A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
| Status: | Not yet recruiting | 
|---|---|
| Conditions: | Migraine Headaches | 
| Therapuetic Areas: | Neurology | 
| Healthy: | No | 
| Age Range: | 18 - Any | 
| Updated: | 4/5/2019 | 
| Start Date: | June 20, 2019 | 
| End Date: | March 29, 2021 | 
| Contact: | There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 
| Email: | ClinicalTrials.gov@lilly.com | 
| Phone: | 1-317-615-4559 | 
Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
The reason for this study is to see how effective and safe the study drug known as lasmiditan
is in the acute treatment of 4 migraine attacks with or without aura.
			is in the acute treatment of 4 migraine attacks with or without aura.
Inclusion Criteria:
- Migraine with or without aura fulfilling the International Headache Society (IHS)
diagnostic criteria 1.1 and 1.2.1
- History of disabling migraine for at least 1 year
- Migraine onset before the age of 50 years
- History of 3 to 8 migraine attacks per month (<15 headache days per month) during the
past 3 months
- MIDAS score ≥11
- Able and willing to complete an eDiary to record the details of each migraine attack
treated with study drug
- Women of child-bearing potential must be using or willing to use a highly effective
form of contraception
- Agree not to post any personal medical data or information related to the study on any
website or social media site until the entire trial has completed
Exclusion Criteria:
- Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
- History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing
the participant at increased risk of seizures
- History of recurrent dizziness and/or vertigo including benign paroxysmal positional
vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders
- History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or
neuropathy)
- History of orthostatic hypotension with syncope
- Significant renal or hepatic impairment in the opinion of the investigator or if they
meet hepatic monitoring criteria
- Participants who, in the investigator's judgment, are actively suicidal and therefore
deemed to be at significant risk for suicide
- History, within past 12 months, of chronic migraine or other forms of primary or
secondary chronic headache disorder (eg, hemicranias continua, medication overuse
headache where headache frequency is ≥15 headache days per month)
- Use of more than 3 doses per month of either opioids or barbiturates
- Initiation of or a change in concomitant medication to reduce the frequency of
migraine episodes within 3 months prior to screening
- Pregnant or breast-feeding women
- History of drug or alcohol abuse/dependence within 1 year prior to screening
- Any medical condition or clinical laboratory test which in the judgment of the
investigator makes the participant unsuitable for the study
- Currently enrolled in any other clinical study involving an investigational product
- Relatives of, or staff directly reporting to, the Investigator
- Participants who are employees of the sponsor
We found this trial at
    18
    sites
	
								Bronx, New York 10461			
	
			
					Principal Investigator: Richard Lipton
			
						
										Phone: 718-405-8360
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								Amherst, New York 14226			
	
			
					Principal Investigator: Shivang G Joshi
			
						
										Phone: 716-558-5670
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								Bellevue, Washington 98007			
	
			
					Principal Investigator: Arifulla Khan
			
						
										Phone: 425-453-0404
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								Chicago, Illinois 60614			
	
			
					Principal Investigator: Alexander P Feoktistov
			
						
										Phone: 773-388-6390
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								Covington, Louisiana 70433			
	
			
					Principal Investigator: Maria C Wilson
			
						
										Phone: 985-246-2800
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								Englewood, Colorado 			
	
			
					Principal Investigator: Cori K Millen
			
						
										Phone: 720-336-4300
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								Huntsville, Alabama 35805			
	
			
					Principal Investigator: Belinda Savage-Edwards
			
						
										Phone: 256-885-9708
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								La Jolla, California 92121			
	
			
					Principal Investigator: Hossein Ansari
			
						
										Phone: 858-657-8540
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								Las Vegas, Nevada 89113			
	
			
					Principal Investigator: Abraham Nagy
			
						
										Phone: 702-749-7147
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									1 Medical Center Dr
Lebanon, New Hampshire 03756
	
			Lebanon, New Hampshire 03756
 (603) 650-5000 
							 
					Principal Investigator: Stewart J Tepper
			
						
										Phone: 603-650-5104
					
		Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...  
  
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								Linz, Oberösterreich 			
	
			
					Principal Investigator: Christian Lampl
			
						
										Phone: 4373276777000
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								Phoenix, Arizona 85013			
	
			
					Principal Investigator: Kerry L Knieval
			
						
										Phone: 602-406-6262
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								Plainview, New York 11803			
	
			
					Principal Investigator: Ira M Turner
			
						
										Phone: 516-822-2230
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									3862 Mexico Road
Saint Peters, Missouri 63303
	
			
					Saint Peters, Missouri 63303
Principal Investigator: Timothy R Smith
			
						
										Phone: 636-387-5100
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								Toledo, Ohio 43606			
	
			
					Principal Investigator: Gretchen E Tietjen
			
						
										Phone: 419-383-6187
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									3800 Reservoir Rd NW
Washington, District of Columbia 20007
	
			Washington, District of Columbia 20007
(202) 444-2000
							 
					Principal Investigator: Jessica Ailani
			
						
										Phone: 703-288-6931
					
		Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...  
  
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								Washington, District of Columbia 			
	
			
					Principal Investigator: Amanda Tinsley
			
						
										Phone: 202-677-6765
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