Migraine Research Studies

AMGEN PROTOCOL 20170-703

Phase 4, randomized double blind, placebo controlled, parallel-group study to evaluate the efficacy and safety of erenumab in adults with chronic migraine and medication overuse headache. 

  • PI:  ANDREA HALLER, MD
  • CONTACT MEGAN  EXT 2179
  • Duration of 28 weeks Extended study offered.

KEY INCLUSION CRITERIA

  • 18 years old and over.
  • Chronic migraine for > 12 months
  • Documented hx of chronic headache for a minimal duration of 6 month before screening.
  • Concomitant treatment with 1 oral migraine preventive medication is allowed if it is stable > 2 months.
  • Greater than 14 days of headache which > 8 meet criteria for migraine days.
  • Hx of treatment failure with at least 1 preventive treatment as defined as discontinuation due to lack of efficacy, year

KEY EXCLUSION CRITERIA

  • History of hemiplegic migraine, cluster headache or other trigeminal autonomic cephalalgia.
  • Changes in drug regimen of allowed migraine preventive medication with 2 months from screening.
  • Received Botox in the head or neck region within 4 months prior to screening.
  • Currently diagnosed with a clinically significant cervical or intracranial disease.
  • Documented history of treatment with an anti-CGRP

ALLERGAN PROTOCOL 3101-304-002

Phase 3-multicenter randomized double blind, placebo-controlled parallel group study to evaluate the efficacy, safety, and tolerability of oral atogepant for the prophylaxis of migraine in participants with episodic migraine who have previously failed 2 to 4 classes of oral prophylactic treatments 

  • PI: ANDREA HALLER, MD
  • CONTACT MEGAN  EXT 2179
  • Duration of study 16 weeks- extended study available.

KEY INCLUSION CRITERIA

  • At least 1 year of migraine.
  • 4-14 migraine days per month on average in the 3 months prior to Visit 1.
  • The following rescue medications for acute tx of migraine are allowed.  Any triptan, any ergot derivative, any other form of analgesic, an NSAID agent.  Any antiemetic agent.
  • Must have failed oral migraine prophylaxis meds from 2 to 4 of the med classes.  Propranolol, metoprolol, atenolol, bisoprolol, timolol or nadolol, topiramate, flunarizine, valproate or divalproex, amitriptyline or nortriptyline, venlafaxine, desvenlafaxine or desvenlafaxine, lisinopril, candesartan, oxeterone or pizotifen.

KEY EXCLUSION CRITERIA

  • Use of butalbital-containing analgesics.
  • > 15 days/month or any usage of opioid-containing meds 3 months prior to Visit 1.

LILLY PEDIATRIC MIGRAINE STUDY-H8H-MC-LAHV:    LASMIDITAN  SHORT STUDY-ONE TREATMENT WITH STUDY DRUG AND STUDY COMPLETED-EXTENDED STUDY AVAILBLE LAHW.

Pediatric options for migraine relief:  A randomized, double blind, placebo-controlled study of Lasmiditan for acute treatment of migraine.

  • PI:  ANDREA HALER, MD
  • CONTACT: MEGAN EXT 2179

KEY INCLUSION CRITERIA

  • Ages 6 thru 17.
  • Minimum body weight of 15 kg
  • History of migraine attacks for more than 6 months.
  • Reports at least 2 and no more than 8 moderates to severe attacks per month in the 2 months prior to screening.
  • Must be able to swallow a tablet.
  • Patient’s taking migraine preventative meds, treatment regimen is stable and has been taken for at least 3 months.

BIOHAVEN BHV 3500-301:  NASAL SPRAY ZAVEGEPANT, ACUTE MIGRAINE TREATMENT-ONE AND DONE STUDY.

BHV3500-301: Phase 3: Double-Blind, Randomized, Placebo Controlled, Safety and Efficacy Trial of BHV3500 (zavegepant) Intranasal (IN) for the Acute Treatment of Migraine.

  • PI:  ANDREA HALLER, MD
  • CONTACT: MINDY   EXT 2185
  • NO EXTENDED STUDY AVAILABLE.

KEY INCLUSION CRITERIA

  • Subjects with minimum 1 year history of migraines (with or without aura)
  • Not more than 8 attacks of moderate or severe intensity per month within last 3 months.
  • At least 2 consistent migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and throughout the Screening Period (subject self-report).
  • Less than 15 days with headaches (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Period (subject self-report)
  • Subjects on prophylactic migraine medication are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to screening visit, and if the dose is not expected to change

KEY EXCLUSTION CRITERIA

  • Body mass index > 35 kg/m.