The reason for this study is to see if lasmiditan is safe and effective in children aged 6 to 17 with migraine. The study will last up to 20 weeks and may include up to 4 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,633
Administered orally
Administered orally
Percentage of Participants with Pain Freedom (High Dose)
Percentage of Participants with Pain Freedom (High Dose)
Time frame: 2 Hours Postdose
Percentage of Participants with Pain Freedom (Mid Dose)
Percentage of Participants with Pain Freedom (Mid Dose)
Time frame: 2 Hours Postdose
Percentage of Participants with Pain Freedom (Low Dose)
Percentage of Participants with Pain Freedom (Low Dose)
Time frame: 2 Hours Postdose
Percentage of Participants with Pain Freedom (Age Sub-Groups)
Percentage of Participants with Pain Freedom (Age Sub-Groups)
Time frame: 2 Hours Postdose
Percentage of Participants with Pain Relief
Percentage of Participants with Pain Relief
Time frame: 2 Hours Postdose
Percentage of Participants Most Bothersome Symptom (MBS)-Free
Percentage of Participants MBS-Free
Time frame: 2 Hours Postdose
Percentage of Participants Nausea-Free
Percentage of Participants Nausea-Free
Time frame: 2 Hours Postdose
Percentage of Participants Photophobia-Free
Percentage of Participants Photophobia-Free
Time frame: 2 Hours Postdose
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Central Research Associates
Birmingham, Alabama, United States
COMPLETEDRehabilitation & Neurological Services
Huntsville, Alabama, United States
RECRUITINGPhoenix Children's Hospital
Phoenix, Arizona, United States
NOT_YET_RECRUITINGPerseverance Research Center
Scottsdale, Arizona, United States
RECRUITINGCenter for Neurosciences
Tucson, Arizona, United States
RECRUITINGArkansas Children's
Little Rock, Arkansas, United States
COMPLETEDCore Healthcare Group
Cerritos, California, United States
COMPLETEDPine Street Pediatrics
Exeter, California, United States
COMPLETEDSun Valley Research Center
Imperial, California, United States
COMPLETEDMiller Children's & Women's Hospital Long Beach
Long Beach, California, United States
NOT_YET_RECRUITING...and 140 more locations
Percentage of Participants Phonophobia-Free
Percentage of Participants Phonophobia-Free
Time frame: 2 Hours Postdose
Percentage of Participants with Sustained Pain Freedom
Percentage of Participants with Sustained Pain Freedom
Time frame: 24 Hours Postdose
Percentage of Participants with Sustained Pain Freedom
Percentage of Participants with Sustained Pain Freedom
Time frame: 48 Hours Postdose
Percentage of Participants Using Additional Medication for Migraine
Percentage of Participants Using Additional Medication for Migraine
Time frame: 24 Hours Postdose
Percentage of Participants Using Additional Medication for Migraine
Percentage of Participants Using Additional Medication for Migraine
Time frame: 48 Hours Postdose
Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely")
Degree of Migraine Interference in Normal Activities: Percentage of Participants with a Rating of 0 ("Not at All"), 1 ("a Little"), 2 ("a Lot"), or 3 ("Completely")
Time frame: 2 Hours Postdose
Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"
Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"
Time frame: 24 Hours Postdose