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.