A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Lilly

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Lasmiditan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03670810

2018-001661-17 (EudraCT Number)

17131

H8H-MC-LAIJ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,633 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,633 participants in 9 patient groups, including a placebo group

100 milligram (mg) Lasmiditan

Experimental group

Description:

Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Treatment:

Drug: Lasmiditan

Drug: Placebo

200 mg Lasmiditan

Experimental group

Description:

Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Treatment:

Drug: Lasmiditan

Drug: Placebo

Control 1 Sequence

Placebo Comparator group

Description:

Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Treatment:

Drug: Lasmiditan

Drug: Placebo

Control 2 Sequence

Placebo Comparator group

Description:

Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Treatment:

Drug: Lasmiditan

Drug: Placebo

100 mg Lasmiditan Maximum Extended Enrollment (MEE)

Experimental group

Description:

Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Treatment:

Drug: Lasmiditan

Drug: Placebo

200 mg Lasmiditan MEE

Experimental group

Description:

Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Treatment:

Drug: Lasmiditan

Drug: Placebo

Control 1 Sequence MEE

Placebo Comparator group

Description:

Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Treatment:

Drug: Lasmiditan

Drug: Placebo

Control 2 Sequence MEE

Placebo Comparator group

Description:

Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Treatment:

Drug: Lasmiditan

Drug: Placebo

Open Label Extension

Experimental group

Description:

Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.

Treatment:

Drug: Lasmiditan