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 | LLT |
E.1.2 | Classification code | 10066635 |
E.1.2 | Term | Acute migraine |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 | 10052787 |
E.1.2 | Term | Migraine without aura |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10027603 |
E.1.2 | Term | Migraine headaches |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027607 |
E.1.2 | Term | Migraine with aura |
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 |
Primary objective To evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first and as a second dose, in the acute treatment of migraine. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives To explore the long-term efficacy of lasmiditan 100 mg and lasmiditan 200 mg in terms of headache response over time.
Additional Objectives To compare patient reported resource utilization during the study to patient reported information from COL MIG-301 or COL MIG-302 in terms of cardiovascular events and in terms of migraine episodes. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Protocol Addendum COL MIG-305(1)/H8H-CD-LAHL (1) (Subjects with Prior Lasmiditan Exposure) An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR), Addendum 1 dated 20 October 2017
To obtain long-term safety and efficacy data in additional subjects treated with lasmiditan for migraine headache, this addendum is a substudy of COL MIG-305 (LAHL) and will allow enrollment into COL MIG- 305 (LAHL) of subjects who previously participated in COL MIG-302, but for whom completion of one of these studies occurred >12 weeks prior to being screened for COL MIG-305 (LAHL). |
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E.3 | Principal inclusion criteria |
All subjects entered into this trial must meet the following criteria: 1. Able and willing to give written informed consent 2. Completed COL MIG-301 or COL MIG-302. 3. Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, IUD, abstinence, or vasectomized partner). 4. Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.
Inclusion criteria for sub-study use this subsection in addition to the corresponding subsection (with the exception of inclusion criterion #2) in the main protocol: [12] Have completed either COL MIG-301 or COL MIG-302. [13] Have a Migraine Disability Assessment score (MIDAS) score ≥11 (see Appendix 2 of the main protocol)
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E.4 | Principal exclusion criteria |
Subjects will be excluded from this trial if they meet any of the following criteria: 1. Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study. 2. Pregnant or breast-feeding women. 3. Women of child-bearing potential not using or not willing to use highly effective contraception. 4. Subject is at imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS). 5. Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG-301 or COL MIG-302. 6. Subject did not dose a migraine during the allotted time while enrolled in COL MIG-301 or COL MIG-302 or was evaluated to be non compliant with the e-diary requirements (particularly recording their migraine and post-dose assessments).
Exclusion criteria sub-study Use this subsection in addition to the corresponding subsection in the main protocol: [5] Exclusion criterion #5 from the main protocol (Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301 or COL MIG-302) is not exclusionary for those subjects participating in this protocol addendum and has been deleted. [14] Subject did not dose a migraine during the allotted time while enrolled in COL MIG-302 or was evaluated to be noncompliant with the e-diary requirements (particularly recording their migraine and post-dose assessments). In exceptional circumstances, and with the prior approval of the Sponsor, patients previously considered ineligible due to this criterion may be reconsidered. Refer to the main protocol for the remainder of Section 6. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients and the proportion of attacks associated with any adverse event and with specific adverse events. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
calculated for each 3 months period |
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E.5.2 | Secondary end point(s) |
The proportion of migraine attacks treated with lasmiditan 100 mg and with lasmiditan 200 mg which respond at 2 hours, calculated for each 3 month period. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 hours post-dose, calculated for each 3 months period |
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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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To compare patient reported resource utilization during the study to patient reported information fr |
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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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
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 |
Germany |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |