(Headache 2011;51:181‐187)This section of Headache annually reviews the status of recently completed and ongoing clinical trials involving headache disorders. The review will focus on multicenter trials of new therapies as well as novel formulations of previously approved therapeutics. Table 1 summarizes major migraine therapeutic trials that have been completed recently, according to data obtained from the “ClinicalTrials.Gov” website as well as from corporate press releases. Table 2 summarizes the major therapeutic trials that are ongoing at the present time.2010 Completed Clinical Trials in MigraineInvestigational TreatmentMechanism of ActionStudySponsorPhase# SubjectsStart DateEnd DateSumatriptan5‐HT1B receptor agonistAn open‐label study to evaluate the safety of NP101, a sumatriptan iontophoretic transdermal patch, in the treatment of acute migraine over 12 monthsNuPathe Inc.Phase 3300January 2009March‐10 (NDA in November 2010)Dihydroergocryptine inhaled5‐HT1B agonist plus other receptor interactionsA randomized, double blind, placebo controlled, parallel group, Phase 3 study of MAP0004 in adult migraineurs for a single migraine followed by open label extensions to 26/52 weeksMAP Pharmaceuticals, Inc.Phase 3950March 2008November 2010 (completed)Lasmiditan (COL‐144)5‐HT1F agonistDose‐ranging study of oral COL‐144 in acute migraine treatmentCoLucidPhase 2b391July 2009June 2010 (completed)NXN‐1885‐HT1 agonist and nNOS antagonistA Phase 2 study of the safety and effectiveness of a single oral dose of NXN 188 for the treatment of moderate to severe migraine headache with auraNeurAxon Inc.Phase 2300June 2009March 2010 (completed)NXN‐1885‐HT1 agonist and nNOS antagonistPhase 2 study of the safety and effectiveness of a single oral dose of NXN‐188 for the treatment of moderate to severe migraine headache without auraNeurAxon Inc.Phase 2120August 2009March 2010 (completed)NXN‐1885‐HT1 agonist and nNOS antagonistA Phase 2a study of the safety and effectiveness of NXN‐188 for the acute treatment of migraine attacks with auraNeurAxon Inc.Phase 2a40May 2009December 2010 (data pending)LY2590443UnknownA safety, tolerability, and efficacy study of LY2590443 in the treatment of acute migraine headacheEli Lilly and CompanyPhase 2200December 2010April 2010 (terminated)BGC20‐1531EP4 receptor antagonistA multinational, multicenter, randomized, double‐blind, placebo‐controlled, three‐way crossover study in migraine patients, treated with 2 doses of BGC20‐1531 and placeboBTG InternationalPhase 2100June 2009July 2010 (terminated)Prophylactic treatments GSK1838262 (XP13512)GabapentinPrevention study in adult patients suffering from migraine headachesGSK/XenoportPhase 2450August 2008May 2010 (completed) ADX10059mGluR5A Phase 2b, randomized, double‐blind, placebo‐controlled, parallel group, dose‐ranging, multicenter study to investigate the efficacy, safety and tolerability of the mGluR5 negative allosteric modulator ADX10059 for the prevention of migraineAddexPhase 2a350December 2010December 2009 (terminated) Valproate acid (DP‐VPA)NeuromodulatorDouble‐blind, randomized, placebo‐controlled, parallel‐group, two‐arm, multicenter phase ii trial to assess the safety, tolerability, and efficacy of DP‐VPA (up to 900 mg) once daily for 10 weeks in adult subjects with migraineD‐Pharm Ltd.Phase 240July 2008October 2009 (withdrawn before activation) Propranolol LA and topiramateBeta‐adrenergic antagonist and channel antagonistNINDS CRC chronic migraine treatment trialNINCDS, Ortho‐McNeil Janssen Scientific Affairs, LLCPhase 3250October 2008September 2010 (suspended) RamelteonMelatonin agonistA study of a melatonin receptor agonist