The PACAP Receptor: A Novel Target for Migraine Treatment
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1 DEPARTMENT OF NEUROLOGY D A N I& S DANISH H H E AHEADACHE D A C H E CENTER C E N T E R Faculty of Health and Medical Sciences The PACAP Receptor: A Novel Target for Migraine Treatment Messoud Ashina, MD, PhD, DMSc Professor of Neurology Rigshospitalet Glostrup Glostrup Hospital, the Capital Region of Denmark
2 Disclosures Personal fees from Alder BioPharmaceuticals, Allergan, Amgen, Autonomic Technologies Inc. (ATI), and Eli Lilly Principal investigator for Amgen trials , , , and , and GM-11 gammacore -R trial
3 PACAP belongs to the secretin/glucagon/vasoactive intestinal polypeptide (VIP) family Arimura et al. Jpn J Physiol. 1998
4 CNS and PNS Neurotransmission, neuromodulation, regulation of cicardian clock, behavioral actions, learning and memory procession Immune system Regulation of immune reponses Vascular system Vasodilation Endocrine system Regulation of pituitary, adrenal and pacreatic secretion PACAP38 VIP Gastrointestinal system Regulator of lipid/carbohydrate mebolism, liver cell proliferation Urogenital system Regulation of micturation pathways Respiratory system Bronchodilation Vaudry et al. Pharmacol Rev Diané et al., J Metabolic Synd 2014
5 Pain-sensitive structures Wolff 1963 Olesen et al, Lancet Neurology 2009
6 What triggers migraines? DANISH HEADACHE CENTER
7 Human model of migraine PACAP & VIP Modified from Olesen et al. Cephalalgia 2009
8 Headache intensity (VRS) VIP min hours PACAP38 Migraine-like attacks (7/12) Schytz et al. Brain 2009 VIP Migraine-like attacks (n=0/12) Rahmann et al. Cephalalgia 2008 Headache intensity (VRS) PACAP min hours
9 STUDY DESIGN MEASUREMENTS STUDY FLOW CHART Double blind randomized crossover study Baseline Clinical data Headache interviews Migraine symptoms Other symptoms Recruited (n=34) Infusion PACAP38 / VIP In-hospital phase (0-5 h) Post-hospital phase (6-24 h) Physiological data Heart rate Blood pressure Respiratory freq. End-tidal CO2 pressure Biochemical data Plasma PACAP38 conc. Plasma VIP conc. Plasma tryptase conc. Neuroimaging data MR-angiography Functional MRI Anatomical MRI MR-venography Drop outs (n=10) Drop outs (n=2) Included (n=24) Completed (n=22)
10 Headache/migraine after PACAP38 and VIP % 73% 82% Headache Migraine PACAP VIP 18% Intravenous PACAP38 (10 pmol/kg/min) infusion over 20 min Amin et al, Brain 2014
11 MRI angiography Baseline PACAP-38 2 hours after Amin et al., Brain 2014
12 An axial view of a 3D reconstruction of the time-of-flight MR-angiography scan A B Before (A) and after (B) subcutaneous injection of 6 mg sumatriptan, showing marked extracranial vasoconstriction Amin et al., Brain 2014
13 Resting-state state functional connectivity MRI
14 Resting-state state functional connectivity MRI PACAP-38 Amin et al., Neurology 2016
15
16 PACAP38-induced migraine attacks Salience Network Sensorimotor Network Default Mode Network INCREASED CONNECTIVITY INCREASED CONNECTIVITY INCREASED CONNECTIVITY R+L inferior frontal gyrus R premotor cortex L primary auditory cortex L somatosensory cortex II L premotor cortex L visual cortex V4 DECREASED CONNECTIVITY Cognitive functions None Emotions Speech/language Working memory DECREASED CONNECTIVITY Motor function in face L visual cortex V1, V2, V3 Cognitive affected Photophobia DECREASED CONNECTIVITY Phono/photophobia R frontal lobe R cerebellum Pain perception Cognitive functions Pain modulation Amin et al., Neurology 2016
17 Conclusions PACAP38 induced more migraine than VIP PACAP38-induces marked dilation of extracerebral arteries blocked by sumatriptan The pre-ictal phase is associated with change of functional connectivity of core brain networks
18 PACAP38 induced migraine No migraine 25 % Migraine 75 % Genetics? Biochemical markers? CGRP TNF alfa Schytz et al. Brain 2009; Amin et al. Brain 2014 Premonitory symptoms?
19 Migraine after PACAP38 infusion Guo et al., Cephalalgia 2016
20 Attack (n=23) No attacks (n=9) PACAP38 P=0.363 VIP P=0.819 CGRP P=0.792 TNFa P=0.448 Guo et al., Cephalalgia 2016
21 Results PACAP38 11 out of 23 patients (48%) with induced attack had PS after PACAP Guo et al., Cephalalgia 2016
22 Conclusions Familial predisposition has no effect on migraine response Changes in plasma CGRP or TNF alfa have no effect on migraine response PACAP38 induces premonitory symptoms in 48% of patients
23 PACAP & VIP receptors PACAP38 has 1000 times higher affinity for the PAC 1 -R than VIP Drug target? Dickinson & Fleetwood-Walker. TIPS 1999
24
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