A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine

Phase 3

Recruiting

• Conditions: Migraine
• Interventions: Drug: Placebo; Drug: Lasmiditan

• Registration Number: NCT04396236
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-20
• Study Start: 2020-06-15
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-11
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1633

Inclusion Criteria

• Participants must have a history of migraine with or without aura as defined by International Headache Society International Classification of Headache Disorders, 3rd edition (ICHD-3) (ICHD-3 2018) diagnostic criteria 1.1 or 1.2.1 and meets the following criteria:

  • History of migraine attacks for more than 6 months
  • Reports at least 2 and no more than 8 moderate-to-severe migraine attacks per month in the 2 months prior to screening visit
  • Duration of a typical untreated migraine attack (excluding sleep) is greater than or equal to 3 hours
  • Participant has not, by history, experienced satisfactory response with a previous migraine therapy, in the opinion of the investigator

• Participant must be able to swallow a tablet

• For participants taking migraine preventive medication, treatment regimen is stable and has been taken for at least 3 months prior to screening

• Participants must weigh at least 15 kilograms (kg)

Exclusion Criteria

• Participants must not be pregnant or nursing
• Participants must not have any acute, serious, or unstable medical condition
• Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo administered orally.
Lasmiditan Mid Dose	Placebo	Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan Low Dose	Placebo	Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan High Dose	Placebo	Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan Mid Dose	Lasmiditan	Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan High Dose	Lasmiditan	Lasmiditan administered orally with matching placebo to maintain the blind.
Lasmiditan Low Dose	Lasmiditan	Lasmiditan administered orally with matching placebo to maintain the blind.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Pain Freedom (High Dose)	2 Hours Postdose	Percentage of Participants with Pain Freedom (High Dose)

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with Pain Freedom (Mid Dose)	2 Hours Postdose	Percentage of Participants with Pain Freedom (Mid Dose)
Percentage of Participants with Pain Freedom (Low Dose)	2 Hours Postdose	Percentage of Participants with Pain Freedom (Low Dose)
Percentage of Participants with Pain Freedom (Age Sub-Groups)	2 Hours Postdose	Percentage of Participants with Pain Freedom (Age Sub-Groups)
Percentage of Participants with Pain Relief	2 Hours Postdose	Percentage of Participants with Pain Relief
Percentage of Participants Nausea-Free	2 Hours Postdose	Percentage of Participants Nausea-Free
Percentage of Participants Most Bothersome Symptom (MBS)-Free	2 Hours Postdose	Percentage of Participants MBS-Free
Percentage of Participants with Sustained Pain Freedom	48 Hours Postdose	Percentage of Participants with Sustained Pain Freedom
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")	2 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")
Percentage of Participants Photophobia-Free	2 Hours Postdose	Percentage of Participants Photophobia-Free
Percentage of Participants Phonophobia-Free	2 Hours Postdose	Percentage of Participants Phonophobia-Free
Percentage of Participants Using Additional Medication for Migraine	48 Hours Postdose	Percentage of Participants Using Additional Medication for Migraine
Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"	24 Hours Postdose	Acceptability of the Formulation: Percentage of Participants with a Rating of "Very Easy," "Easy," "Neither Easy nor Hard," "Hard," or "Very Hard"

Trial Locations

Locations (147)

Central Research Associates; 🇺🇸 Birmingham, Alabama, United States

Rehabilitation & Neurological Services; 🇺🇸 Huntsville, Alabama, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Perseverance Research Center; 🇺🇸 Scottsdale, Arizona, United States

Center for Neurosciences; 🇺🇸 Tucson, Arizona, United States

Arkansas Children's; 🇺🇸 Little Rock, Arkansas, United States

Core Healthcare Group; 🇺🇸 Cerritos, California, United States

Pine Street Pediatrics; 🇺🇸 Exeter, California, United States

Sun Valley Research Center; 🇺🇸 Imperial, California, United States

Miller Children's & Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States

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