to prevent migraineSwedish Medical Center|Takeda Global Research & Development Center, Inc.Phase 230April 2008April 2009 (closed) RamelteonHypnoticA double‐blind placebo‐controlled trial of rozerem in migraine headachesTakeda Pharmaceuticals North AmericaPhase 424October 2006July 2009 (closed)NDA, New Drug Application; NINCDS, National Institute of Neurological Disorders and Stroke.2011 Ongoing Clinical Trials in Migraine and Chronic Daily HeadacheInvestigational TreatmentMechanism of ActionStudySponsorPhase# SubjectsStart DateEnd DateAcute treatments MetoclopramideDopamine 2 receptor antagonistMetoclopramide for acute migraine: a dose finding studyMontefiore Medical CenterPhase 3330April 2008May 10 (results pending) Metoclopramide and ketoprofenDopamine 2 receptor antagonist and NSAIDRandomized controlled trial on the effectiveness of metoclopramide alone or in combination with ketoprofen in acute migraine of childIRCCS Burlo GarofoloPhase 3120February 2009June 10, 2010 (results pending) BGG492AMPA antagonistA multicenter, randomized, double‐blind, parallel group, active and placebo controlled, proof of concept study in patients with acute migraine to assess the efficacy, safety and tolerability of single oral doses of BGG492NovartisPhase 275April 2009August 2010 (results pending)Prophylactic treatments Occipital nerve stimulationNeurostimulationPrecision implantable stimulator for migraine study – occipital nerve stimulation for migraineBoston Scientific CorporationPhase 3179February 2006March 2011 Bupivicaine/methylprednisoloneLocal anesthetic and steroidGreater occipital nerve block for migraine prophylaxisMayo ClinicPhase 470June 2009May 2011 DR‐105HormoneA multicenter, randomized, double‐blind study to evaluate the efficacy of DR‐105 compared to placebo for the management of menstrually related migraine headachesTeva Women's HealthPhase 2120November 2008June 2011 TelcagepantCGRP antagonistTelcagepant for prevention of menstrually related migraine in female patients with episodic migraineMerckPhase 34500June 2010September 2011 LY2300559UnknownA randomized, double‐blind, placebo controlled proof of concept study of LY2300559 in patients with migraineEli LillyPhase 2118October 2010April 2012 Cyclobenzaprine hydrochlorideEfficacy and safety of cyclobenzaprine hydrochloride extended release for the treatment of chronic migraineUniversity of Medicine and Dentistry New Jersey|CephalonPhase 370July 2010July 2012 AMPLATZER® PFO Occluder DevicePFO closurePRIMA PFO migraine trialAGA Medical CorporationPhase 2144May 2006January 2013 Candesartan cilexitilCandesartan vs propranolol for migraine preventionUniversity of Science and Technology|AstraZeneca|St. Olavs Hospital|Kragerø Tablettproduksjon as, NorwayPhase 2/372April 2009April 2013 EthosuximideComparison of a drug and placebo in the prevention of migraine headachesDepartment of Veterans Affairs, Thomas Jefferson University, University of PittsburghPhase 2128June 2010October 2013 Occipital nerve stimulationNeurostimulationA prospective, randomized, double‐blind, placebo‐controlled trial of occipital nerve stimulation for drug refractory migraineBoston Scientific CorporationPhase 225May 2006December 2013 DuloxetineJefferson LillyUnknownUnknownUnknownUnknown NXN‐462NeurAxon Inc.Phase 2UnknownJanuary 2011UnknownChronic daily headache OxytocinHormoneEffect of intranasal oxytocin on headache in chronic daily headacheMedVadis Research Corporation/Trigemina, Inc..Phase 280November 2009November 2010AMPA, α‐amino‐3‐hydroxyl‐5‐methyl‐4‐isoxazole‐propionate; CGRP, calcitonin gene‐related peptide; NSAID, non‐steroidal anti‐inflammatory drug; PFO, patent foramen ovale.
