Migraine MedDRA version: 20.0 Level: PT Classification code 10027599 Term: Migraine System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Are of an acceptable age to provide informed consent according to the local regulations and are at least 18 years of age at time of screening with migraine with or without aura fulfilling the IHS (International Headache Society) diagnostic criteria 1.1 or 1.2. - 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
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 -Patients 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the efficacy of lasmiditan 200 mg and 100 mg on migraine headache pain freedom compared to placebo. - To evaluate the consistency of response to lasmiditan 200 mg and 100 mg compared to placebo.;Secondary Objective: -To evaluate the efficacy of lasmiditan 200 mg and 100 mg on freedom from MBS compared to placebo. - To evaluate the efficacy of lasmiditan 200 mg and 100 mg on pain relief compared to placebo.;Primary end point(s): 1. Percentage of patients in each group that are pain free (defined as mild, moderate, or severe headache pain becoming none). 2. Percentage of patients in each group that are pain free (defined as mild, moderate, or severe headache pain becoming none).;Timepoint(s) of evaluation of this end point: 1: at 2 hours postdose during the first attack. 2: at 2 hours postdose in at least 2 out of 3 attacks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 3. Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated with Migraine. 4. Percentage of Participants with Pain Relief. 5. Percentage of Participants with 24-Hour Sustained Pain Freedom during the First Attack. 6. Percentage of Participants Requiring Rescue Medication for Migraine. 7. Percentage of Participants that are Free of Symptoms Associated with Migraine. 8. Percentage of Participants with Migraine Recurrence. 9. Percentage of Participants with Pain Freedom, Pain Relief, Freedom from MBS, and No Disability During First Attack. 10. Change from Baseline in Total Score as Measured by the MIDAS Scale. 11. Percentage of Participants with no Disability as Measured by the Disability Item. 12. Percentage of Participants Very Much or Much Better as Measured by Patient Global Impression of Change (PGI-C). 13. Mean HRQoL score for domains of social functioning, migraine symptoms, and feelings/concerns, as measured by the 24-hour MQoLQ. 14. Change from Baseline in Utility as Measured by the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L). 15. Percentage of Participants with Pain Relief. 16. Percentage of Participants that are Pain Free. 17. Percentage of Participants with Pain Relief.;Timepoint(s) of evaluation of this end point: 3. at 2 Hours Postdose During the First Attack. 4. at 2 Hours Postdose during the First Attack. 5. with 24-Hour Sustained Pain Freedom during the First Attack. 6. within 24 Hours of Treatment during the First Attack. 7. at 2 Hours Postdose During the First Attack. 8. at 24 Hours During the First Attack. 9. 2 Hours Postdose. 10. Baseline, Week 16. 11. at 2 Hours Postdose during the First Attack. 12. at 2 hours Postdose during the first attack. 13. at 24 hours post first dose of study during first attack. 14. Baseline, 24 Hours Postdose. 15. at 2 Hours Postdose in at Least 2 out of 3 Attacks 16, 17. at 2 Hours Postdose in at Least 3 out of 4 Attacks. | — |
Countries
Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Hungary, India, Italy, Mexico, Netherlands, Russian Federation, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed