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    Summary
    EudraCT Number:2015-005674-37
    Sponsor's Protocol Code Number:COL-MIG-305(H8H-CD-LAHL)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2015-005674-37
    A.3Full title of the trial
    An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
    Eine offene Langzeit-Sicherheitsstudie zu Lasmiditan (100 mg und 200 mg) in der Akutbehandlung der Migräne (GLADIATOR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to study the safety of long term use of lasmiditan 100 mg and 200 mg in the treatment of migraine
    A.3.2Name or abbreviated title of the trial where available
    GLADIATOR
    A.4.1Sponsor's protocol code numberCOL-MIG-305(H8H-CD-LAHL)
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEli Lilly and Company
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportCoLucid Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly and Company
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post codeIN 42685
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trial@lilly.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namelasmiditan
    D.3.2Product code COL-144
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlasmiditan
    D.3.9.1CAS number 439239-92-6
    D.3.9.2Current sponsor codeCOL-144
    D.3.9.3Other descriptive namelasmiditan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namelasmiditan
    D.3.2Product code COL-144
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlasmiditan
    D.3.9.1CAS number 439239-92-6
    D.3.9.2Current sponsor codeCOL-144
    D.3.9.3Other descriptive namelasmiditan
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute migraine
    E.1.1.1Medical condition in easily understood language
    acute migraine
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066635
    E.1.2Term Acute migraine
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10052787
    E.1.2Term Migraine without aura
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10027603
    E.1.2Term Migraine headaches
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027599
    E.1.2Term Migraine
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10027607
    E.1.2Term Migraine with aura
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full 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).
    E.3Principal 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 within the last 12 weeks.
    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)
    E.4Principal 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. Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301 or COL MIG-302.
    6. Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG-301 or COL MIG-302.
    7. 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 noncompliant 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.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients and the proportion of attacks associated with any adverse event and with specific adverse events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Calculated for each 3 months period
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 hours post-dose, calculated for each 3 months period
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    2 doses of lasmiditan
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If 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
    E.8.7Trial 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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2451
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 129
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-07-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state305
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 414
    F.4.2.2In the whole clinical trial 2580
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    standard of care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-01-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-20
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