E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- 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. |
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E.2.2 | Secondary objectives of the trial |
-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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 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). ∙ 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 until 30 days after the last dose. ∙ 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. ∙ Are able and willing to give signed informed consent
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | 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. |
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E.5.2 | 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. |
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E.5.2.1 | 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.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 76 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Belgium |
China |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
India |
Italy |
Mexico |
Netherlands |
Russian Federation |
Spain |
Switzerland |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the study is the date of the last visit or last scheduled procedure shown in the Schedule of Activities for the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 13 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 13 |