2010: Year in Review
Authors: Peroutka Stephen J. 
Published: January 2011

(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 Migraine

Investigational Treatment
Mechanism of Action
Study
Sponsor
Phase
# Subjects
Start Date
End Date

Sumatriptan
5‐HT1B receptor agonist
An open‐label study to evaluate the safety of NP101, a sumatriptan iontophoretic transdermal patch, in the treatment of acute migraine over 12 months
NuPathe Inc.
Phase 3
300
January 2009
March‐10 (NDA in November 2010)

Dihydroergocryptine inhaled
5‐HT1B agonist plus other receptor interactions
A 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 weeks
MAP Pharmaceuticals, Inc.
Phase 3
950
March 2008
November 2010 (completed)

Lasmiditan (COL‐144)
5‐HT1F agonist
Dose‐ranging study of oral COL‐144 in acute migraine treatment
CoLucid
Phase 2b
391
July 2009
June 2010 (completed)

NXN‐188
5‐HT1 agonist and nNOS antagonist
A 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 aura
NeurAxon Inc.
Phase 2
300
June 2009
March 2010 (completed)

NXN‐188
5‐HT1 agonist and nNOS antagonist
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 without aura
NeurAxon Inc.
Phase 2
120
August 2009
March 2010 (completed)

NXN‐188
5‐HT1 agonist and nNOS antagonist
A Phase 2a study of the safety and effectiveness of NXN‐188 for the acute treatment of migraine attacks with aura
NeurAxon Inc.
Phase 2a
40
May 2009
December 2010 (data pending)

LY2590443
Unknown
A safety, tolerability, and efficacy study of LY2590443 in the treatment of acute migraine headache
Eli Lilly and Company
Phase 2
200
December 2010
April 2010 (terminated)

BGC20‐1531
EP4 receptor antagonist
A multinational, multicenter, randomized, double‐blind, placebo‐controlled, three‐way crossover study in migraine patients, treated with 2 doses of BGC20‐1531 and placebo
BTG International
Phase 2
100
June 2009
July 2010 (terminated)

Prophylactic treatments

 GSK1838262 (XP13512)
Gabapentin
Prevention study in adult patients suffering from migraine headaches
GSK/Xenoport
Phase 2
450
August 2008
May 2010 (completed)

 ADX10059
mGluR5
A 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 migraine
Addex
Phase 2a
350
December 2010
December 2009 (terminated)

 Valproate acid (DP‐VPA)
Neuromodulator
Double‐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 migraine
D‐Pharm Ltd.
Phase 2
40
July 2008
October 2009 (withdrawn before activation)

 Propranolol LA and topiramate
Beta‐adrenergic antagonist and channel antagonist
NINDS CRC chronic migraine treatment trial
NINCDS, Ortho‐McNeil Janssen Scientific Affairs, LLC
Phase 3
250
October 2008
September 2010 (suspended)

 Ramelteon
Melatonin agonist
A study of a melatonin receptor agonist to prevent migraine
Swedish Medical Center|Takeda Global Research & Development Center, Inc.
Phase 2
30
April 2008
April 2009 (closed)

 Ramelteon
Hypnotic
A double‐blind placebo‐controlled trial of rozerem in migraine headaches
Takeda Pharmaceuticals North America
Phase 4
24
October 2006
July 2009 (closed)

NDA, New Drug Application; NINCDS, National Institute of Neurological Disorders and Stroke.

2011 Ongoing Clinical Trials in Migraine and Chronic Daily Headache

Investigational Treatment
Mechanism of Action
Study
Sponsor
Phase
# Subjects
Start Date
End Date

Acute treatments

 Metoclopramide
Dopamine 2 receptor antagonist
Metoclopramide for acute migraine: a dose finding study
Montefiore Medical Center
Phase 3
330
April 2008
May 10 (results pending)

 Metoclopramide and ketoprofen
Dopamine 2 receptor antagonist and NSAID
Randomized controlled trial on the effectiveness of metoclopramide alone or in combination with ketoprofen in acute migraine of child
IRCCS Burlo Garofolo
Phase 3
120
February 2009
June 10, 2010 (results pending)

 BGG492
AMPA antagonist
A 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 BGG492
Novartis
Phase 2
75
April 2009
August 2010 (results pending)

Prophylactic treatments

 Occipital nerve stimulation
Neurostimulation
Precision implantable stimulator for migraine study – occipital nerve stimulation for migraine
Boston Scientific Corporation
Phase 3
179
February 2006
March 2011

 Bupivicaine/methylprednisolone
Local anesthetic and steroid
Greater occipital nerve block for migraine prophylaxis
Mayo Clinic
Phase 4
70
June 2009
May 2011

 DR‐105
Hormone
A multicenter, randomized, double‐blind study to evaluate the efficacy of DR‐105 compared to placebo for the management of menstrually related migraine headaches
Teva Women's Health
Phase 2
120
November 2008
June 2011

 Telcagepant
CGRP antagonist
Telcagepant for prevention of menstrually related migraine in female patients with episodic migraine
Merck
Phase 3
4500
June 2010
September 2011

 LY2300559
Unknown
A randomized, double‐blind, placebo controlled proof of concept study of LY2300559 in patients with migraine
Eli Lilly
Phase 2
118
October 2010
April 2012

 Cyclobenzaprine hydrochloride

Efficacy and safety of cyclobenzaprine hydrochloride extended release for the treatment of chronic migraine
University of Medicine and Dentistry New Jersey|Cephalon
Phase 3
70
July 2010
July 2012

 AMPLATZER® PFO Occluder Device
PFO closure
PRIMA PFO migraine trial
AGA Medical Corporation
Phase 2
144
May 2006
January 2013

 Candesartan cilexitil

Candesartan vs propranolol for migraine prevention
University of Science and Technology|AstraZeneca|St. Olavs Hospital|Kragerø Tablettproduksjon as, Norway
Phase 2/3
72
April 2009
April 2013

 Ethosuximide

Comparison of a drug and placebo in the prevention of migraine headaches
Department of Veterans Affairs, Thomas Jefferson University, University of Pittsburgh
Phase 2
128
June 2010
October 2013

 Occipital nerve stimulation
Neurostimulation
A prospective, randomized, double‐blind, placebo‐controlled trial of occipital nerve stimulation for drug refractory migraine
Boston Scientific Corporation
Phase 2
25
May 2006
December 2013

 Duloxetine

Jefferson Lilly
Unknown
Unknown
Unknown
Unknown

 NXN‐462

NeurAxon Inc.
Phase 2
Unknown
January 2011
Unknown

Chronic daily headache

 Oxytocin
Hormone
Effect of intranasal oxytocin on headache in chronic daily headache
MedVadis Research Corporation/Trigemina, Inc..
Phase 2
80
November 2009
November 2010

AMPA, α‐amino‐3‐hydroxyl‐5‐methyl‐4‐isoxazole‐propionate; CGRP, calcitonin gene‐related peptide; NSAID, non‐steroidal anti‐inflammatory drug; PFO, patent foramen ovale.