A Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine (PIONEER-PEDS1)

Lilly

Status and phase: Terminated; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT04396236

2019

16927

2023-506253-38-00 (EU Trial (CTIS) Number)

2023

2019-004378-24 (EudraCT Number)

H8H-MC-LAHV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 847 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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847 participants in 7 patient groups, including a placebo group

Stage 1: Placebo

Placebo Comparator group

Description:

Participants received placebo administered orally to treat a qualifying migraine attack.

Treatment:

Drug: Placebo

Stage 1: 50/100 mg Lasmiditan

Experimental group

Description:

Participants received lasmiditan (50 milligram (mg) for body weight ≤40 kg or 100 mg for body weight \>40 kg) administered orally to treat a qualifying migraine attack.

Treatment:

Drug: Lasmiditan

Stage 2: Placebo (Stage 1 Lasmiditan Non-responders)

Placebo Comparator group

Description:

Participants who did not respond to lasmiditan in stage 1 were randomized in stage 2 to receive placebo administered orally to treat a single migraine attack.

Treatment:

Drug: Placebo

Stage 2: Placebo (Stage 1 Placebo Non-responders)

Placebo Comparator group

Description:

Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive placebo administered once orally to treat a single migraine attack.

Treatment:

Drug: Placebo

Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)

Experimental group

Description:

Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight \>40 kg), administered orally to treat a single migraine attack.

Treatment:

Drug: Lasmiditan

Stage 2: 50/ 100mg Lasmiditan (Stage 1 Placebo Non-responders)

Experimental group

Description:

Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight \>40 kg), administered once orally to treat a single migraine attack.

Treatment:

Drug: Lasmiditan

Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)

Experimental group

Description:

Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight \>40 kg), administered once orally to treat a single migraine attack.

Treatment:

Drug: Lasmiditan