 334, LY2951742, and ALD403—are selective and potent antibodies targeting human CGRP biology with the potential for migraine prevention.
AMG 334 is an investigational human antibody that targets the CGRP receptor rather than CGRP itself. AMG 334 is in phase II clinical trials for the prevention of migraines. In prior studies of AMG 334 in nonhuman primates, the therapy was found to be a “potent and selective antibody against the human CGRP receptor with potential for migraine prevention,” the authors said.
In the LY2951742 study, 217 subjects with four to 14 migraine headache days per month received biweekly subcutaneous injections of either LY2951742 (a monoclonal antibody that binds to CGRP) or placebo for a total of as many as six doses in a 12-week treatment period. Compared with placebo, treatment with LY2951742 resulted in a significantly greater decrease from baseline in the last 28-day period in the number of migraine headache days, migraine attacks, headache days, and combined probable migraine and migraine headache days. In addition, significantly more patients treated with LY2951742 had a greater than 50% reduction in the last 28-day period in the number of migraine headache days, compared with placebo.
In the ALD403 study, ALD403 was given as a single IV infusion to 81 patients; 82 patients received placebo. Patients were followed for 12 weeks. At the end of 12 weeks, there was, on average, a 66% decrease in migraine days in the ALD403-treated subjects versus a 52% decrease for placebo-treated patients. ALD403 treatment resulted in 16% (0% for placebo) of patients having no migraines, 32% (9% for placebo) of patients having a 75% decrease in their migraine days, and 60% (33% for placebo) having a 50% decrease in their migraine days for the full 12-week study period.
All three CGRP monoclonal antibody treatments were well tolerated and showed no significant adverse events or other safety concerns.
Peter Goadsby, MD, of the University of California, San Francisco, and coinvestigator on two of the CGRP monoclonal antibody studies, stressed that the findings in all three studies are encouraging but preliminary and need larger, longer-term studies to confirm the efficacy and safety of the treatments.
Deployment-Related Brain Injury Is Strongly Associated With Migraine in Iraq and Afghanistan Veterans
Veterans who were deployed to combat zones in the Iraq and Afghanistan wars and experienced traumatic brain injury (TBI) have a strong and highly significant increase in the frequency and intensity of headaches, the majority of which are migraines, according to researchers.
The incidence of chronic daily headache (ie, 15 or more headache days per month) was three times greater, compared with controls, and the incidence of frequent headache (ie, 10 to 14 headache days per month) was 4.5 times greater in these soldiers than in control groups, reported lead author James R. Couch, MD, of the University of Oklahoma School of Medicine in Oklahoma City, and colleagues. “Combat zone deployment by itself is stressful. Since TBI is the signature injury of these wars and occurs in 15% to 20% of deployed soldiers, and both TBI and stress are known to be associated with headache, we sought to evaluate the differences in headache occurrence and severity between those who were deployed and those who were deployed and also experienced a TBI,” Dr. Couch said.
Dr. Couch and his team evaluated 53 pairs of deployed veterans with TBI and a matched group of veterans who were deployed but did not sustain a TBI (controls). All subjects with deployment-related TBI had headache, while 11 (23.9%) controls had no headache. In addition, 89% of headaches in the deployed veterans with TBI were migraine, compared with 40% in the control group. All subjects with deployment-related TBI reported significantly greater frequency and intensity of headache than the control group did.
Adolescents With Chronic Migraine Get More Relief When Their Medications Are Combined With Biofeedback and Relaxation Therapies
Cognitive behavioral therapy (CBT) resulted in greater reductions in headache frequency and migraine-related disability in children and adolescents with chronic migraine, according to researchers.
The study, conducted by Scott W. Powers, PhD, and his team at Cincinnati Children’s Hospital Medical Center found that adding biofeedback, relaxation techniques, and stress reduction to amitriptyline therapy reduced the number of migraine days and disability and had a favorable and clinically meaningful impact on children’s school functioning.
“Now that there is strong evidence for CBT in headache management, we believe it should be offered routinely as a first-line treatment for chronic migraine along with medications, and not only as an add-on if medications are not found to be sufficiently effective,” said Dr. Powers.