Lasmiditan for Migraine

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
MigraineLasmiditan - Drug
Eligibility
6 - 17
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and effectiveness of lasmiditan in treating migraines in children aged 6-17. Up to 4 visits over 20 weeks may be required.

Eligible Conditions
  • Migraine

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: 48 Hours Postdose

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 Most Bothersome Symptom (MBS)-Free
Percentage of Participants Nausea-Free
Percentage of Participants Phonophobia-Free
Percentage of Participants Photophobia-Free
Percentage of Participants with Pain Freedom (Age Sub-Groups)
Percentage of Participants with Pain Freedom (High Dose)
Percentage of Participants with Pain Freedom (Low Dose)
Percentage of Participants with Pain Freedom (Mid Dose)
Percentage of Participants with Pain Relief
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"
48 Hours Postdose
Percentage of Participants Using Additional Medication for Migraine
Percentage of Participants with Sustained Pain Freedom

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Lasmiditan 100mg
16%Dizziness
8%Somnolence
5%Paraesthesia
5%Fatigue
4%Nausea
2%Asthenia
2%Lethargy
2%Vomiting
1%Muscle twitching
1%Balance disorder
1%Restless legs syndrome
1%Anxiety
1%Euphoric mood
1%Tremor
1%Upper respiratory tract infection
1%Back pain
1%Muscle spasms
1%Hypoaesthesia
1%Migraine
1%Hallucination
1%Feeling abnormal
1%Muscular weakness
1%Insomnia
1%Restlessness
1%Vertigo
1%Diarrhoea
1%Feeling jittery
1%Urinary tract infection
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02565186) in the Lasmiditan 100mg ARM group. Side effects include: Dizziness with 16%, Somnolence with 8%, Paraesthesia with 5%, Fatigue with 5%, Nausea with 4%.

Trial Design

4 Treatment Groups

Lasmiditan Low Dose
1 of 4
Lasmiditan High Dose
1 of 4
Lasmiditan Mid Dose
1 of 4
Placebo
1 of 4

Experimental Treatment

Non-Treatment Group

1633 Total Participants · 4 Treatment Groups

Primary Treatment: Lasmiditan · Has Placebo Group · Phase 3

Lasmiditan Low DoseExperimental Group · 2 Interventions: Placebo, Lasmiditan · Intervention Types: Drug, Drug
Lasmiditan High DoseExperimental Group · 2 Interventions: Placebo, Lasmiditan · Intervention Types: Drug, Drug
Lasmiditan Mid DoseExperimental Group · 2 Interventions: Placebo, Lasmiditan · Intervention Types: Drug, Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640
Lasmiditan
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 hours postdose

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,468 Previous Clinical Trials
3,133,942 Total Patients Enrolled
25 Trials studying Migraine
8,853 Patients Enrolled for Migraine
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PMStudy DirectorEli Lilly and Company
3 Previous Clinical Trials
1,477 Total Patients Enrolled
1 Trials studying Migraine
1,000 Patients Enrolled for Migraine

Eligibility Criteria

Age 6 - 17 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Does your child weigh 33 pounds or more?
Does your child have 2-8 migraines a month?
Is your child able to swallow a tablet?
Was your child diagnosed with migraines more than 6 months ago?
People involved must have a weight of at least 15 kilograms.

Who else is applying?

What state do they live in?
North Carolina16.7%
Louisiana16.7%
Arizona16.7%
Other50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Jackson Memorial Hospital25.0%
Children's Hospital of New Orleans LCMC Health25.0%
Long Beach Memorial Medical Center25.0%
Other25.0%
What portion of applicants met pre-screening criteria?
Met criteria57.1%
Did not meet criteria42.9%