Conflicts of Interest: Dr. Roger Cady currently serves on several advisory boards: Allergan, Astellas, MAP Pharmaceuticals, Merck & Co, Inc., Novartis, Ortho-McNeil Neurologics, and Zogenix. He also receives research grants from Allergan, Boston Scientific, Bristol Myers, GlaxoSmithKline, Merck & Co, Inc., OptiNose, PuraMed Bioscience, and Zogenix. Dr. Cady provided consulting services for Allergan, Astellas, GlaxoSmithKline, Merck & Co., Inc., and Ortho-McNeil Neurologics.
An Exploratory Study of Salivary Calcitonin Gene-Related Peptide Levels Relative to Acute Interventions and Preventative Treatment With OnabotulinumtoxinA in Chronic Migraine
Article first published online: 22 OCT 2013
© 2013 American Headache Society
Headache: The Journal of Head and Face Pain
Volume 54, Issue 2, pages 269–277, February 2014
How to Cite
Cady, R., Turner, I., Dexter, K., Beach, M. E., Cady, R. and Durham, P. (2014), An Exploratory Study of Salivary Calcitonin Gene-Related Peptide Levels Relative to Acute Interventions and Preventative Treatment With OnabotulinumtoxinA in Chronic Migraine. Headache: The Journal of Head and Face Pain, 54: 269–277. doi: 10.1111/head.12250
Dr. Ira Turner has served as a consultant and/or speaker's bureau for Allergan, MAP, Nautilus, Zogenix and has received research support from Allergan.
Dr. Kent Dexter has nothing to disclose.
Ms. M.E. Beach has nothing to disclose.
Mr. Ryan Cady has nothing to disclose.
Dr. Paul Durham has received research support from Allergan.
Trial Registration: ClinicalTrials.gov NCT01071096
Study approved by Sterling IRB.
- Issue published online: 10 FEB 2014
- Article first published online: 22 OCT 2013
- Manuscript Accepted: 10 SEP 2013
- calcitonin gene-related peptide;
- chronic migraine;
- episodic migraine;
- acute treatment
To determine if baseline/interictal saliva calcitonin gene-related peptide (CGRP) levels would be lower in subjects with chronic migraine receiving onabotulinumtoxinA compared with those receiving saline.
CGRP is considered central to the pathogenesis of episodic migraine, but its relationship to chronic migraine is less understood. OnabotulinumtoxinA is an effective treatment for chronic migraine and has been demonstrated to inhibit the vesicular release of CGRP.
This was an exploratory, randomized, placebo-controlled, crossover pilot study of 20 subjects that received onabotulinumtoxinA and saline injection (placebo). The amount of CGRP in saliva samples collected on a nonheadache or low headache day, and prior to and after treatment of a headache exacerbation was measured. Daily headache records, medications, and response to treatment were recorded in a diary.
A decrease in baseline/interictal saliva CGRP levels for subjects receiving onabotulinumtoxinA from 39.4 ± 7.5 pg CGRP/mg total protein after the first month to 25.5 ± 4.1 pg after the third month was observed. However, this difference did not reach significance nor was it significant when compared to the saline treatment. There was a reduction in the number of headache days for both onabotulinumtoxinA and saline over baseline throughout the active phases of the study. However, there was no statistical difference in headache days between groups. Subjects with a greater than 50% response to onabotulinumtoxinA had better 2-hour pain relief with acute treatment than non-responders to onabotulinumtoxinA or saline.
While CGRP levels were not elevated during a migraine attack in chronic migraine subjects as has been reported in episodic migraine, there was an overall decrease in the baseline/interictal levels in response to onabotulinumtoxinA.